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Functional Specification (FS) Version: 1.01 Author: H.-J. Strauss / R. Wittig Date: 08. Mar. 2011 11454-FS-cc01-0101.docx Page 1/93 Customer: Teva Pharmaceuticals Ind. Ltd, Israel Unit: CM 2500 Project: 11454

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Page 1: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Functional Specification (FS)

Version: 1.01 Author: H.-J. Strauss / R. Wittig Date: 08. Mar. 2011 11454-FS-cc01-0101.docx Page 1/93

Customer:

Teva Pharmaceuticals Ind. Ltd, Israel

Unit:

CM 2500

Project:

11454

Page 2: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 2/93

Version Change Description Reason

1.00 none initial version

1.01 section 3.6

New signal and alarm 439/439-1 for exhaust suction.

section 4.3

Alarm "439-1 EXCHAUST SUCTION - SIGNAL FAULT ON not active" added to interlocks for man-ual inertisation.

Condition for activated parts added.

section 6.2

alarm list updated

section 8.2

New interface signals with Teva.

Change No. 1

Glatt order confirmation OC110116

Functional Specification (FS) approved by: Glatt Project Manager

name title signature date

Qualification Coordinator

name title signature date

Teva Pharmaceuticals Ind. Ltd Project Manager

name title signature date

Qualification Coordinator

name title signature date

Page 3: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 3/93

Page 4: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 4/93

Table of Contents

Page

1  Introduction ............................................................................................................. 6 2  Machine Overview and Control System ................................................................ 7 2.1  Machine................................................................................................................... 7 2.2  Principal Controlling of the Machine ........................................................................ 7 2.3  Operation Sequences ............................................................................................. 8 3  Machine oriented Description ................................................................................ 9 3.1  Control air supply line ............................................................................................ 10 3.2  Hydraulic unit P623500 ......................................................................................... 11 3.3  Post hoist (H621000) ............................................................................................ 14 3.3.1  Hydraulic Lifting Device Y621010 ..................................................................... 14 3.3.2  Height Stop Device Y621150 ............................................................................ 16 3.3.3  Docking latch 0 ................................................................................................. 18 3.4  Carriage with blending device (H621500) ............................................................. 19 3.4.1  Blending drive Y621540/Y621541 ..................................................................... 19 3.4.2  Safety chain/door G620010 .............................................................................. 21 3.4.3  Locking cylinders Y621650 / Y621700 .............................................................. 22 3.5  Bracket (H621800) ................................................................................................ 24 3.6  Inertisation system ................................................................................................ 26 3.7  Operator Interface Terminal (OIT) ......................................................................... 31 4  Function oriented description .............................................................................. 33 4.1  Control On/Off ....................................................................................................... 33 4.2  Hydraulic On/Off .................................................................................................... 34 4.3  Manual Inertisation On/Off .................................................................................... 35 4.4  Revision Mode On/Off ........................................................................................... 37 4.4.1  Manual Lifting/Lowering On/Off ......................................................................... 39 4.4.2  Manual Tilting CW/Tilting CCW On/Off ............................................................. 41 4.4.3  Manual latch horizontal position retract/protract ................................................ 43 4.4.4  Manual latch vertical position retract/protract .................................................... 44 4.5  Clamping activate/release ..................................................................................... 45 4.6  Move to clamping position ..................................................................................... 47 4.7  Move to blending position...................................................................................... 49 4.8  Move to dispensing position (1000) ....................................................................... 51 

Page 5: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 5/93

4.9  Move to dispensing position (2500). ...................................................................... 53 4.10  Move to docking position (1000) ........................................................................... 55 4.11  Move to docking position (2500) ........................................................................... 57 4.12  Calibration Move ................................................................................................... 59 4.13  Move to latch position ........................................................................................... 61 4.14  Batch ..................................................................................................................... 63 4.14.1  Batch open ........................................................................................................ 63 4.14.2  Batch close ....................................................................................................... 63 4.14.3  Batch report/ Batch record retention ................................................................. 64 4.15  Recipe-Manager .................................................................................................... 65 4.15.1  Create recipe .................................................................................................... 66 4.15.2  Trippoint ............................................................................................................ 66 4.15.3  Recipe status .................................................................................................... 67 4.15.4  Recipe in automatic mode................................................................................. 69 4.15.5  Recipe in manual mode .................................................................................... 69 4.15.6  Start CM Recipe ................................................................................................ 70 4.15.7  Basic operation (BOP) ...................................................................................... 71 4.15.7.1  Setpoint......................................................................................................... 71 4.15.8  Types of BOP for CM recipe ............................................................................. 72 4.15.8.1  Basic Operation Blending ............................................................................. 72 4.15.8.2  Basic Operation Dispensing.......................................................................... 74 4.15.8.3  Basic Operation Finish .................................................................................. 77 5  System Access/Password Handling .................................................................... 78 6  Alarms .................................................................................................................... 81 6.1  Alarm settling times and alarm delay times ........................................................... 82 6.2  Alarms Overview ................................................................................................... 83 6.3  Alarm shutdown levels .......................................................................................... 85 7  Parameters ............................................................................................................. 87 7.1  Recipe Parameters ............................................................................................... 88 7.1.1  BOP Parameters ............................................................................................... 88 7.1.2  Trippoints .......................................................................................................... 88 7.2  Machine Parameters ............................................................................................. 89 7.2.1  Service Parameter ............................................................................................ 89 7.2.2  Runtime Parameter ........................................................................................... 91 7.2.3  Inertisation Parameter ....................................................................................... 91 8  Interfaces section .................................................................................................. 92 8.1  Interface with users (HMI) ..................................................................................... 92 8.2  Interface with Teva ................................................................................................ 92 

Page 6: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 6/93

Appendix A:  P&I Diagram ........................................................................................ 93 

1 Introduction

This Functional Specification (FS) is provided for the following Glatt machines.

Description Type Project Number P&I-Diagram

Container Blender CM 2500 11454 2-010-22040-3

This Functional Specification (FS) specifies the control system of the machines with the depending functions. The information for this document is based on the order confirmation. Inside this document, we refer to the P&I-Diagram of the unit using the Glatt-numeration-system. The numeration system can be inspected at Glatt. The Functional Specification was written by H.-J. Strauss / R. Wittig with support from the specialists of the corresponding departments.

Page 7: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 7/93

2 Machine Overview and Control System

2.1 Machine

The container mixer, type CM 2500, is intended for blending of pharmaceutical products within containers with rectangular cross-section of max. weight of 1600 kg (container + product). The blending effect is obtained by filling the container up to max. 80% of its capacity. The container with the good to be blended is moved into the blending room by a trans-port device. After it is securely clamped the container is raised into the blending position and rotated at the desired blending speed. A hydraulic cylinder realizes lifting. The lifting force is transmitted to a carriage running within forklift truck profiles. To the carriage there is a plate attached that bears the units for rotation around a horizontal axis (blending axis). The bracket for carrying the con-tainer is screwed on it.

2.2 Principal Controlling of the Machine

The control system consists of a PLC for the machine control functions and a Personal Computer (PC) with the SCADA software MVW and a screen to operate the machine. The PLC and the personal computer are in permanent contact exchanging information. The MVW downloads all nominal values to the PLC and receives all actual parameters and values from the process. Features of MVW are batch reports, recipe handling, access right level handling as well as graphical user interfaces (GUI). In the SCADA a revision mode is implemented as well. Users with the right access level have the possibility to tune the controllers and switch on/off every single device of the plant except the motors and the energy valves (e.g. heating valve, compressed air valve). In this mode no software interlock between the plant devices is active. This mode is only for maintenance and not for production. The MVW enables the supervisor / pharmacist to create recipes. They are based on Basic Operations (BOP), which are individual linked to recipes. Recipes can be loaded, saved and edited.

Page 8: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 8/93

2.3 Operation Sequences

BLENDING A clamped container or drum is tilted on an axis rectangular to the container axis. DISPENSING The container will be inerted, if preselected and product can be filled in during a recipe. FINISH The container moves back to the corresponding docking position.

Page 9: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 9/93

3 Machine oriented Description

This section shall take the high level description, and break it down as far as the level of the individual functions. It shall describe the functions and facilities to be provided, in-cluding specific modes of operation. This subsection contains the description of the main elements of the machine. The following main groups of the machine are:

• Hydraulic unit

• Post hoist

• Carriage with blending device

• Bracket

• Docking Unit with inert gas connection

• Operator Interface Terminal

Page 10: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 10/93

3.1 Control air supply line

a) Usage/Function The control air supply line is for the pneumatic control system.

The following main components are included:

• Compressed air supply filter F000303

• Compressed air pressure control valve/manometer V000313/P000323 Controller without auxiliary energy, no connection to the PLC Manual adjustment with local indication.

• Compressed air pressure P000333

b) Controlling

• P000333 compressed air pressure: - DIN: The actual compressed air pressure is measured by a pressure sensor,

transmitted to the PLC by a digital input signal (P000333).

c) Alarms

The following alarms can occur:

1. Main alarm 167 COMPRESSED AIR SUPPLY PRESSURE (P000333) oc-curs as soon as one of the following sub-alarms appears:

1.1. Alarm 167-1 ACTUAL VALUE < MIN if, no broken wire alarm and actual compressed air supply P000333 < MIN.

Page 11: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 11/93

3.2 Hydraulic unit P623500

a) Usage / Function The hydraulic unit serves for creating of the hydraulic pressure and flow.

The oil tank B623630 contains a heat exchanger W623690 for cooling the hydrau-lic oil and a control for the temperature, sensors for highest tolerable temperature, minimum oil level and correct function of the control.

The following main components are included:

• V623660 cold water valve

• V623670 water block valve

• T623680 oil temperature

• W623690 heat exchanger

• T623610 oil temperature <max.

