hzd1500 bin blender oq documents

HZD1500 Bin Blender

SAINTYCO INTERNATIONAL GROUP

Serial No: 170205

Year of Mfg: 2017.02

PART3: General Part _ Operation Qualification (GP- OQ)

Equipment: Bin Blender, Machine No.: HZD1500

HZD1500 BIN BLENDER

Operational Qualification (OQ) Protocol

SAINTY INTERNATIONAL GROUPPage 1

JN/JS/OQ-HZD1500

Operational Qualification Protocol for HZD1500 Bin Blender Version：V01

Writer‘s signature

Your signature indicates that the preparation of this file (Edit/Revision) complies with the

validation project of the equipment operational requirements of GMP and industrial production

process for bin blender. It also fully reflects the necessary tasks that shall be completed during

the validation procedure, and it can implement the Operational Validation of the HZD1500 Bin

Blender.

Name Title Signature Date Unit

Kevin Project manager April 1st,2017 SAINTYCO

Checker‘s signatureYour signature indicates you have carefully read this document and have confirmed its

exactness and this document fully reflects the validation tasks, and it can implement the

Operational Validation of the HZD1500 Bin Blender.


Wenju Pei Technician April 1st,2017 SAINTYCO

Approver’s signature

Your signature indicates that this document complies with the general plan of enterprise

validation, the technical production standards all the including files and information are

sufficient and can be directly applied. After the approval, any modification or correction to the

aim of this document or to the validation standard must be done in improving this document,

and before the execution of the modified/corrected document, it must be approved


Lei Zhang Technical Manager April 1st,2017 SAINTYCO


JN/JS/OQ-HZD1500


TABLE OF CONTENTS

1 PURPOSE.......................................................................................................................................................... 4

2 VALIDATION SCOPE...........................................................................................................................................4

3 PROTOCOL CHECKING..................................................................................................................................... 4

4 ORGANIZATION AND RESPONSIBILITIES.......................................................................................................... 4

5 SYSTEM DESCRIPTION.....................................................................................................................................5

5.1 NAMEPLATE................................................................................................................................................... 5

5.2 MAIN FUNCTIONS...........................................................................................................................................5

5.3 TECHNICAL USE.............................................................................................................................................5

5.6 REQUIREMENTS.............................................................................................................................................6

6 VALIDATION PROCEDURES AND RECORDS................................................................................................... 7

6.1 DOCUMENTS QUALIFICATION........................................................................................................................7

6.2 IQ QUALIFICATION.........................................................................................................................................7

6.3 MANUAL SETTING AND CALLING OF BLENDING TECHNICAL PROCEDURES (PARAMETERS).......................7

6.4 CLAMPING AND DISMANTLING OF THE BIN.................................................................................................. 8

6.5 AUTO LIFTING AND FALLING OF THE BIN.......................................................................................................9

6.6 OPERATIONALQUALIFICATION OF ROTARY BLENDING.................................................................................9

6.7 QUALIFICATION OF THE BIN POSITIONING..................................................................................................10

6.8 PRINTING OF TECHNICAL RECORDS...........................................................................................................10

6.9 SYSTEM PROTECTION................................................................................................................................. 11

6.10 QUALIFICATION OF THE FUNCTIONS OF THE TOUCH PANEL....................................................................11

6.11 TRAINING................................................................................................................................................... 12

6.12 ATTACHED PAGE OF THE RECORDS......................................................................................................... 12

7 DEVIATIONS...................................................................................................................................................12

7.1 DEVIATIONS LIST......................................................................................................................................... 12

7.2 DEVIATIONS REPORT...................................................................................................................................12

8 ATTACHMENTS LIST.......................................................................................................................................12

9 OQ EVALUATION OF OQ RESULTS AND SUGGESTIONS.......................................................................... 13

10 CHECKING AND APPROVAL..........................................................................................................................13

11 ALTERATION CONTROL..................................................................................................................................13

RECORD:

DOCUMENTS QUALIFICATION.................................................................................................................................... 14

IQ QUALIFICATION...................................................................................................................................................... 15

MANUAL SETTING AND CALLING OF BLENDING PROCESS PROCEDURES (PARAMETERS)

