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October/2015 Edition

Data Sheetfor J-200 micronization equipments

Many decades of experience in the field of plant construction added to our know-how in the field of thepowder micronization and related apparatus make us the right partner in the supply of integrated and upto date solutions. Individual solutions for plants are our daily job.

We engineer systems in our workshop and provide consulting on location. High technical knowledgeand competence of our team – comprising experienced engineers, technicians, fitters, andcommissioning personnel form the basis of successful cooperation.

The original principles of jet milling are simple. The powder particles are fed into the milling chambertangentially through a Venturi system by pressurized process gas, generally air or nitrogen. Theparticles are accelerated in a spiral movement inside the milling chamber by a number of nozzles placedaround the periphery of the milling chamber. The micronizing effect takes place by the collision betweenthe slower incoming particles and those already accelerated in the spiral stream. Centrifugal forcesretain the larger particles at the periphery of the milling chamber, while the smaller particles exit withexhaust gas from the centre of the chamber by means of a static classifier and are recovered in acollecting container just beneath the jet mill.The PSD (particle size distribution) is controlled by adjusting two parameters: Pressure and Feed rate.

Our engineering team has prepared in the following pages an overview of the most importantcharacteristics of our J-200 micronization line. For presentation of the newest technology, the completerange of our products and engineering performances and last but not least to go in more detaileddiscussion concerning the project and in particular your requirements, we would be pleased to get thepossibility to introduce ourselves in our workshop.

Contents

1.0 Technical Specification

2.0 Documentation

3.0 Options

4.0 Start-up and Commissioning

5.0 Guarantee

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1.0 Technical Specification

[General Provisions]

Working environmentOur micronization unit can be installed in ambient conditions without explosion risks (non classifiedzones). The unit is also built to be easily assembled/disassembled and easily cleaned. Furthermore itoffers a very high degree of resistance from powder penetration.

Principles of designThe unit has been designed to mainly work with several types of food and pharmaceutical products. Theplant is not foreseen to work with flammable products or products that can generate explosiveatmospheres. It is conceived in order to avoid product contamination, considering both normal use andthe malfunction case. The unit can be cleaned with most common detergents, solvents and alcohols.

Applied standardsThe unit has been designed and constructed in compliance with the following standards:

Machinery Directive (2006/42/EC) and any relevant provisions. Electromagnetic Compatibility (2004/108/EC) and Low Voltage Directives (2006/95/EC) and

subsequent amendments. cGMP guidelines.

ErgonomicsThe unit is mounted on a mobile supporting table in which is predisposed an easily readable controlsystem, the positioning of the components is conceived in order to easily allow the cleaning,assembly/disassembly and charging/discharging operations.

[Equipment Specification]

Process gas manifoldThe process gas manifold comprises:

supporting structure with process gas inlet one emergency ball valve pressure switch for the main pressure line one thermometer (-30C +50°C) two pressure gauges (1-16 bar) two ball valves for process gas connection to the jet mill with flexible and rigid pipes and tri-clamp connections

Supporting structureThe structure is conceived in order to support all the jet mill linked components (process gas manifold,feeder, control panel and instruments). It is conceived to allow the necessary adjustment to connect thedifferent components of the micronization line. The instrumentation is lodged in a cockpit fully integratedinto our Lab Ship docking table on revolving wheels.

Feeder model K-Tron K-MV-KT20Feeder model K-Tron K-MV-KT20 volumetric type comprising:

horizontal double screw for product transportation feed rate regulation by Drive or Inverter based control system product hopper with capacity 10 litres and upper safety grill

The feeding unit is modified to fit our fluid jet mill unit with: a stainless steel feeder support table it is further machined to meet our standard finishing for contact parts

In addition another power panel is included to allow the simultaneous switch off of the J-200 and thefeeding unit to conform EC norms.

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Electrical power and protection:feeder 0.55 kw –230V 50Hz –IP55 (motor)feeder control panel 230V 50Hz –IP55

Tee connectionTee-connection with lateral tri-clamp open entry of the twin-screws, lower tri-clamp connection andupper lid with inspection glass.

Jet MillOur J-200 fluid jet mill is completely openable and it is comprised of:

3 Venturi system (S, M, L) to feed product into milling chamber upper plate lower plate central ring interchangeable nozzles/ring to inject the process gas static classifier for micronized product classification

Upper plate, lower plate and central ring are held together by a unique special half ferrule handleclosure. The central ring is provided with a tri-clamp to connect the ring process gas pipe of themanifold, the mill is also complete with a Venturi-hopper (connected to the Tee-connection) and anadjustable main injector system connected to the Venturi process gas pipe of the manifold.