• L623630 oil level

• PD623620 differential pressure oil filter

• F623620 oil filter

• P623530 actual hydraulic working pressure

• P623640 hydraulic pressure

• P623500 hydraulic pump

• PM623500 motor hydraulic pump

Page 12: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 12/93

b) Controlling

• PM623500 hydraulic Pump: - DOT: Hydraulic will be switched on by a digital output signal DOT from the

PLC (E623500). Feedback signals:

- DIN: for hydraulic switched on - DIN: for malfunction hydraulic - DIN: for controller aggregate ok (E623580) - Actual hydraulic working pressure controlled by the hydraulic unit control

(P623530), which is integrated at the hydraulic pump. - AOT: Hydraulic pressure will be controlled by an analogue output signal from

PLC (U623510). - AOT: Hydraulic flow will be controlled by an analogue output signal from PLC

(U623520). • V623660 cold water valve:

Default position: closed. as soon as the hydraulic pump is switched on the valve will be opened

• T623610 temperature switch: - DIN: The temperature switch will switch off the hydraulic pump motor

PM623500, if the oil exceeds the max. tolerable temperature. The tem-perature switch indicates with a digital input to the PLC (T623610), if the temperature exceeds.

• PD623620 differential pressure switch: - DIN: The differential pressure switch will switch off, if the oil filter F623620 is

dirty. The differential pressure switch indicates with a digital input to the PLC (PD623620), if the differential pressure exceeds.

• L623630 level switch: - DIN: The level switch will switch off the hydraulic pump motor PM623500, if

the oil level in the hydraulic tank is too low. The oil level is indicated with a digital input to the PLC (L623630), if the oil level is too low.

• P623640 pressure indication: Local indication of the hydraulic unit working pressure. Not controlled by the PLC.

• T623680 temperature controller: The temperature controller opens the water block valve V623670, if the temper-ature of the hydraulic oil exceeds the maximal working temperature. Not con-trolled by the PLC.

Page 13: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 13/93

c) Alarms Following alarms can appear:

1. Main alarm 400 HYDRAULIC PUMP (P623500) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 400-1 NOT SWITCHED ON: In case of the hydraulic unit is not switched on.

2. Main alarm 401 HYDRAULIC OIL (B623630) occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 401-1 PD623620 OIL FILTER DIRTY: In case of a too high pressure difference inside the oil filter.

2.2. Alarm 401-2 L623630 OIL LEVEL TOO LOW in case of a too low oil level inside the hydraulic oil reservoir.

2.3. Alarm 401-3 T623610 OIL TEMPERATURE TOO HIGH: In case of a too high temperature of the hydraulic oil an alarm will be generated.

3. Main alarm 402 HYDRAULIC UNIT (E623500) occurs as soon as one of the following sub-alarms appears:

3.1. Alarm 402-1 MALFUNCTION in case of a wrong feedback signal from the control.

3.2. Alarm 402-2 CONTROLLER AGGREGATE in case of a wrong feed-back signal from the aggregate controller (E623580).

Page 14: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 14/93

3.3 Post hoist (H621000)

The post hoist is a welded structure made from constructional steel with a stainless steel housing. It takes up the forces and moments acting during product handling. The post hoist contains sensors necessary in the process for height positions, which are not defined by retractable latches.

3.3.1 Hydraulic Lifting Device Y621010

a) Usage / Function

The hydraulic lifting device Y621010 serves for lifting of the load, which consist of the lifting unit with bracket and container.

The hydraulic lifting device consists of:

• The hydraulic cylinder Y621010, which allows lifting and lowering the load via a chain.

• The hydraulic valve V621020 which will open, if the load is lifted or lowered by the hydraulic cylinder Y621010.

b) Controlling

• V621020 hydraulic valve: - DOT: The valve will be opened by a digital output signal (U621020) from the

PLC in case of hydraulic cylinder lift or lower Default position: closed Manual switch H621090 opens the hydraulic valve, if in case of an emergency the load has to be lifted or lowered

• G620500 limit switch: - DIN: The limit switch G620500 indicates the upper position with a digital in-

put signal to the PLC (G620500). • G620540 limit switch:

- DIN: The limit switch G620540 indicates the lower position with a digital input signal to the PLC (G620540).

• G620600 length transmitter: - AIN: The control system is signalized about the reached height by means of

a rope length transmitter (G620600). The length transmitter indicates the height with an analogue input signal (AIN) to the PLC (G620600).

Page 15: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 15/93

c) Alarms Following alarms can appear:

1. Main alarm 404 HIGHEST POSITION (G620500) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 404-1 FEEDBACK SIGNAL FAULT: REACHED In case of a wrong feedback signal from the sensor after a delay time an alarm will be generated.

2. Main alarm 405 INTERMEDIATE POSITION (G620540) occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 405-1 FEEDBACK SIGNAL FAULT: REACHED In case of a wrong feedback signal from the sensor after a delay time an alarm will be generated.

3. Main alarm 409 DESTINATION POSITION (G620600) occurs as soon as one of the following sub-alarms appears:

3.1. Alarm 409-1 FEEDBACK SIGNAL FAULT: REACHED In case of destination position is not reached after a delay time an alarm will be generated.

3.2. Alarm 409-7 BROKEN WIRE, in case of control enabled and broken wire is detected.

Page 16: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 16/93

3.3.2 Height Stop Device Y621150

a) Usage / Function

The pneumatically actuated height stop locks the container at the blending position during blending. The height stop has an adjustable range and is pneumatically re-tracted to lower the container. Sensors monitor the height stop lock and prevent operation, if not properly seated.

b) Controlling

• Y621150 height stop device: - DOT: The height stop device will be activated by two digital output signals

from PLC (U621150). • G621160 limit switch:

- DIN: Limit switch G621160 indicates a digital input signal to the PLC (G621160), if the height stop device is pivoted in.

• G621170 limit switch: - DIN: Limit switch G621170 indicates a digital input signal to the PLC

(G621170) if the height stop device is pivoted out. • G621180 limit switch:

- DIN: Limit switch G621180 indicates a digital input signal to the PLC (G621180), if the height stop device is loaded.

Page 17: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 17/93

c) Alarms Following alarms can appear:

1. Main alarm 408 HEIGHT STOP DEVICE (Y621150) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 408-1 FEEDBACK SIGNAL FAULT: PIVOTED OUT In case of a wrong or missing feedback signal from the sensor after a delay time an alarm will be generated.

1.2. Alarm 408-2 FEEDBACK SIGNAL FAULT: PIVOTED IN In case of a wrong or missing feedback signal from the sensor after a delay time an alarm will be generated.

2. Main alarm 419 HEIGHT STOP DEVICE (G621180) occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 419-1 FEEDBACK SIGNAL FAULT: SIGNAL LOST In case of the container is blending and the latch G621180 is not loaded an alarm will be generated.

Page 18: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 18/93

3.3.3 Docking latch 0

a) Usage / Function

The docking latch device 0 serves for determining the accurate docking height for the small container.

b) Controlling / Machine parameter / Process parameter

• G620940 limit switch: - DIN: Limit switch G620940 indicates a digital input signal to the PLC

(G620940) if the docking latch has been loaded.

c) Alarms

Following alarms can appear:

1. Main alarm 406 DOCKING POSITION (G620940) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 406-1 FEEDBACK SIGNAL FAULT: LOADED In case of a wrong or missing feedback signal from the sensor after a delay time an alarm will be generated.

Page 19: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 19/93

3.4 Carriage with blending device (H621500)

The blending device H621500 is attached to the carriage that runs within the post hoist. It comprises:

- - the blending drive with all the necessary components for blending, es-pecially the ball bearing slewing rim with external teeth, the hydraulic motors with brakes and pinions, the lubricating nipples, and

- - the interlock with slewing-in catch that ensures accurate horizontal posi-tion of the bracket after blending

3.4.1 Blending drive Y621540/Y621541

a) Usage / Function The blending drive transmits by hydraulic motors with their pinions the rotating mo-tion to the ball bearing slewing rim to which the bracket with the container is at-tached. Blending is made in clock-wise (CW) direction away from the interlock.

It consists of:

• the 2 hydraulic motors Y621540 and Y621541

• V621510 hydraulic valve, which will open for hydraulic flow in one direction, if the tilting/blending direction should be CW and in the other direction, if the tilting direction should be counter clock-wise (CCW).

b) Controlling

• Blending speed S621580 - DIN: S621580 generates an impulse for each tooth of the ball bearing slew-

ing rim. This impulse will be converted into a frequency value by a spe-cial frequency input card for the PLC. Thus the PLC can measure and indicate the blending speed. According to the measured rotating speed the drive speed can be automatically corrected in a limited range.

• Hydraulic valve V621510: - DOT: The valve is controlled by two digital output signals from the PLC

(U621510). Default position: closed

Page 20: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 20/93

c) Alarms Following alarms can appear:

1. Main alarm 399 CONTAINER TILTING SPEED (S621580) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 399-2 CONTAINER SPEED NOT REACHED if the speed is not reached after a delay time

Page 21: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 21/93

3.4.2 Safety chain/door G620010

a) Usage / Function

The safety chain is used as a barrier of the area around the container mixer.

With closed safety chain it is possible to lift, lower or blend the container.

b) Controlling

• G620010 limit switch: - DIN: Limit switch G620010 indicates with a digital input signal to the PLC

(G620010) if the safety chain/door has been closed. After opening of the safety chain/door while recipe running or manual functions are executed the container is slowed down within 2 s.

c) Alarms

Following alarms can appear:

1. Main alarm 412 SAFETY CHAIN/DOOR (G620010) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 412-1 FEEDBACK SIGNAL FAULT: CLOSED: In case of a wrong feedback signal from the sensor an alarm will be generated.

Page 22: Functional Specification (FS) - · PDF file3.4.3 Locking cylinders Y621650 / Y621700 ... 5 System Access/Password Handling ... The information for this document is based on the order

Customer: Teva Pharmaceuticals Ind. Ltd, Israel Qualification Document

Unit: CM 2500 Functional Specification (FS)

Project: 11454 Version: 1.01

11454-FS-cc01-0101.docx Date: 08. Mar. 2011 Page 22/93

3.4.3 Locking cylinders Y621650 / Y621700

a) Usage / Function

The locking cylinder Y621650 is used to have the bracket accurately in horizontal position for dispensing.