错误！未定义书签。

CLAMPING AND DISMANTLING OF THE BIN...............................................................................................................17


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QUALIFICATION OF AUTO LIFTING AND FALLING...................................................................................................... 18

OPERATIONALQUALIFICATION OF ROTARY BLENDING............................................................................................19

QUALIFICATION OF BIN POSITIONING........................................................................................................................20

PRINTING OF TECHNICAL RECORDS......................................................................................................................... 21

SYSTEM PROTECTION................................................................................................................................................ 22

QUALIFICATION OF FUNCTIONS OF THE TOUCH PANEL...........................................................................................23

TRAINING..................................................................................................................................................................... 24

ATTACHED PAGE OF THE RECORD............................................................................................................................ 25

DEVIATIONS LIST.........................................................................................................................................................25

DEVIATIONS REPORT.................................................................................................................................................. 25

ATTACHMENTS LIST.....................................................................................................................错误！未定义书签。

CHECKING AND APPROVAL OF THE EXECUTION......................................................................................................26

APPENDIX；

APPENDIXⅠ: OQ RESULTS EVALUATION AND SUGGESTION..............................................................................26


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1.PurposeThe purpose of this protocol is to provide guiding and technical standards to the operation

qualification of the HZD1500 Bin Blender.

This is to establish the validation protocol in order to obtain a document certifying that the

HZD1500 Bin Blender has been operated according to operational requirements of bin blender.

The acquisition of this document proves that the operation of the HZD1500 Bin Blender has

been implemented according to the approved protocol.

This protocol is the third part of the validation protocol of the HZD1500 Bin Blender:

Operational Qualification (OQ).

2.Validation Scope

Validation scope covers

functions,

operation procedures,

operation SOP,

training and other of the Bin Blender manufactured by SAINTYCO that is installed in

Room ______________, ID No.______________

Validation does not include separated validation of historic data.

3.Protocol Checking

At the following times, please check and ensure the suitability of this protocol:

When the principal part of the validation has been modified

When the validation scope has been modified

When the design has been modified

Prior to the execution of the OQ

During the review after the OQ has been completed

4.Organization and ResponsibilitiesDefine roles and responsibilities properly, according to their concrete division of labor.

All the personal participating to the execution of this protocol must provide their sample of

signature.


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5.System Description5.1 Nameplate NAME： Blender

MODEL：HZD1500

POWER SUPPLY： 440V/60Hz

SPEED： 3~15r/min

RATED CAPACITY：1500L

POWER： 10.5 kW

5.2 Main functions Manual clamping and dismantling of the bin

Auto lift and fall of the bin

Adjustable blending rotary speed between 3～15rpm

Blending finished, bin positions automatically

Blending finished, print technical record

Manual setting and calling of blending technical procedure (Parameters)

Failures alarms during automatic operation process

5.3 Technical useThe equipment is mainly used for blending dried granules or powder.

5.4 Main technical parameters see Table B3-01

Table B3-01 Main technical parametersModel HZD1500

Adaptive bin type LDZ1500 LDZ1000-1500 LDZ500-1500

Capacity L 1500 1000 500

Working load kg 750

Working speed r/min 3～15

Mixing time min 1～60

Mixing motor power kW 7.5

Lifting motor power kW 3


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5.5 ManufacturerSanity International Group

402#， Tower-1, Pearl Mansion, Block-3, Rui’an city, Zhejiang Province, China

Website：www.saintyco.com

Email：[email protected]

Tel：（86）0577-66612826

5.6 Requirements5.6.1 Every validation results shall be truly and integrally filled in the Operational Qualification

Report OQR, this manual has provided a template of OQR.

5.6.2 Inspector and checker will decide whether the validation results are up to scratch, OQR

shall clearly indicate whether the validation has been passed. Inspector and checker shall sign

and record the date on the related chapters and sections; putting a tick as signature is

forbidden. On places that are not suitable to the system, please use N/A for indicating and

write the reason the suitable place.

5.6.3 The inspection file shall be kept as part of the inspection records, all the main accidents

should be recorded on the inspection file, such as system damages or failures causing the stop

of the inspection.

5.6.4 A group (or a day) of validation accomplished, validation group shall summarize briefly

the formed results or datum and shall conclude it (including inspection datum which are not up

to standard).