All these components are easily assembled/disassembled by means of: one nozzles disassembling tool one nozzles assembling tool one torque wrench set for the jet mill closing handles fast opening tri-clamps

Flexible Product LineProduct line in polyurethane (PUR), with special ferrules and tri-clamp connections at both ends. Itconveys the micronized product from the fluid jet mill to the cyclone filter:

standard length = 3 m internal surface = smooth external surface = wavy

Cyclone FilterCyclone filter, diameter 750/600. This is a closed model supported by lateral legs with adjustable feetand the connection points for the grounding point. The cyclone consists of:

one cylindrical gas/solid separation chamber equipped with filtering sleeves with surface of 8 m²to collect the solids

one tronco-conic tangential entry to achieve the separation of the dust from the gas. Thetangential entry of the gas favours the centrifugation and the precipitation of the micronizedproduct

The cyclone filter is built to allow comfortable access to the filter sleeves in order to clean or to changethem through an inspection door.The filter sleeves are made from anti-static polyester cloth and they are shaken by a pneumatic-mechanical system.

The cyclone filter allows separation of product from the filtered process gas; the latter is evacuatedthrough a 4”exhaust pipeline located on the upper part of the cyclone and connected with the finalfiltering unit (see options) or to your aspiration and filtering system. The product discharge takes placethrough one manually operated discharging butterfly valve diam.250 mm.The cyclone filter is also equipped with:

safety switches mounted on the access door pneumatic panel with solenoid valve to control the pneumatic cylinder turning and braking wheels or adjustable feet.

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Removable lower conical part of the cyclone filterThe lower part of the cyclone filter has the only surface in contact with the product. The upper part isdownstream of the filtration. The conical part, together with the filtering sleeves is built to be easilyremoved from the main body of the cyclone filter and brought to the washing room.

Central control panelMain panel comprising:

general ON/OFF switch emergency push-button power supply push-button alarm reset push-button main process gas valve RESET push-button feeder ON/OFF push-button function digital display alarm indicator for lack of air pressure Δp meter for pressure control in the cyclone filter alarm and pre-alarm indicators for clogged filter sleeves one START-STOP selector switch for shaking the filter sleeves one up/down selector for the filter sleeves position (for maintenance operations)

If functionally required the above mentioned components can be substituted by PLC/HMI based controlsystem or they can be distributed in more panels with the same finish, material and protection.

[Utilities]

Process gas

Output at 7 bar 1.7 m3/min (60.0 ft3/min) 102.0 m3/h (3600.0 ft3/hour)Output at 12 bar 2.74 m3/min (96.8 ft3/min) 164.4 m3/h (5808.0 ft3/hour)

Design pressureThe fluid jet mill is designed for working pressure of 12 bar (tested at 18 bar)

Gas design temperatureThe mill is conceived to work with a gas between 0°C and 50°C

Environment design temperatureThe mill is conceived to work in an environment between 0°C and 40°C

Electrical power and protection:Electrical panel 230V 50Hz IP55Feeder 230V 50Hz 0.45kW IP55 (motor)

[Manufacturing Materials and Finishes]

All metallic parts coming into contact with the product are made in Aisi 316L (EN 1.4404) stainless steel,all other metallic parts are made in Aisi 304L (EN 1.4307) stainless steel. The anti-static filtering sleeveis made in Polyester with stainless steel wire.

Gaskets in contact with the product are manufactured with silicone, ptfe or kaflon, other gaskets aremanufactured in epdm or ptfe.

All surfaces in contact with the product are mirror polished (Ra ≤ 0.25 μm), surfaces not in contact withthe product are satin or mirror polished 220 grit (Ra ≤ 0.8 μm).

Feeder: motor and gear-reducer are in aluminium or painted steel (non contact parts).

Characteristics of materials and finishes not corresponding to the above mentioned description areindicated in the technical specification.