The locking cylinder Y621700 is used to have the container in vertical position af-ter blending for undocking.

b) Controlling

• Y621650 locking cylinder: - DOT: The cylinder will be activated with a digital output signal (U621650) if it

has to be retracted. • G621660 limit switch:

- DIN: Limit switch G621660 indicates a digital input signal to the PLC (G621660) if the bracket stops at the interlock in horizontal position.

• Y621700 locking cylinder: - DOT: The cylinder will be activated with a digital output signal (U621700) if it

has to be retracted. • G621710 limit switch:

- DIN: Limit switch G621710 indicates a digital input signal to the PLC (G621710) if the bracket stops at the interlock in vertical position.

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c) Alarms Following alarms can appear:

1. Main alarm 413 HORIZONTAL POSITION (Y621650) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 413-1 FEEDBACK SIGNAL FAULT: REACHED In case of a wrong feedback signal from the sensor an alarm will be generated.

2. Main alarm 414 HORIZONTAL POSITION (Y621700) occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 414-1 FEEDBACK SIGNAL FAULT: REACHED In case of a wrong feedback signal from the sensor an alarm will be generated.

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3.5 Bracket (H621800)

a) Usage / Function The bracket clamps the container. It consists of the fixed part, the movable part, the pneumatic valves, valves and sensors and devices for fastening the container.

b) Controlling

• P621810 pressure sensor: - DIN: The pressure sensor P621810 indicates with a digital input to the PLC

(P621810) if the container is at place inside the bracket. • P621880 pressure sensor:

- DIN: The pressure sensor P621880 indicates with a digital input to the PLC (P621880) if the container is clamped.

• P621900 pressure sensor: - DIN: The pressure sensor P621900 indicates with a digital input to the PLC

(P621900) if the container is locked. • P622350 pressure sensor:

- DIN: The pressure sensor P622350 indicates with a digital input to the PLC (P622350) if the clamping pressure is ok.

• Y622300/Y622301/Y622302/Y622303 Y622304/Y622305/Y622306/Y622307 clamping cylinders: - DOT: The clamping cylinders will be clamped and released each by a digital

output signal from the PLC (U622300). • P622360 pressure sensor:

- DIN: The pressure sensor P622360 indicates with a digital input to the PLC (P622360) if the release pressure is ok.

• P622430 pressure sensor: - DIN: The pressure sensor P622430 indicates with a digital input to the PLC

(P622430) if the clamping cylinders are unlocked (detected by the measured pressure).

• Y622410/Y622411 locking cylinders: - DOT: The locking cylinders Y622410/Y622411 to release the safe locking will

be controlled by a digital output signal from the PLC (U622410).

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c) Alarms Following alarms can appear:

1. Main alarm 416 CONTAINER (G621810) occurs as soon as one of the fol-lowing sub-alarms appears:

1.1. Alarm 416-1 FEEDBACK SIGNAL FAULT: AT PLACE In case of a wrong feedback signal from the pressure sensor P621810 an alarm will be generated.

1.2. Alarm 416-2 FEEDBACK SIGNAL FAULT: CLAMPED AND LOCKED In case of a wrong feedback signal from the pressure sensor P621880 an alarm will be generated.

2. Main alarm 417 CLAMPING occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 417-1 FEEDBACK SIGNAL FAULT: CLAMPED in case of wrong or missing feedback signal from the pressure sensor P622350

2.2. Alarm 417-2 FEEDBACK SIGNAL FAULT: RELEASED in case of wrong or missing feedback signal from the pressure sensor P622360

3. Main alarm 418 CLAMPING UNLOCK occurs as soon as one of the following sub-alarms appears:

3.1. Alarm 418-1 FEEDBACK SIGNAL FAULT: UNLOCKED OK in case of wrong or missing feedback signal from the pressure sensor P622430

3.2. Alarm 418-2 FEEDBACK SIGNAL FAULT: RELEASED in case of wrong or missing feedback signal from the pressure sensor P621900

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3.6 Inertisation system

a) Usage / Function The inertisation system is used to purge the container with nitrogen before product is charged into the container.

The following main components are included:

• V164100 stop valve inert gas accessories

• V164250 inert gas valve

• V164360 pressure control valve inert gas

• P164370 pressure control inert gas

• V164390 throttle inert gas

• F164040 flow guard

• F164300 filter inert gas

• P164380 pressure inert gas >min

• V164270 pressure relief valve

• V164350 valve inert gas

• V164400 exhaust valve inert gas

• F164041 flow guard

• V164401 exhaust valve inert gas

• interface output signal "inertisation active" (DOT)

• interface input signal " Teva exhaust gas suction active " (DIN)

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b) Controlling

• V164100 stop valve inert gas accessories: manual controlled valve, not connected to the PLC

• V164250 valve inert gas: - DOT: The opening of the inert gas valve will be executed by a digital output

signal from PLC (U164250). • P164370 pressure control inert gas controller: The pressure controller keeps a constant pressure of the inert gas, by controlling the V164250 inert gas valve. Not controlled by the PLC.

• F164040 flow guard: - AIN: The inert gas flow is measured with the F164040 flow guard and read

with an analogue input signal to the PLC. • P164380 pressure inert gas > min:

- DIN: The pressure of the inert gas is monitored with the P164380 pressure inert gas >min switch and read with a digital input signal to the PLC.

• V164350 valve inert gas: - DOT: The opening of the inert gas valve will be executed by a digital output

signal from PLC (U164350). - DIN: The open and closed position of the V164350 will be monitored with lim-

it switches, each with a digital input signal to the PLC (G164340). • G620580, G620581 limit switches:

- DIN: Limit switches G620580, G620581 indicate with digital input signals (DIN) to the PLC (G620580, G620581) to stop the hydraulic pump and stop hereby the lifting the container to avoid damages at ceiling, if one of them will be activated.

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• V164400 exhaust valve inert gas: - DOT: The opening of the exhaust valve inert gas will be executed by a digital

output signal from PLC (U164400). - DIN: The open and closed position of the V164400 will be monitored with lim-

it switches, each with a digital input signal to the PLC (G164410). • F164041 flow guard (exhaust):

- AIN: The inert gas flow (exhaust) is measured with the F164041 flow guard (exhaust) and read with an analogue input signal to the PLC.

- DIN: Impulses for a predefined standard quantity/impulse to calculate the N2 quantity that has passed the container.

• V164100 stop valve inert gas accessories: manual controlled valve, not connected to the PLC

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c) Alarms Following alarms can appear:

1. Main alarm 432 VALVE INERT GAS (V164350) occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 432-1 FEEDBACK SIGNAL FAULT: OPENED In case of a wrong feedback signal from the limit switch G164350 an alarm will be generated.

1.2. Alarm 432-2 FEEDBACK SIGNAL FAULT: CLOSED In case of a wrong feedback signal from the limit switch G164350, an alarm will be gener-ated.

1.3. Alarm 432-7 FEEDBACK SIGNAL FAULT: CONNECTED, in case of plug not connected to container lid.

2. Main alarm 433 VALVE INERT GAS (V164400) occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 433-1 FEEDBACK SIGNAL FAULT: OPENED In case of a wrong feedback signal from the limit switch G164410, an alarm will be gener-ated.

2.2. Alarm 433-2 FEEDBACK SIGNAL FAULT: CLOSED In case of a wrong feedback signal from the limit switch G164410, an alarm will be gener-ated.

2.3. Alarm 433-7 FEEDBACK SIGNAL FAULT: CONNECTED, in case of plug not connected to container lid.

3. Main alarm 424 DISPENSING STOPPER occurs as soon as one of the fol-lowing sub-alarms appears:

3.1. Alarm 424-1 FEEDBACK SIGNAL FAULT: LIMIT SWITCH G620580 In case of a wrong feedback signal from the limit switch G620580 an alarm will be generated.

3.2. Alarm 424-2 FEEDBACK SIGNAL FAULT: LIMIT SWITCH G620581 In case of a wrong feedback signal from the limit switch G620581 an alarm will be generated.

4. Main alarm 427 INLET INERT GAS FLOW SENSOR (F164040) occurs as soon as one of the following sub-alarms appear:

4.1. Alarm 427-1 ACTUAL VALUE < MIN in case of inerting is active and the actual value is < min.

4.2. Alarm 427-2 ACTUAL VALUE < MINMIN in case of inerting is active and the actual flow is not ok from digital switch (DIN).

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4.3. Alarm 427-7 BROKEN WIRE in case of a broken wire detection.

5. Main alarm 428 EXHAUST INERT GAS FLOW SENSOR (F164041) occurs as soon as one of the following sub-alarms appear:

5.1. Alarm 428-1 ACTUAL VALUE < MIN in case of inerting is active and the actual value is < min.

5.2. Alarm 428-7 BROKEN WIRE in case of a broken wire detection.

6. Main alarm 429 INERT GAS DIFFERENTIAL FLOW (F164040-F164041) oc-curs as soon as one of the following sub-alarms appears:

6.1. Alarm 429-3 ACTUAL VALUE > MAX, in case of control enabled and during inertisation the differential flow is > max.

7. Main alarm 430 INERT GAS PRESSURE (P164380) occurs as soon as one of the following sub-alarms appears:

7.1. Alarm 430-1 ACTUAL VALUE < MIN, in case of control enabled and during inertisation the inlet gas pressure is < min.

8. Main alarm 438 PROCESS occurs as soon as one of the following sub alarms appears:

8.1. Alarm 438-1 CONTAINER NOT INERTED in case.

9. Main alarm 439 EXHAUST SUCTION occurs as soon as one of the following sub alarms appears:

9.1. Alarm 439-1 SIGNAL FAULT ON in case of output signal "inertisation active" is sent to the suction device (which is sent if inertisation is active and not finished) and feedback signal "Teva exhaust gas suction active" is received after a delay time.