5.6.5 All deviations appeared during validation shall be recorded in the Deviation Report (DR).

5.6.6 After analyzing inconsistent items and deviations, they shall be validated again; this

validation can used actual protocol or change for another mode of qualification.

5.6.7 Every validation finished, results or records shall be analyzed again to form the

Operational Qualification Report. The Report should explicitly mention whether this validation

has been passed or not.

5.6.8 All the records, IQR, DR and the lastly formed Operational Qualification Report shall be

arranged, filled in a document for archiving and should be kept and saved as part of the

equipment dossier


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6. Validation Procedures and Records6.1 Documents Qualification

Purpose:

Qualify the documents pursuant to operational qualification of the blender system are fully

valid.

Procedure

Check carefully the following documents and qualify their integrality and

validity:

HZD1500 Bin Blender Product Manual

Electric configuration list

Qualification standard

The above applicable documents are the newest editions of the related system

Record

Record the validation result in OQR01;

Record deviation appeared during the qualification process in the deviation report.

6.2 IQ QualificationPurpose

Qualify the IQ has been successfully executed and approved.

Procedure

Qualify the IQ document exists and has been executed and approved, moreover

errors have been clearly indicated. All the IQ errors shall have been evaluated and

ensured that these errors won’t influence the results of OQ.


IQ has been executed and approved; moreover all the IQ errors that may influence

the OQ results have been treated or clearly indicated.

Record



6.3 Manual setting and calling of blending technical procedures (Parameters)Purpose


JN/JS/OQ-HZD1500


Qualify the technical procedures management (Setting and calling) of the blender

system complies with requirements of technical management for blending operation.

Procedure

Refer to the product manual or draft SOP operation and check the following items of

OQ:

A） Setting contents of technical procedures:

Technical procedures/Medicine name

Blending time

Blending speed

Storage code

B） Number of pre-set technical procedure groups

C） Qualification of calling of technical procedure

Acceptable standard

The technical procedures management (Setting and calling) of the blender system

complies with requirements of technical management for blending operation.

Record



6.4 Clamping and dismantling of the BinPurpose

Qualify the clamping and dismantling of the bin complies with requirements for

operation and running.

Procedure

According to “Product manual” or “Operation SOP”, qualify clamping and dismantling

tasks of the bin:

Connection of the bin to the main machine

Operation process of the bin

Qualification of bin in position


The clamping and dismantling of the bin complies with requirements for operation

and running.


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Record



6.5 Auto lifting and falling of the binPurpose

Qualify the process and the stability of the auto lifting and falling of the bin comply

with URS and DQ requirements.

Procedure


OQ:

Lifting reducer

Lifting screw-nut pairs

Acceptable standard

The process and the stability of the auto lifting and falling of the bin comply with URS

and DQ requirements.

Record



6.6 Operational Qualification of rotary blendingPurpose

Qualify the operational reliability and stability of blender comply with design

requirements.

Procedure


OQ:

Blending reducer

Blending time

Blending speed

Stability of the blending process

Acceptable standard

The operational reliability and stability of blender comply with design requirements.


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Record



6.7 Qualification of the bin positioningPurpose

Qualify, on blending finishing, the correct positioning of the bin complies with design

requirements.

Procedure

Refer to the product manual or draft SOP operation, execute:

Manual positioning

Auto positioning

Positioning after a manual stop of the process

Acceptable standard

The reproducibility of the bin positioning is fine and in every condition the bin can be

positioned in the same state.

Record



6.8 Printing of technical recordsPurpose

Qualify the printing of technical records complies with requirements for management

of batch number and quality traceability.

Procedure

Refer to the product manual or draft SOP operation, qualify

Instant printing after blending is finished

Reading and printing of historic records

Acceptable standard

The printing of technical records complies with requirements for management of

batch number and quality traceability, and is consistent with product manual or SOP

descriptions.


JN/JS/OQ-HZD1500


Record



6.9 System protectionPurpose

Qualify the system protection of the blender complies with safety

requirements.

Procedure

Qualify the following items:

Emergency stop

Operation interruption

Alarms

Mechanical safety

Acceptable standard

The system protection of the blender complies with safety requirements.