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2.0 Documentation

Project Book is composed by:

EC declaration of conformity Use and maintenance manual with product guarantee, instrument calibration certificates,

instrument data sheets, and general assembling drawings Spare parts manual Linearity test feeder certificate Manufacturing book, complete of

o hydraulic test certificateo dye penetrant certificateo roughness test certificateo dimensional inspection certificateo material certificate 3.1.B or 3.1 as per Uni En 10204 for metallic contact parts

FAT report

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3.0 Options

[Milling chamber]

Adjustable nozzle anglesThis option makes possible to use different nozzle angles in order to achieve the required finenessvalue, whereby the complete nozzle ring must be exchanged in this case.

Elliptical milling chamberThis option makes possible to keep the fluid jet flow totally contained into an elliptic field of forces, thismakes possible to achieve extremely narrow particle size distributions.

Static classifierThree different static classifiers are available:

Multipurpose Reverse vortex effect Unclogging effect

depending by product nature, the specific classifier enhances product flow and productivity.

[Manifold]

Diaphragm valves instead of two ball valvesIn the sterilize in place execution, to avoid any contamination risks of the inlet process gas.

Point of use filterTo allow filtration of the process gas which will be injected into the Venturi inlet and into the central ring.This is recommended when the customer’s pipeline is not provided with any cartridge filter. In stainlesssteel with tri-clamp connections and sterilizable cartridge (the cartridge is not sterilizable in place).

Process gas conditioning systemIt is a patented system designed for introducing metered moisture or organic solvent into the processgas stream to suit products requirements, particularly indicated if the source is dry nitrogen. The systemworks at fixed set-points of temperature and pressure at the thermodynamic balance value of theconditioning solvent. More than the 90% of the process gas can be conditioned by this system.This technique addresses many problems for example:

It reduces production downtime with very sticky products It permits to change the product structure opening the possibility to extend the product patent It removes the necessity to put moisture back into the product after the micronization process It can be extended to many areas…

[Feeders]

Hopper lid for 50 litres hopper for K-TRON K-MV-KT20With handle and without clamp and gasket.

Hopper lid for 50 litres hopper (closed system) for K-TRON K-MV-KT20With clamp, gasket and polyester compensation filter (to utilize with the balance line and productcontainer).

80 litres Hopper instead of 50 litres hopper for K-TRON K-MV-KT20For the standard feeder with upper safety grill.The 80 litres hopper and the 50 litres hopper have the same upper diameter, therefore the 80 litreshopper doesn’t need a specific lid.

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Feeder model K-Tron K-PH-MV-KT20Special pharmaceutical execution feeder similar to model K-Tron K-MV-KT20 with the following furthercharacteristics:

the motor and the step-down gear box are completely closed in a stainless steel canister especially welding finished and polished small hopper with screw housing obtained by single solid piece

Hopper lid for 50 litres hopper for K-TRON K-PH-MV-KT20With handle and without clamp and gasket.

Hopper lid for 50 litres hopper (closed system) for K-TRON K-PH-MV-KT20With clamp, gasket and polyester compensation filter (to utilize with the balance line and productcontainer).

80 litres Hopper instead of 50 litres hopper for K-TRON K-PH-MV-KT20For the standard feeder with upper safety grill.The 80 litres hopper and the 50 litres hopper have the same upper diameter, therefore the 80 litreshopper doesn’t need a specific lid.

Feeder model DS50-PH horizontal double screw for product transportation feed rate regulation by control system product hopper with capacity 10 litres and upper safety grill the motor and the step-down gear box are completely closed in a stainless steel canister especially welding finished and polished small hopper with screw housing obtained by single solid piece a Tee-connection in stainless steel having lateral open entry of the twin-screw, upper inspection

glass and lower tri-clamp connection to the Venturi-Hopper a stainless steel feeder support table

Electrical power and protection:feeder 0.46 kw –AC 220V 50-60Hz –IP65 (motor)feeder control panel IP20

Hopper lid for 50 litres hopper for DS50-PHWith handle and without clamp and gasket.

Hopper lid for 50 litres hopper (closed system) for DS50-PHWith clamp, gasket and polyester compensation filter (to utilize with the balance line and productcontainer).

80 litres Hopper instead of 50 litres hopper for DS50-PHFor the standard feeder with upper safety grill.The 80 litres hopper and the 50 litres hopper have the same upper diameter, therefore the 80 litreshopper doesn’t need a specific lid.