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3.7 Operator Interface Terminal (OIT)

a) Usage / Function The operator interface (OIT) is based on a standard PC screen integrated in a stainless steel housing with keyboard, mouse, additional discrete push buttons alarm horn and lamps.

The operator interacts with the equipment by using the mouse and keyboard or the push buttons for e.g. controlling the recipe, entering process values, opening flow screens and starting machine functions.

The OIT is equipped with several push, for activate machine functions. A special button is the inching mode button. This button is for activating a software function as long as the inching mode button is pressed.

The operating panel comprises:

- Stainless steel housing

- Industrial colour monitor TFT

- Emergency stop switch

- Acoustic alarm horn

- Lamps indicating machine status

- Control on / off

- Manual / maintenance mode

- inching mode

- emergency stop / horn reset

b) Controlling

• If the green lamp "Ready for control on" is illuminated, then control can be turned on.

• the alarms will only be indicated, when control is turned on

• Machine functions can only be turned on if control is enabled

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c) Alarms Following alarms can appear:

1. Main alarm 164 SUPPLY 1 occurs as soon as one of the following sub-alarms appears:

1.1. Alarm 164-6 VOLTAGE L+C NOT OK in case of a wrong feedback sig-nal from the L+C voltage.

1.2. Alarm 164-7 VOLTAGE L+E NOT OK in case of a wrong feedback sig-nal from the L+E voltage.

2. Main alarm 165 SUPPLY 2 occurs as soon as one of the following sub-alarms appears:

2.1. Alarm 165-1 EMERGENCY STOP ACTIVATED: If Emergency Stop is activated.

3. Main alarm 166 COMMUNICATION occurs as soon as one of the following sub-alarms appears:

3.1. Alarm 166-1 NO COMMUNICATION BETWEEN PLC AND PC in case of communication error between PC and PLC.

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4 Function oriented description

4.1 Control On/Off

a) Operating

Control is turned on/off with a push button (ON/OFF) at the OIT.

b) Interlocks Control can be turned on (ready for control on), if:

• main power supply on

• emergency stop not activated

Control is enabled, if:

• status "ready for control on" present

• Control is turned on

• shut down level 1 not active

c) Machine parameter NA

d) Activated parts

• contactor control on activated

• pilot lamp "ready for control on" activated

• pilot lamp "control on" activated

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4.2 Hydraulic On/Off

a) Operating The hydraulic system supplies the hydraulic equipment for lifting/lowering and for blending with driving power.

It is switched on automatically if it is required for one of the operations which use hydraulic driving power. After executing a function the hydraulic system remains active with standby pressure and flow. After a time-out has expired where no hy-draulic driving power was needed, the hydraulic system switches automatically off.

b) Interlocks

Hydraulic is automatically switched on if:

• control enabled

• lifting/lowering operation started

• blending/tilting to interlock operation started

• shutdown 2 not active

• standby time not elapsed

c) Machine parameter

NA

d) Activated parts

• PM623500 hydraulic unit

• V623660 cold water valve

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4.3 Manual Inertisation On/Off

a) Operating The function Manual Inerting can be started if a container is in dispensing position (G620580/81) for inerting the container.

b) Interlocks Manual Inertisation can be switched on if:

• control enabled

• container in dispensing position

• revision mode off

• Main alarm 424 DISPENSING STOPPER not active

• Alarm 427-7 BROKEN WIRE, from the INLET INERT GAS FLOW SENSOR (F164040) not active

• Alarm 428-7 BROKEN WIRE, from EXHAUST INERT GAS FLOW SENSOR (F164041) not active

• Inerting hoses INSTALLED, confirmed by software button

• CT flap IS OPEN, confirmed by software button

• Valves V164350 and V164400 are connected (monitored by DIN)

• Source station discharge flap is closed, confirmed by software button

• Alarm 439-1 EXCHAUST SUCTION - SIGNAL FAULT ON not active

Manual Inerting can always switch off.

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c) Machine parameter Machine Parameter

Set

poin

t

Act

ual

Val

ue Unit

Inerting Quantity Outlet x x l

d) Activated parts (only active when signal "TEVA EXHAUST GAS SUCTION ACTIVE" is present)

• V164250 inert gas valve

• V164350 valve inert gas

• V164400 exhaust valve inert gas

• V164401 exhaust valve inert gas

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4.4 Revision Mode On/Off

a) Operating For functional testing a revision mode will be implemented which can be activated by key switch.

The requested function has to be pre-selected by software buttons on the OIT. The selected function is executed as long as the push button "Action" is pressed (inching mode).

Following functions can be activated in revision mode:

• lifting / lowering

• tilting CW / tilting CCW

• blending latch retract/protract

• catch latch retract/protract

• Inertisation valves (without the support valve) open/close

Following valves can be activated in revision mode:

• Y621150 height stop device

• Y621650 latch horizontal

• Y621700 latch horizontal tilt

• V621020 hydraulic valve, indirect activatable

• V621510 hydraulic valve, indirect activatable

• V164350 valve inert gas

• V164400 exhaust valve inert gas

• V164401 exhaust valve inert gas

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b) Interlocks Turning revision mode on is only possible if:

• control enabled

• CM recipe not loaded

• manual mode by key switch selected "on"

• move to docking position 0 off

• move to docking position 1 off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to clamping position off

• move to latch position off

• clamping / release container off

• Inertisation not active

Turning revision mode off is only possible if:

• control enabled

• no manual functions activated

• manual mode by key switch selected "off"

• all valves in basic position

c) Machine parameter NA

d) Activated parts

• selected functions

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4.4.1 Manual Lifting/Lowering On/Off

a) Operating

In this function the carriage with or without the docked container will be lifted or lowered while pressing the push button “Action” (Inching-Mode).

Pre-selection of Lifting via software button "Lift" on the OIT.

Pre-selection of Lowering via software button "Lower" on the OIT.

Reset of lifting/lowering via software button "Stop" on the OIT.

b) Interlocks

manual lifting is only possible if:

• control enabled

• Revision mode on

• highest position not reached (G620500)

• calibration move off

• shutdown level 2 not active

manual lowering is only possible if:

• control enabled

• Revision mode on

• docking latch not reached (G620940)

• calibration move off

• shutdown level 2 not active

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lifting is finished if:

• highest position reached (G620500)

• push button "Action" not pressed (Inching-Mode)

lowering is finished if:

• docking latch reached (G620940)

• push button "Action" not pressed (Inching-Mode)

c) Machine parameter

NA

d) Activated parts

• Y621010 hydraulic lifting device

• V621020 hydraulic valve

• P623500 hydraulic pump

• V623660 cold water valve by hydraulic pump

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4.4.2 Manual Tilting CW/Tilting CCW On/Off

a) Operating

In this function the carriage with or without the docked container will be tilted in CW direction or CCW direction while pressing the push button “Action” (Inching-Mode).

Pre-selection of Tilting CW via software button "Tilt CW" on the OIT.

Pre-selection of Tilting CCW via software button "Tilt CCW" on the OIT.

Reset of tilting via software button "Stop" on the OIT.

b) Interlocks manual tilting CW direction is only possible if:

• control enabled

• Revision mode on

• calibration move off

• container is out or clamped

• shutdown level 2 not active

• carriage/container in blending position

manual tilting CCW direction is only possible if:

• control enabled

• Revision mode on

• calibration move off

• container is out or clamped

• shutdown level 2 not active

• carriage/container in blending position

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tilting CW is finished if:

• push button "Action" not pressed (Inching-Mode)

tilting CCW is finished if:

• push button "Action" not pressed (Inching-Mode)

c) Machine parameter

NA

d) Activated parts

• Y621540 hydraulic motor

• Y621541 hydraulic motor

• V621510 hydraulic valve

• P623500 hydraulic pump

• V623660 cold water valve by hydraulic pump

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4.4.3 Manual latch horizontal position retract/protract

a) Operating

In this function the catch latch will be retracted/protracted by clicking on the cor-responding symbol in the flow diagram. Then a pop-up window appears with a se-lection to close or to open the latch.

b) Interlocks retracting/protracting the manual latch is only possible if:

• control enabled

• Revision mode on

c) Machine parameter NA

d) Activated parts

• Y621650 locking cylinder (horizontal position)

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4.4.4 Manual latch vertical position retract/protract

a) Operating

In this function the catch latch will be retracted/protracted by clicking on the cor-responding symbol in the flow diagram. Then a pop-up window appears with a se-lection to close or to open the latch.

b) Interlocks retracting/protracting the manual latch is only possible if:

• control enabled

• Revision mode on

c) Machine parameter NA

d) Activated parts

• Y621700 locking cylinder (vertical position)

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4.5 Clamping activate/release

a) Operating In this function the clamping device will be activated/released via software buttons "Clamping activate" and "Clamping release" on the OIT.

b) Interlocks clamping is only possible if:

• control enabled

• CM process not active

• Revision mode off

• container at place (P621810)

• clamping position reached

• no shutdown 2 alarm active

• move to docking position 0 off

• move to docking position 1 off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to clamping position off

• move to latch position off

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release is only possible if:

• control enabled

• CM process not active

• Revision mode off

• container at place (P621810)

• clamping position reached

• no shutdown 2 alarm active

• move to docking position 0 off

• move to docking position 1 off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to clamping position off

• move to latch position off

• container in horizontal position

c) Machine parameter NA

d) Activated parts

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder

• Y622410/Y622411 locking cylinder

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4.6 Move to clamping position

a) Operating This function will be executed via software buttons on the OIT.

In this operation the bracket will be moved to the intermediate position for clamp-ing.

b) Interlocks move to clamping position is only possible if:

• control enabled

• CM process not active

• safety chain/door closed

• shutdown 2 alarm not active

• revision mode off

• container in a defined position

• move to docking position 0 off

• move to docking position 1 off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to latch position off

• inertisation not active

• harding plug of V164350 not connected confirmed that:

• inertisation hoses not installed

• confirmed that container flap is closed

move to clamping position is finished if:

• control not enabled or G620540 position clamping latch loaded

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c) Machine parameter NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y621150 height stop device

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Unit: CM 2500 Functional Specification (FS)

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4.7 Move to blending position

a) Operating This function will be executed via software buttons on the OIT.