Record



6.10 Qualification of the functions of the touch panelPurpose

Qualify the functions of the touch panel are consistent with pre-qualified

contents.

ProcedureQualify the following items:

Touch panel

Buttons

Acceptable standardThe functions of the touch panel are consistent with pre-qualified contents.

RecordRecord the validation result in OQR10;



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6.11 TrainingPurpose

Qualify the relative personnel has the suitable capacity for the system using, servicing

and daily management.

Procedure

Check the training plan and implementation record of the personnel for the system

using, servicing and daily management, qualify they have received effective training.

Acceptable standard

The personnel for the system using, servicing and daily management has received

effective training, and has the suitable capacity.

Record



6.12 Attached page of the recordsIf the main record pages are not enough, the record like OQR12 can be used, then give a

clear indication of the title of the number and Qualification record reference.

Deviations

7.1 Deviations listCollect all the deviations appeared during the OQ activities to form the deviations list and

indicate date of solution.

7.2 Deviations reportRecord all the deviations and their management occurred during the protocol execution

process and analyze their effects on Validation conclusion.

Record the records contents, cause analysis, improved situations and effects on

Validation conclusion in the deviations report.

8. Attachments listCollect all related documents, records, videos. CDs, use them as attachments for the

validation report. Compile the attachment list, specify the pages and use conditions.


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9. OQ Evaluation of OQ results and suggestionsCollect all records and reports of chapters 6, 7 and 8. Validation group uses procedures

below to evaluate the results and to put forward some suggestions:

Check the review of the qualification process

Check and analyze the records

Check and analyze the deviations report

Draft out the conclusion

Discuss and approve the report

10. Checking and ApprovalReport is checked and approved by authorized person.

Validation Report and its attachments shall be arranged, filled in a document for archiving

and should be kept and saved as part of the equipment dossier.

Appendix I have provided an example of Operational Validation Report.

11. Alteration controlAny change of the equipment must be checked and approved by both parts, and then

changed files should be archived.


JN/JS/OQ-HZD1500


OQR of HZD1500 Bin Blender Record No. OQR：01 Manufacturer SAINTYCO

Qualify/Date Check/Date

name：Documents QualificationDocument name

（PASS）（FAIL）（N/A）

Product Manual

Electric configuration list

Other：

Any deviation? □（YES） □（NO）

Deviation recorded in DR, DR No. is：DR

Recorder Checker Checker CheckerSignature

Date


JN/JS/OQ-HZD1500


OQR of HZD1500 Bin Blender Record No. OQR02 Manufacturer SAINTYCO


Name：IQ Qualification

NO. Description Expected result Measured result Conclusion

1 Qualify the IQ document exists andhas been executed and approved,moreover errors have been clearlyindicated. All the IQ errors shallhave been evaluated and ensuredthat these errors won’t influence theresults of OQ.

□ PASS

□ FAIL

Other：




Date


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Manual setting and calling of blending process procedures (Parameters)

Item Description Conclusion

Contents of processprocedure setting

Process procedure/Medicine name: 10 numbers orletters code

□Yes □No

Blending time: can be set at will 1~60 min. □Yes □No

Blending rotation speed: 3~15rpm □Yes □No

Storage code：0~49 □Yes □No

Number of pre-set processprocedure groups

50 Groups □Yes □No

Calling of processprocedure

Input process procedure code: confirm a groupbetween 0~49

□Yes □No

Confirmation of the technical parameter in the menu □Yes □No

Other：




Date


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Name： Clamping and dismantling of the bin


Checking of the bin Bin is covered with a lid and clamped with a hook,butterfly valve is closed

□Yes □No

Connection of the bin tothe main machine

The bin is pushed into rotary frame, four legs of the binare aligned with the clamping devices on chassis of

rotary frame

□Yes □No

Clamp in place process2/3 area of the stacking plate at the bottom of bin is

reliably pressed when clamped□Yes □No

Clamp sensor receives signal that bin is clamped inplace and will stop

□Yes □No

Lowered in placequalification

When lowered in place, motor will auto stop □Yes □No

Other：




Date


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Name：Qualification of auto lifting and falling