In this operation the bracket with the clamped container will be moved to the latch position for blending.

If the container is not clamped, he will be automatically clamped before the bracket moves.

b) Interlocks

move to blending position is only possible if:

• control enabled

• CM process not active

• Revision mode off

• container at place

• safety chain/door closed

• shutdown 2 alarm not active

• container in a defined position (docking, clamping or dispensing position)

• move to docking position 0 off

• move to docking position 1 off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to clamping position off

• move to latch position off

• bracket in horizontal position (G621660 or G621710)

• inertisation not active

• harding plug of V164350 not connected

• confirmed that the inertisation hose is not installed

• confirmed that the container flap is closed

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move to blending latch position is finished if:

• control not enabled

• G621180 position latch loaded

• correct actual height set value reached

c) Machine parameter NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder (if the container was not clamped before)

• Y622410/Y622411 locking cylinder (if the container was not clamped before)

• Y621150 height stop device

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4.8 Move to dispensing position (1000)

a) Operating This function will be executed via software buttons on the OIT.

In this operation the bracket with the clamped container will be moved to the dis-pensing position 2 for adding lubricates.

When the position is reached the function is stopped.

If the container is not clamped, he will be automatically clamped at clamping posi-tion before the bracket moves.

b) Interlocks

move to dispensing position is only possible if:

• control enabled

• CM process not active

• Revision mode off

• small container at place

• safety chain/door closed

• shutdown 2 alarm not active

• container in a defined position (docking or blending position)

• move to docking position 0 off

• move to docking position 1 off

• move to blending position off

• move to clamping position off

• move to latch position off

• bracket in horizontal position (G621660) or blending position

• harding plug of V164350 not connected

• confirmed that the inertisation hose is not installed

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move to blending latch position is finished if:

• control not enabled or dispensing position 2 (1000) reached and Limit switch G621180

c) Machine parameter

NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder (if the container was not clamped before)

• Y622410/Y622411 locking cylinder (if the container was not clamped before)

• Y621150 height stop device

• V621510 hydraulic valve

• Y621700 locking cylinder

• Y621650 locking cylinder

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4.9 Move to dispensing position (2500).

a) Operating This function will be executed via software buttons on the OIT.

In this operation the bracket with the clamped container will be moved to the dis-pensing position 1 for adding lubricates.

When the position is reached the function is stopped.

If the container is not clamped, he will be automatically clamped at clamping posi-tion before the bracket moves.

b) Interlocks

Move to dispensing position is only possible if:

• control enabled

• CM process not active

• Revision mode off

• big container at place

• safety chain/door closed

• shutdown 2 alarm not active

• container in a defined position (docking or blending position)

• move to docking position 0 off

• move to docking position 1 off

• move to blending position off

• move to clamping position off

• move to latch position off

• bracket in horizontal position (G621660) or blending position

• harding plug of V164350 not connected

• confirmed that the inertisation hose is not installed

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move to blending latch position is finished if:

• control not enabled or dispensing position 1 (2500) reached and Limit switch G621180

c) Machine parameter

NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder (if the container was not clamped before)

• Y622410/Y622411 locking cylinder (if the container was not clamped before)

• Y621150 height stop device

• V621510 hydraulic valve

• Y621700 locking cylinder

• Y621650 locking cylinder

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4.10 Move to docking position (1000)

a) Operating This function will be executed via software buttons on the OIT.

In this operation the bracket will be moved to the docking position.

The container will be automatically unclamped if he was clamped before.

b) Interlocks

move to docking position is only possible if:

• control enabled

• CM process not active

• bracket in horizontal position (G621660 or G621710) or in blending position

• safety chain/door closed

• shutdown 2 alarm not active

• no container or small container at place

• revision mode off

• container in a defined position (docking 2500, blending, clamping, dispensing position 1000)

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to clamping position off

• move to latch position off

• move to docking position 2500 off

• inertisation not active

• harding plug of V164350 not connected

• confirmed that the inertisation hose is not installed

• confirmed that the container flap is closed

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move to docking position is finished if:

• control not enabled or G620940 position low latch reached

c) Machine parameter

NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y620700 blending latch retracted

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder (if the container was clamped before)

• Y622410/Y622411 locking cylinder (if the container was clamped before)

• Y621150 height stop device (if the container was in dispensing position)

• V621510 hydraulic valve (if the container was in dispensing position)

• Y621700 locking cylinder (if the container was in dispensing position)

• Y621650 locking cylinder (if the container was in dispensing position)

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4.11 Move to docking position (2500)

a) Operating This function will be executed via software buttons on the OIT.

In this operation the bracket will be moved to the docking position.

The container will be automatically unclamped if he was clamped before.

b) Interlocks

move to docking position is only possible if:

• control enabled

• CM process not active

• bracket in horizontal position or in blending position

• safety chain/door closed

• shutdown 2 alarm not active

• no container or big container at place

• revision mode off

• container in a defined position (clamping, docking 1000, blending, dispensing 2500)

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to clamping position off

• move to latch position off

• move to docking position 1000 off

• inertisation not active

• harding plug of V164350 not connected

• confirmed that the inertisation hose is not connected

• confirmed that the container flap is closed

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move to docking position is finished if:

• control not enabled or docking height 2500 is reached

c) Machine parameter

NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y620700 blending latch retracted

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder (if the container was clamped before)

• Y622410/Y622411 locking cylinder (if the container was clamped before)

• Y621150 height stop device (if the container was in dispensing position)

• V621510 hydraulic valve (if the container was in dispensing position)

• Y621700 locking cylinder (if the container was in dispensing position)

• Y621650 locking cylinder (if the container was in dispensing position)

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4.12 Calibration Move

a) Operating This function will be executed via software buttons on the OIT.

This function is used to reach the defined setpoints for the different height posi-tions.

b) Interlocks calibration move is only possible if:

• control enabled

• revision mode on

• safety chain / door closed

• process not started

• no lifting/lowering in revision activated

• blending in revision not active

• G620940 lowest position reached

• Y621150 revision not activated

• container not at place

calibration move is finished if:

• control not enabled

• all positions once reached: docking position (2500) blending position clamping position dispensing position 1 (1000) dispensing position 2 (2500) carriage moved back to lowest position

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c) Machine parameter NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y621150 height stop device

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4.13 Move to latch position

a) Operating This function will be executed via software buttons on the OIT.

This function is used to reach a latch from an undefined position and it goes al-ways to the next lower position.

b) Interlocks move to latch position is only possible if:

• control enabled

• CM process not active

• Revision mode off

• safety chain/door closed

• shutdown 2 alarm not active

• move to docking position 0 off

• move to docking position 1 off

• move to blending position off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to clamping position off

move to latch position is finished if:

• control not enabled or next lowest position reached

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c) Machine parameter NA

d) Activated parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

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4.14 Batch

4.14.1 Batch open

For running a recipe a batch has to be open by selecting the “start batch” function in the menu. Following information has to be entered for opening a batch:

• selection of the recipe

• enter batch number

• selection Bin size

source con-tainer

possible destination container CS1000 CS2500

0 x -

1 - x

Due to the bin size pre-selection the min inerting quantity is fixed. After confirmation the batch will be opened and the recipe will be loaded. When the batch is opened, all coming and going alarms and changes of setpoints will be linked to the batch report data inside batch tables of the SQL Database. The batch data will be stored electronically and can be printed by the operator.

4.14.2 Batch close

The batch can be closed if the recipe is finished or canceled.

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4.14.3 Batch report/ Batch record retention

The batch report will be created out of the Batch tables of the SQL Database. To create the batch report the Glatt application “ReportView” is used. The report is not printed out automatically at the end of the process. It can be printed out at any time but will be complete only when the batch is closed. If batch numbers are used twice, the operator is prompted to confirm that he want to open a new sub batch. After confirmation the data of the new batch will be added to the data of the previous batch with the same batch number. Existing data will not be deleted. The batch report contains following data: Batch Report Header:

• Process Type

• Batch Number

• Batch Start User

• Start Date/Time

• End Date/Time

• Customer ID "Machine ID (TEVA ID.)" Info sheet:

• Catalogue No.

• Product Name

• Recipe version

• BOP name

• blank lines to fill in date and signature (for Operator and Supervisor)

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4.15 Recipe-Manager

Each recipe of every machine is a sequence of basic operations which will be worked through by the control system. Each basic operation (BOP) has a set of typical setpoints (see next chapters). To oper-ate the process with its setpoints a so called recipe-manager "MegaBatch" is running on the PC. This window allows running, holding, stopping or ending the recipe, to look at and to modify the actual setpoints of the basic operation. For each recipe the user can define the used basic operations with its setpoints. The following basic operations and recipe types are available:

Recipe type Basic Operations CM Blending

Dispensing

Finish

Before creating, renaming, editing, copying or enabling a recipe the operator has to se-lect to which type of process the recipe belongs. After selecting the process type only the recipes belonging to this type of process are displayed and can be selected.

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4.15.1 Create recipe

To create a recipe it must be defined for which recipe type the recipe should be availa-ble. The following information has to be entered in the recipe:

• Catalogue no.

• recipe description

• Selection of Basic Operations used for this recipe

4.15.2 Trippoint

The trippoints allow jumping from a BOP to another BOP within the recipe.

Recipe

BOP

BOP

Trippoint

Following trippoints are available:

• blending finished

• position reached

.

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4.15.3 Recipe status

The recipe can have different status. Depending on user-operation and machine state the recipe status changes: Status Description

RECIPE LOADED

As soon as a batch is open the selected recipe is loaded and the state of the process is RECIPE LOADED

RUN If the state of the process is RECIPE LOADED, the BOP can be started and set into status RUN with the START-key.