Lifting motor Stable operation of motor, operation without oil leakage □Yes □No

Screw-nut pairs Continuous Bin lifting and falling without any block □Yes □No

Operation noise on fully loaded □Yes □No

standard value measured value

≤75dB（A）

Positioningconfirmation

Sensors of the clamping device sends stop signal when binclamped in position

□Yes □No

Bin fallen to ground position, motor stops automatically □Yes □No

Other：




Date


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Name: Operational Qualification of rotary blending


Blending reducer

Continuous stabile of operation current, the current is not more than110％ of the rated value of the motor ( )A

□Yes □No

Operation of reducer without oil leakage or abnormal noise □Yes □NoAfter 20min continuous operation, temperature rise at the middle ofthe motor housing is not more than 35°

□Yes □No

Blending time

Mixing time:1~60min, time deviation is within the 3% of set value; forexample: on empty load condition: set one mixing speed, and useseveral different mixing time , measured with stopwatch

□Yes □No

set value measured valve

10min30min60min

Stability ofblending process

On blending operation, left/right frames haven’t obvious vibration □Yes □NoThere’s no displacement of the bin the rotary frame □Yes □No

Blending speed

Rotation speed is 3~15r/min, when without load, bin rotates10 circle with rotation speed 3 r/min, and work out its rotation speed

□Yes □No

setting value：3 r/min actual value


□Yes □No



□Yes □No


Other：




Date


JN/JS/OQ-HZD1500




Name：Qualification of bin positioning


Auto positioning

On auto operation ending, bin auto positions tooriginal blending position

□Yes □No

After positioning, check visually the rotary frame isvertical to the ground定位转速 Positioning rotation speed: 3rpm

Positioning after a manualprocess stop

After manual stop of auto procedure, manualpositioning can be used

□Yes □No

After positioning, check visually the rotary frame isvertical to the groundPositioning rotation speed: 3rpm

Manual positioning

On failure of auto positioning, use manualpositioning

□Yes □No

After positioning, check visually the rotary frame isvertical to the groundPositioning rotation speed: 3rpm

Other：




Date


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Name: Printing of technical recordsItem Description Conclusion

Instant printing onblending finishing

Date, format like ××××Y××M××D □Yes □No

Operator code, 4 letters or numbers □Yes □NoMedicine name, 10 letters or numbers □Yes □NoMedicine batch number, 10 letters or numbers □Yes □NoBlending time, ××min. □Yes □No

Blending speed, ××rpm□Yes □No

Reading of historicrecord

Can auto record the latest 20 groups of auto operation □Yes □No

On records searching menu, records can searched andprinted

□Yes □No

Printing of historicrecord

Instant printing on printing content order □Yes □NoDate is the blending date □Yes □No

Other：




Date


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Name： System protection


Emergency stop

Emergency stops are set on main operation panel and left frame □Yes □No

Press the emergency stop switch to stop the whole operation □Yes □NoOn pressing the emergency stop switch, alarm device executesacoustic and optical alarm

□Yes □No

On pressing the emergency stop switch, touch panel displays“Emergency Stop” menu

□Yes □No

Operationinterruption

Human interruption (like emergency stop, system suspend),touch panel displays relative menu

□Yes □No

Start after power-cut, touch panel displays “System power off”menu

□Yes □No

Resume interruption, system indicates with acoustic and opticalarm

□Yes □No

AlarmsOn pressing the emergency stop, system alarms □Yes □No

Mechanical protection guardrail is carried out by thephotoelectric switch

□Yes □No

Other：



Recorder Checker Checker Checker

Signature

Date


JN/JS/OQ-HZD1500




Name： Qualification of functions of the touch panel


Touch panel Start system, background light lights; stop system,background light extinguishes

□Yes □No

Button

Operationbuttons

Choosing a button of the panel, relative operation menushall appear, such as operation option, auto, manual andso on; it shall be consistent with expected design.

□Yes □No

Printingbutton

Printing button of touch panel, the printer prints all thestored datum(operator No., print date, batch No….relatedprint see TR08 )

□Yes □No

Other：




Signature

Date


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Name: Training

Training project name Training project No.

Training record No.

Training contents

Equipment system and basic machine configuration

knowledge training

System work principle training

SOP training

System daily management and maintenance knowledge

training

Other knowledgeEvaluation of training effects Operators, equipment administrant and maintenance

personnel control the knowledge and skill of their ownjob requirements.