HOLD The state of the process changes from RUN to HOLD per operator function or if an interrupt appears. In hold mode the recipe runs with the safety values if defined else with the setpoint. By continuing the recipe the state changes from HOLD to RUN again. By stopping the recipe the state changes from HOLD to STOP.

STOP If the state is HOLD or RUN and the operator stops the process or if an interrupt appears, the state of the process changes to STOP. The batch is still open but the process is stopped. In this case the operator can either continue the process activate the HOLD mode or end the recipe.

END The recipe is finished when the operator presses the End-key in STOP mode (Process is aborted) or if the process is automatically finished. The batch can only be closed when the recipe is finished.

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open the batch menu and select recipe and batch

number

Data accepted ?

Userguide

No

Batch open and recipe loaded

Yes

RUN mode: Recipe is running

processready for

operation ?

Userguide

Yes

No

STOP mode HOLD mode

hold valuedefined ?

Recipe hold with setpoint

value

Recipe hold with hold

value

No Yes

auto finish(e.g macro

abort) ?

No

automatic hold ?

No

END mode:Recipe finished

Yes

Yes

finish

(no air flow and all flaps are closed)

Megabatch

BatchOpenWizzard

Batch closed

batch endBatchCloseWizzard

Diagram of recipe status

automatic hold ?

Yes

No

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4.15.4 Recipe in automatic mode

In recipe mode "automatic", the process jumps automatically into an other BOP accord-ing to the trippoint logic defined for the current basic operation. (see chapter 4.15.2 Trippoint). It is always possible to switch to manual mode and change to another BOP.

4.15.5 Recipe in manual mode

Manual mode means that: The actual wanted BOP can be selected with the function keys "BOP forward" and "BOP backward" by the operator. All trippoints are disabled; current BOP of the recipe will not be defined by trippoints but by the operator selecting the wanted BOP pressing the function keys "BOP forward“ or "BOP backward“. Jumping to the next BOP is not possible, as long as one BOP is ac-tive. Run, stop or end of BOP will be selected by operator manually. Each intervention is reported inside the batch-report. Complete recipe can be operated with this manual function. The interlocks from recipe automatic are still valid in recipe manual mode. This means, the recipe will stay in the actual BOP.

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4.15.6 Start CM Recipe

a) Operating

CM recipe can be started by a mouse click on the softkey in the recipe control box when a CM batch is open.

It is possible to run the recipe in semi-automatic or automatic mode.

The recipe can be interrupted at any time. When continuing the recipe after an in-terruption, the recipe runs from the point where it was stopped. When switching the recipe off (end), a new recipe runs from the beginning.

After an emergency stop during blending is running the container is driven down in a ramp within 2 s.

After opening of the safety chain/door during blending is running the container is also driven down in a ramp within 2 s.

b) Interlocks

Start of a CM recipe is only possible if “CM recipe ready for start“:

• control enabled

• bracket in docking height

• safety chain closed

• shutdown 2 not active

• revision mode off

• container at place

• move to docking position 0 off

• move to docking position 1 off

• move to dispensing position 1 off

• move to dispensing position 2 off

• move to blending position off

• move to latch position off

• move to clamping position off

c) activated parts / machine parameter / recipe parameter When the recipe is running the activated parts / machine parameter / recipe para-meter depend on the BOP. For this, see section 4.15.8.1 - 4.15.8.3.

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4.15.7 Basic operation (BOP)

A BOP is defined with:

• a BOP name

• a BOP description

• a list of recipe parameters used for this operation

• recipe types for which the BOP is assigned to

The following basic operations and recipe types are available: Recipe type Basic Operations

CM Blending

Dispensing

Finish

For each parameter the following values can be defined:

• Setpoint

4.15.7.1 Setpoint The setpoints are used when the recipe is running. Setpoints are defined in the BOP but can be changed by editing the recipe.

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4.15.8 Types of BOP for CM recipe

4.15.8.1 Basic Operation Blending a) Operating

Automatic, when recipe is started.

During this BOP the container is moved into the bracket by transport device.

After the pressure sensor P621810 has signalized that "container at place", the container will be moved to intermediate position.

Clamping will be started by activating the clamping cylinder and after this the lock-ing cylinder.

The signal “Container clamped and locked” allows lifting/lowering and blending of the bracket with the docked container.

For blending the blending latch is loaded and the container is accelerated up to pre-selected speed in CW direction.

If this speed is reached then blending time will be started. If this time is finished then the container will be tilted in CCW direction until the horizontal position is reached (necessary for following lifting or lowering).

After this the BOP will be switched to the next one from the position of the blend-ing latch.

b) Interlocks

Start BOP Blending is only possible:

• recipe ready for start

• blending position or docking position

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c) Recipe Parameter Recipe Parameter

Set

poin

t

Min

Max

Set

tling

tim

e

dela

y tim

e m

in

dela

y tim

e m

ax

Unit

blending time x - - - - - min

blending speed x - - - - - rpm

Inertisation required x - - - - - yes/no

d) Activated Parts

• V623660 cold water valve by hydraulic pump

• P623500 hydraulic pump

• V621020 hydraulic valve

• Y621010 hydraulic lifting device

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder

• Y622410/Y622411 locking cylinder

• Y621540 hydraulic motor

• Y621541 hydraulic motor

• P623500 hydraulic pump

• V621510 hydraulic valve

• Y621650 catch latch

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4.15.8.2 Basic Operation Dispensing a) Operating

Automatic, when it is reached during a recipe.

During this BOP product can be added into the container.

Following steps will be executed during adding:

• lifting and clamping, if starting from the docking position

• Inverting of container

• Lifting of container up to the dispensing position Container inertisation, parameter "Inerting" is set to YES in recipe. Inertisation has to be started manually by the operator because the container has to be prepared manually in advance.

• Inertisation

‐ Manual preparation: open CT flap manually (confirmed by SW button) connect Harding plugs (checked by DIN) connect inerting hoses (confirmed by SW button) close discharging tube in upper floor (dispensing flap or s.e.) (confirmed by SW button)

• Inertisation sequence

‐ Open exhaust air section for inerting ‐ Open inlet air section for inerting ‐ setpoint "inerting quantity" reached ‐ Close inlet air section for inerting ‐ Close exhaust air section for inerting ‐ "Blender Ready" for charging

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• Container charging with product

• Charging ‐ Blender ready for charging ‐ Container charged by external CDS (by operator) ‐ preparing the container for undocking after finishing with charging ‐ Close container flap (by operator) ‐ Disconnect inert gas supply (by operator) ‐ close source station discharging flap (by operator) ‐ disconnect Harding plug to V164350 (by operator)

confirmation by operator that dispensing is finished and container can be undocked and lowered

• Lowering of container

• turning back to horizontal/ normal position

b) Interlocks

Start BOP Dispensing is only possible:

• recipe ready for start

• horizontal/ normal position reached

• blending height reached or from docking position

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c) Recipe Parameter Recipe Parameter

Set

poin

t

Min

Max

Set

tling

tim

e

dela

y tim

e m

in

dela

y tim

e m

ax

Unit

Container Inertisation (yes/no) x - - - - - -

d) Activated Parts

• V621020 hydraulic valve

• P623500 hydraulic pump

• V621510 hydraulic valve rotating/blending

• Y621540 hydraulic motor rotating/blending

• Y621541 hydraulic motor rotating/blending

• V623660 cold water valve by hydraulic pump

• Y622460/Y622461/Y622462 horizontal cylinder

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder

• Y622410/Y622411 locking cylinder

• V164250 inert gas valve, if parameter "Inertisation" is set to "yes"

• V164350 valve inert gas, if parameter "Inertisation" is set to "yes"

• V164401 exhaust valve inert gas, if parameter "Inertisation" is set to "yes"

• V164400 exhaust valve inert gas, if parameter "Inertisation" is set to "yes"

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4.15.8.3 Basic Operation Finish a) Operating

Automatic, when it is reached during a recipe. (Has to be defined as last phase of each batch)

During this BOP the container is turned to normal position, the latch Y620700 (latch blending) will be retracted and then the container is lowered to the clamping position for unclamping and afterwards lowered to the corresponding docking posi-tion.

After the bracket is opened the container is moved out of the bracket by a trans-port device.

b) Interlocks Start BOP Finish is only possible:

• always, if recipe is ready for start

• horizontal/ normal position reached

• blending height reached

c) Recipe Parameter

NA

d) activated parts

• V621020 hydraulic valve

• Y620700 blending latch

• P623500 hydraulic pump

• V623660 cold water valve by hydraulic pump

• Y621010 hydraulic lifting device

• Y622300/Y622301/Y622302/Y622303/Y622304/Y622305/Y622306/Y622307 clamping cylinder

• Y622410/Y622411 locking cylinder

• Y621150 height stop device

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5 System Access/Password Handling

Password handling will be dealt with a Glatt application called "User Manager". The individual functions are assigned to "Areas". These areas are used as interface be-tween the User Manager and the graphic screens. For each activity and access to the MegaView system, areas are defined. The assignment of levels/areas is set in graphic screens and pre-defined by Glatt. If no user is logged in no function can be executed. Minimum Password length: 6 characters (alpha-numeric)

Are

a N

o

Area Name 1

- O

pera

tor 1

2 -

Ope

rato

r 2

3 -

Prod

uctio

n S

uper

viso

r

5 -

Mai

nten

ance

6 -

Pha

rmac

ist

7 -

Gla

tt M

aint

enan

ce

8 -

Gla

tt A

dmin

istra

tor

1 Helpfiles for Megabatch enabled - - - - - X X

10 Start Machine in manual or automatic mode X X X X X X X

11 Set process to manual mode - X X X X X X

13 Load and start a released recipe X X X X X X X

14 Changing process parameters during process - X X X X X X

15 Change actual operation during process manually - X X X X X X

16 Change trip-points during process - X X - X X X

17 Adding/deleting trip-points during process - - X - X X X

18 Add annotation to batch report printout during process X X X X X X X

20 save current process parameters as a new recipe - X X - X X X

21 overwrite current recipe with current process parameters - - X - X - X

22 Create/save/change a recipe - - X - X - X

23 Rename recipe - - X - X - X

24 Copy recipe - - X - X - X

29 Preset Hold-type on each BOP inside recipe - - - - X - X

30 For single Operation: Set manual jump into another operation X X X X X X X

36 Set input ranges during process - - - - - - X

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Are

a N

o

Area Name

1 -

Ope

rato

r 1

2 -

Ope

rato

r 2

3 -

Prod

uctio

n S

uper

viso

r

5 -

Mai

nten

ance

6 -

Pha

rmac

ist

7 -

Gla

tt M

aint

enan

ce

8 -

Gla

tt A

dmin

istra

tor

37 Set trip action - - - - X - -

38 Set BOP action - - - - X - -

41 Print recipe - - X - X - X

42 Release recipe - - X - X - X

43 Authorize recipe - - - - X - X

50 Display batch report X X X X X X X

51 Print batch-reports X X X X X X X

52 Archive batch-report (move into archive) - - X - X - X

53 Retrieve batch-report (from archive) - - - - X - X

55 setup batch-reports (format and content) - - - - X - X

57 Export a batch-report X X X X X X X

59 Setup batch number (format) - - - - - - X

60 View alarm and message window X X X X X X X

61 Acknowledgement of activated alarms X X X X X X X

73 Access to service menu: PID controller - - - X - X X

74 Access to service menu: manual/auto mode selector - - - X - X X

75 Access to service menu: set machine parameters - - - X - X X

76 Access to service menu: service functions - - - X - X X

78 Access to service menu: time and date setup - - - X - X X

81 Acess to controller settings through process screen - - - X - X X

90 Display P&I-tags X X X X X X X

100 Edit BOP - - - - - - X

101 Hold batch with stop the machine - X X X X X X

102 Megabatch : Print and save screens - - - - - - X

103 Megabatch : Parameter Setup - - - - - - X

104 Megabatch : Enable/Disable Process Types - - - - - - X

105 Megabatch : Access setup - - - - - - X

106 Megabatch : Language Setup - - - - - - X

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Are

a N

o

Area Name

1 -

Ope

rato

r 1

2 -

Ope

rato

r 2

3 -

Prod

uctio

n S

uper

viso

r

5 -

Mai

nten

ance

6 -

Pha

rmac

ist

7 -

Gla

tt M

aint

enan

ce

8 -

Gla

tt A

dmin

istra

tor

110 Access to system screens/system menu - - - - - - X

114 Setup recipe editor - - - - - - X

115 Syncronize users - - X - X - X

120 Shut down computer X X X X X X X

121 Reboot computer - X X X X X X

122 Restart Megaview - - - - - - X

123 Close Megaview - - - - - - X

130 Change language for screens X X X X X X X

140 Verify alarm acknowledgement - - X - X X X

141 Verify parameter change - - X - X X X

142 Verify enable recipe - - - - X - X

143 Verify authorize recipe - - - - X - X

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6 Alarms

If an alarm occurs, a general alarm lamp and an acoustic signal will indicate the incom-ing malfunction. The alarm lamp is on until the alarm is confirmed and acknowledged by the operator. The operator is able to select an alarm message screen. At this screen all active alarms will be displayed with the corresponding plain alarm text. A complete alarm list is part of this functional specification. The alarms are divided into main alarms and sub-alarms. If an alarm occurs, the main alarm is indicated on the alarm screen. As soon as a double click is executed on the selected active alarm, then the sub alarm which has activated the main alarm is indicated. A flap with opened and closed limit switches for example will have one main alarm say-ing that the flap has a malfunction. If the double click on the main alarm is executed an additional box opens detailing the corresponding sub alarm which has activated the main alarm. In this case this can be the opened limit switch or the closed limit switch. The existing main a sub-alarms with the alarm-texts shown on the screens are listed in section 6.2.

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6.1 Alarm settling times and alarm delay times

Parameters will be monitored by the control system. Once they are leaving the MIN/MAX-tolerances an alarm will be generated. The Alarm timers will define the time between leaving the MIN/MAX tolerance and alarming.

a) Alarm Settling Time (ts) Time which prevents the activation of unwanted alarms after the initiation of a new BOP. The alarm will occur if the actual parameter value has not reached the MIN/MAX-Band after the settling time is complete. The settling time starts counting on every set-point change.

b) Alarm Delay Time (td) If the actual value of a given parameter exceeds either of the pre-defined MINIMUM/MAXIMUM limits the min delay time, respectively the max delay time, will start to count down and if the alarm state is still actual after the expiration of the corresponding delay time, an alarm will be generated.

settling timemin delay

timemin delay

time

max delaytime

alarm

no alarm

MAX

MIN

BAND

actual value

t

alarm

The alarm settling times and alarm delay times are defined in the recipe for the recipe parameters and in the alarm setting menu for the machine parameters.

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6.2 Alarms Overview

Alarm No./Text, [Shutdown level] Ref. to Page 164 SUPPLY 1 ......................................................................................................................................32 164-6 VOLTAGE L+C NOT OK, [1] ........................................................................................................32 164-7 VOLTAGE L+E NOT OK, [1] ........................................................................................................32 165 SUPPLY 2 ......................................................................................................................................32 165-1 EMERGENCY STOP ACTIVATED, [1] .........................................................................................32 166 COMMUNICATION .........................................................................................................................32 166-1 NO COMMUNICATION BETWEEN PLC AND PC, [2] ..................................................................32 167 COMPRESSED AIR SUPPLY PRESSURE (P000333)....................................................................10 167-1 ACTUAL VALUE < MIN, [1] ..........................................................................................................10 399 CONTAINER TILTING SPEED (S621580) ......................................................................................20 399-2 CONTAINER SPEED NOT REACHED, [2] ...................................................................................20 400 HYDRAULIC PUMP (P623500) .......................................................................................................13 400-1 NOT SWITCHED ON, [2] .............................................................................................................13 401 HYDRAULIC OIL (B623630) ...........................................................................................................13 401-1 PD623620 OIL FILTER DIRTY, [2] ...............................................................................................13 401-2 L623630 OIL LEVEL TOO LOW, [2] .............................................................................................13 401-3 T623610 OIL TEMPERATURE TOO HIGH, [2] .............................................................................13 402 HYDRAULIC UNIT (E623500).........................................................................................................13 402-1 MALFUNCTION, [2] .....................................................................................................................13 402-2 CONTROLLER AGGREGATE, [2] ................................................................................................13 404 HIGHEST POSITION (G620500) .....................................................................................................15 404-1 FEEDBACK SIGNAL FAULT: REACHED, [2] ...............................................................................15 405 INTERMEDIATE POSITION (G620540) ..........................................................................................15 405-1 FEEDBACK SIGNAL FAULT: REACHED, [2] ...............................................................................15 406 DOCKING POSITION (G620940) ....................................................................................................18 406-1 FEEDBACK SIGNAL FAULT: LOADED, [2] ..................................................................................18 408 HEIGHT STOP DEVICE (Y621150) .................................................................................................17 408-1 FEEDBACK SIGNAL FAULT: PIVOTED OUT, [2] ........................................................................17 408-2 FEEDBACK SIGNAL FAULT: PIVOTED IN, [2] ............................................................................17 409 DESTINATION POSITION (G620600).............................................................................................15 409-1 FEEDBACK SIGNAL FAULT: REACHED, [2] ...............................................................................15 409-7 BROKEN WIRE, [NA] ...................................................................................................................15 412 SAFETY CHAIN/DOOR (G620010) .................................................................................................21 412-1 FEEDBACK SIGNAL FAULT: CLOSED, [2] ..................................................................................21 413 HORIZONTAL POSITION (Y621650) ..............................................................................................23 413-1 FEEDBACK SIGNAL FAULT: REACHED, [2] ...............................................................................23 414 HORIZONTAL POSITION (Y621700) ..............................................................................................23 414-1 FEEDBACK SIGNAL FAULT: REACHED, [2] ...............................................................................23 416 CONTAINER (G621810) .................................................................................................................25 416-1 FEEDBACK SIGNAL FAULT: AT PLACE, [2] ...............................................................................25 416-2 FEEDBACK SIGNAL FAULT: CLAMPED AND LOCKED, [2] ........................................................25 417 CLAMPING .....................................................................................................................................25 417-1 FEEDBACK SIGNAL FAULT: CLAMPED, [2] ...............................................................................25 417-2 FEEDBACK SIGNAL FAULT: RELEASED, [2]..............................................................................25 418 CLAMPING UNLOCK .....................................................................................................................25 418-1 FEEDBACK SIGNAL FAULT: UNLOCKED OK, [2] .......................................................................25 418-2 FEEDBACK SIGNAL FAULT: RELEASED, [2]..............................................................................25 419 HEIGHT STOP DEVICE (G621180) ................................................................................................17 419-1 FEEDBACK SIGNAL FAULT: SIGNAL LOST, [2] .........................................................................17 424 DISPENSING STOPPER ................................................................................................................29