Conclusion

Other：




Signature

Date


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Name：Attached page of the record

Record No. OQR Record name PagesTotal pages:Page No.



Name：Deviations listDeviation No. Qualification

record No.Description Date of solution



Name：Deviations report

Deviation No. Record No.

Déviations description：

Signature Date

Reason analysis：

Signature Date

Improvement measure： Improvement result：

Signature/Date Signature/Date

Improvement results have positive effects on

operation validationYes No


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Name：Checking and Approval of the execution

Check the OQ results and original data, then form the ultimate conclusion of the OQ:

PASS □ FAIL □

If there’s still unsolved deviations, please fill down the following content:

Qualify if these unsolved deviations may influence the ultimate conclusion of the OQ.

YES □ NO □

Note：

Executed by

Signature Signature

Checked by

Signature Signature

Checked by

Signature Signature

AppendixⅠ: OQ results evaluation and suggestion


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OQ Result Evaluation and Suggestion

1. Purpose

This is to set the evaluation of the HZD1500 Bin Blender, and to conclude if the activities of OQ

meet equipment requirements, and if the Equipment qualification can be concluded and

suggested.

2. Scope Operational Qualification of the HZD1500 Bin Blender manufactured by SAINTYCO

installed in Room , ID No.

The contents of this validation document refer to the equipment, testing steps,

specifications, documentation. This information will be used to ensure that the

blender has been installed, operated and run according to the user’s design

specifications and company’s requirements.

This document is compiled by SAINTYCO, and then the related approval signature,

supporting documents and other documentation will be included. Any supporting

datum and documentation shall be attached to the inspection report.

3. SummaryThe validation of this equipment activities have been done according to the procedure

requirements of the Company (Management regulations of equipment validation), the

validation group proceeds according to the validation protocol of the HZD1500 Bin Blender.

The protocol should have the entire OQ validated and results of the checking listed. By the

validation process, the checking and auditing of the reports and deviations reports, qualify that

the protocol, during the implementation process, has no modification, is real and complete and

accords with requirements of the protocol.

The validation group, after has discussed, approves the Operational Qualification (OQ) of the

Bin Blender.


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4. Qualification record

No. Item Evaluation and analysis

1 OQR1： PASS□ FAIL□ N/A□

2OQR2： PASS□ FAIL□ N/A□















Conclusion

Activities of the Operational Qualification accord with the requirements of the

protocol, operation of the Bin Blender accords with standards of the equipment and

design, industrial manufacturing and GMP requirements. And can go to the next step

activities and equipment validation or equipment trial operation.


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5. Results evaluation and suggestions

The group, after has checked the content report of the equipment validation and has discussed,

approves that the Operational Qualification (OQ) of the equipment accords with the

requirements of the protocol, thus Performance Qualification (PQ) of the equipment can be

performed.

By the validation process, the checking and auditing of the reports and deviations reports,

qualify that contents related to the OQ of the protocol, during the implementation process,

have not been modified, records are real and complete. The members of the validation group,

after have discussed, declares unanimously that activities of the Operational Qualification

accord with the requirements of the protocol, operation of the Bin Blender accords with

standards of the equipment and design, blender system accords with industrial manufacturing

and GMP requirements. And can go to the next step activities and equipment validation or

equipment trial operation.

6. List of signatures of validation group members (Brief)

7. Signatures

Executed by _

SignatureDate

(dd/mm/yyyy)

Checked by ____________________________ __________________

SignatureDate

(dd/mm/yyyy)

Checked by ____________________________ __________________

SignatureDate

(dd/mm/yyyy)


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AC Alternating current

A Ampere

V Volt

Hz Hertz

PLC Programmable Logic Controller

ºC Degrees Celsius

DQ Design Qualification

IQ Installation Qualification

OQ Operational Qualification

PQ Performance Qualification

FAT Factory Acceptance Test

SAT Site Acceptance Test

DQR Design Qualification Report

IQR Installation Qualification Record

OQR Operational Qualification Record

PQR Performance Qualification Record

DR Deviation Report

N/A Not Applicable

SOP Standard Operating Procedure

RSD Relative Standard Deviation

hzd1500 bin blender oq documents

Health & Medicine