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424-1 FEEDBACK SIGNAL FAULT: LIMIT SWITCH G620580, [2] .........................................................29 424-2 FEEDBACK SIGNAL FAULT: LIMIT SWITCH G620581, [2] .........................................................29 427 INLET INERT GAS FLOW SENSOR (F164040)..............................................................................29 427-1 ACTUAL VALUE < MIN, [NA] .......................................................................................................29 427-2 ACTUAL VALUE < MINMIN, [NA] .................................................................................................29 427-7 BROKEN WIRE, [NA] ...................................................................................................................30 428 EXHAUST INERT GAS FLOW SENSOR (F164041) .......................................................................30 428-1 ACTUAL VALUE < MIN, [NA] .......................................................................................................30 428-7 BROKEN WIRE, [NA] ...................................................................................................................30 429 INERT GAS DIFFERENTIAL FLOW (F164040-F164041) ...............................................................30 429-3 ACTUAL VALUE > MAX, [NA] ......................................................................................................30 430 INERT GAS PRESSURE (P164380) ...............................................................................................30 430-1 ACTUAL VALUE < MIN, [NA] .......................................................................................................30 432 VALVE INERT GAS (V164350).......................................................................................................29 432-1 FEEDBACK SIGNAL FAULT: OPENED, [NA] ..............................................................................29 432-2 FEEDBACK SIGNAL FAULT: CLOSED, [NA] ...............................................................................29 432-7 FEEDBACK SIGNAL FAULT: CONNECTED, [NA] .......................................................................29 433 VALVE INERT GAS (V164400).......................................................................................................29 433-1 FEEDBACK SIGNAL FAULT: OPENED, [NA] ..............................................................................29 433-2 FEEDBACK SIGNAL FAULT: CLOSED, [NA] ...............................................................................29 433-7 FEEDBACK SIGNAL FAULT: CONNECTED, [NA] .......................................................................29 438 PROCESS ......................................................................................................................................30 438-1 CONTAINER NOT INERTED, [2] .................................................................................................30 439 TEVA EXHAUST SUCTION ............................................................................................................30 439-1 FEEDBACK SINGAL FAULT: ON, [NA] ........................................................................................30

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6.3 Alarm shutdown levels

All alarms are defined into shutdown levels depending on the action they cause. For Container Mixer following shut down levels are available: Shutdown Level 1 level 1 shuts down the control enabled and activates automatically the shutdown level 2 Shutdown Level 2 level 2 shuts down the motors and drives

Alarm Text Shutdown level Page

164-6 VOLTAGE L+C NOT OK [1] 31

164-7 VOLTAGE L+E NOT OK [1] 31

165-1 EMERGENCY STOP ACTIVATED [1] 31

167-1 ACTUAL VALUE < MIN [1] 9

166-1 NO COMMUNICATION BETWEEN PLC AND PC [2] 31

399-2 CONTAINER SPEED NOT REACHED [2] 19

400-1 NOT SWITCHED ON [2] 12

401-1 PD623620 OIL FILTER DIRTY [2] 12

401-2 L623630 OIL LEVEL TOO LOW [2] 12

401-3 T623610 OIL TEMPERATURE TOO HIGH [2] 12

402-1 MALFUNCTION [2] 12

402-2 CONTROLLER AGGREGATE [2] 12

404-1 FEEDBACK SIGNAL FAULT: REACHED [2] 14

405-1 FEEDBACK SIGNAL FAULT: REACHED [2] 14

406-1 FEEDBACK SIGNAL FAULT: LOADED [2] 17

408-1 FEEDBACK SIGNAL FAULT: PIVOTED OUT [2] 16

408-2 FEEDBACK SIGNAL FAULT: PIVOTED IN [2] 16

409-1 FEEDBACK SIGNAL FAULT: REACHED [2] 14

412-1 FEEDBACK SIGNAL FAULT: CLOSED [2] 20

413-1 FEEDBACK SIGNAL FAULT: REACHED [2] 22

414-1 FEEDBACK SIGNAL FAULT: REACHED [2] 22

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Alarm Text Shutdown level Page

416-1 FEEDBACK SIGNAL FAULT: AT PLACE [2] 24

416-2 FEEDBACK SIGNAL FAULT: CLAMPED AND LOCKED [2] 24

417-1 FEEDBACK SIGNAL FAULT: CLAMPED [2] 24

417-2 FEEDBACK SIGNAL FAULT: RELEASED [2] 24

418-1 FEEDBACK SIGNAL FAULT: UNLOCKED OK [2] 24

418-2 FEEDBACK SIGNAL FAULT: RELEASED [2] 24

419-1 FEEDBACK SIGNAL FAULT: SIGNAL LOST [2] 16

424-1 FEEDBACK SIGNAL FAULT: LIMIT SWITCH G620580 [2] 28

424-2 FEEDBACK SIGNAL FAULT: LIMIT SWITCH G620581 [2] 28

438-1 CONTAINER NOT INERTED [2] 29

409-7 BROKEN WIRE [NA] 14

427-1 ACTUAL VALUE < MIN [NA] 28

427-2 ACTUAL VALUE < MINMIN [NA] 28

427-7 BROKEN WIRE [NA] 29

428-1 ACTUAL VALUE < MIN [NA] 29

428-7 BROKEN WIRE [NA] 29

429-3 ACTUAL VALUE > MAX [NA] 29

430-1 ACTUAL VALUE < MIN [NA] 29

432-1 FEEDBACK SIGNAL FAULT: OPENED [NA] 28

432-2 FEEDBACK SIGNAL FAULT: CLOSED [NA] 28

432-7 FEEDBACK SIGNAL FAULT: CONNECTED [NA] 28

433-1 FEEDBACK SIGNAL FAULT: OPENED [NA] 28

433-2 FEEDBACK SIGNAL FAULT: CLOSED [NA] 28

433-7 FEEDBACK SIGNAL FAULT: CONNECTED [NA] 28

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7 Parameters

The parameters of the units are divided into the following groups: Recipe Parameters

Parameters with direct influence like “inlet air temperature” or “air flow”.

Recipe parameters are loaded with the recipe therefore they are recipe-specific parameters. Within the recipe “BOP Parameters” and “Trippoints” are defined.

Machine Parameters

The machine parameters have indirect influence (except controller parameters) and are independent of the recipe and valid for all kind of processes.

Service Parameter Parameters related to general FB equipment or functions such as “opera-tion air pressure”.

Runtime Parameter The list "Runtime Parameter" shows the times, until which the control sys-tems is ready to wait for the limit switch to be reached.

Inertisation Parameter The Inertisation parameters are used for a correct inerting of the connected container.

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7.1 Recipe Parameters

Recipe parameters are parameters defined in the BOP and as trippoint.

7.1.1 BOP Parameters

Name Refer to Page blending speed ......................................................................................................................................73 blending time .........................................................................................................................................73 Container Inertisation .............................................................................................................................76 Inertisation required ...............................................................................................................................73

7.1.2 Trippoints

See chapter 4.15.2.

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7.2 Machine Parameters

7.2.1 Service Parameter

Service Parameter

Set

poin

t

act.

valu

e

Uni

t

Blending Speed 3 RPM x - incr. Blending Speed 15 RPM x - incr. Tilting to Interlock Speed x - incr. Lifting Speed Automatic 85mm x - incr. Lifting Speed Automatic 60mm x - incr. Lifting Speed Automatic slow 85mm x - incr. Lifting Speed Automatic slow 60mm x - incr. Lifting Speed Manual 85mm x - incr. Lifting Speed Manual 60mm x - incr. Lowering Speed Automatic 85mm x - incr. Lowering Speed Automatic 60mm x - incr. Lowering Speed Automatic fast 85mm x - incr. Lowering Speed Automatic fast 60mm x - incr. Lowering Speed Manual 85mm x - incr. Lowering Speed Manual 60mm x - incr. Tilting Speed Manual x - incr. Lifting Ramp 85mm x - incr./0.1s

Lowering Ramp 85mm x - incr./0.1s

Blending Acceleration x - incr./0.1s

Blending Deceleration x - incr./0.1s

Emergency Stop x - incr./0.1s

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Service Parameter

Set

poin

t

act.

valu

e

Uni

t

Lifting Pressure 85mm x - bar

Lifting Pressure 60mm x - bar

Lowering Pressure 85mm x - bar

Lowering Pressure 60mm x - bar

Blending Pressure x - bar

Deceleration Pressure x - bar/0.1s

Standby Pressure x - bar

Standby Flow x - incr.

Highest Position x - mm

Intermediate height 2 x - mm

Dispensing height 2 x - mm

Intermediate height 1 x - mm

Dispensing height 1 x - mm

Intermediate height M x - mm

Blending height x - mm

Intermediate height C x - mm

Docking height 1 x - mm

Docking height 0 x - mm

Actual Pressure Output - x bar

Actual Flow Output - x incr.

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7.2.2 Runtime Parameter

Runtime Parameter

Set

poin

t

Uni

t

Runtime Destination position x sec

Runtime Highest position x sec

Runtime Horizontal position x sec

Runtime Lowest position x sec

7.2.3 Inertisation Parameter

Inertisation Parameter

Min

.

Set

poin

t

Max

.

act.

valu

e

Uni

t

Inerting Inlet Pressure min Delay Time - x - x sec

Inerting Inlet Flow x - - x l/min

Inerting Outlet Flow x - - x l/min

Inerting Flow Difference - - x x l/min

Inerting Quantity Outlet - - - x l

Inerting quantity up to CS1000 - x - - l

Inerting quantity up to CS2500 - x - - l

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8 Interfaces section

8.1 Interface with users (HMI)

Operator Interface Terminal (OIT)

8.2 Interface with Teva

Signals are dry contacts from/to PLC. Type Description Usage

DOT BIN READY Pipeline feeding is connected and the bin are ready for dispensing.

Signal is “high”(TRUE) if: Container docked at dispensing station, dispensing phase active (in run) and phase parameter „Container Inertisation“ = FALSE + operator has confirmed that the container flap has been opened

DOT BIN N2 READY The pipeline feeding are connected and the container has been filled nitrogen.( Opening the lid will be allowed from Diosna Mixer).

Signal is “high”(TRUE) if: Container docked at dispensing, dispensing phase active (in run) and phase parameter „Container Inertisation“ = TRUE and inertisation finished or container already inerted + operator has confirmed that the CT flap has been opened

DOT BIN DISCONNECTED The pipeline feeding is not connected. (A local discharge possible).

Signal is “high”(TRUE) if: no bin on dispensing position

DIN TEVA EXHAUST GAS SUCTION ACTIVE

Signal is “high”(TRUE) if: Teva suction system is running and ok to exhaust the Nitrogen from bin inertisation.

DOT INERTISATION ACTIVE

Signal is “high”(TRUE) if: inertisation is active and not finished

Refer also to section 3.6.

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Appendix A: P&I Diagram