Feeder model Peristaltic with screwFeeder model peristaltic of volumetric type comprising:

horizontal single screw for product transportation peristaltic funnel feed rate regulation by Drive or Inverter control system product hopper with capacity 10 litres and upper safety grill

The feeding unit is modified to fit our fluid jet mill unit with: a Tee-connection in stainless steel having lateral open entry of the twin-screw, upper inspection

glass and lower tri-clamp connection to the Venturi-Hopper a stainless steel feeder support table it is further machined to meet our standard finishing for contact parts

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Electrical power and protection:feeder 0.55 kw –230V 50Hz –IP55 (motor)feeder control panel 230V 50Hz –IP55

Hopper lid for 50 litres hopper for Peristaltic FeederWith handle and without clamp and gasket.

Hopper lid for 50 litres hopper (closed system) for Peristaltic Feederwith clamp, gasket and polyester compensation filter (to utilize with the balance line and productcontainer).

[Product line]

Product line in stainless steel instead of PUR, single pipe max length 500 mm (in order to easily allowcleaning), total max length 3000 mm, with tri-clamp connections.

[Balance line]

This option enables the hermetical sealing of the whole unit, in this way the product will be in contactonly with process gas.

Balance line in PUR (flexible, economic and easy to assemble)With special ferrules and tri-clamp connections at both ends.Tee-connection with lateral sealed entry of the twin-screws, lower tri-clamp connection and upper tri-clamp connection to a 360° inspection glass.The balance line connects the upper part of the 360° inspection glass to the upper part of the cyclonefilter.

Balance line in stainless steelSingle pipe standard length 500 mm, total max length 3000 mm, with tri-clamp connections.Tee connection with lateral sealed entry of the twin-screws, lower tri-clamp connection and upper tri-clamp connection to a 360° inspection glass to the upper part of the cyclone filter.

[Cyclone filter]

Filtering mediaThree different filtering media are available:

P65 P100 P200

depending by product nature, the specific filtering media enhances product yield and productivity.

RIP (rinsing in place) pre-arrangementComprising ferrules and caps to receive 3 spray balls in the upper part and 3 sprinklers in the lower partof the cyclone filter. Drainage ferrule and cap in the upper part of the cyclone filter.

WIP (washing in place) pre-arrangementComprising ferrules and caps to receive 3 spray balls in the upper part and 3 sprinklers in the lower partof the cyclone filter. Drainage ferrule and cap in the upper part of the cyclone filter.Reinforcement of the inspection door and closing handles to resist the pressure generated by thecomplete flooding of the cyclone filter

RIP/WIP systemComprising 3 spray balls and peripheral piping with tri-clamp connections in the upper part of thecyclone filter and 3 sprinklers and peripheral piping with tri-clamp connections in the lower part of thecyclone filter. Supplementary cap at the cyclone filter exit for the drainage of the lower part and drainageferrules for the upper part.

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Rotary Valve DN150 instead of the discharging butterfly valveOur rotary valves are especially developed and optimised for micronized powders. Rotor with 6 blades.Easy assembly/disassembly through tri-clamps, easy cleaning.Motor power 0.37kW / 4 phasesPower supply 400V / 3 phases / 50HzMotor protection IP55Rotation speed fixed: range 3.5-20 rpm (eventually to be defined after micronization trials)Central panel modifications comprising:

- ON/OFF push-button for rotary valve- Alarm indicator for rotary valve

Process Analytical Technology (PAT)It is a system for designing, analyzing and controlling micronization process through timelymeasurements of critical quality and performance attributes of raw and in-process materials andprocesses with the goal of ensuring final product quality. Our cyclone filter can be supplied with twodifferent solutions aimed to:

- At-Line Measurement with a Powder Sampling DeviceManual system for sampling up to 20 cm³ of powder in-line, without stopping theprocess, placed at the cyclone filter exit, tri-clamp connections.

- In-Line Measurement with a Powder Laser AnalyzerAutomatic system based on laser diffraction for the Intelligent Mill Control using on-lineparticle sizing on powder processing.

Conical part with Pneumatic LegsThe lower conical part of the cyclone filter is equipped with three removable legs with turning andbraking wheels, these wheels are equipped with pneumatic cylinders which allow to do the maintenanceoperations very easily with only one operator instead of three.

[Final filtering]

Final filtering unit (2 filters)Filtering unit comprising:

one inlet conveyor two canisters for pre-filter G4 and absolute filter (HEPA) H13 (MPPS) one centrifugal fan with reversible blades. Motor power 1.5kW. power supply 400V / 50Hz (anti-

spark) two differential manometers for measuring filter clogging

Material: carbon steelFinishes: paintedGaskets: neopreneDocumentation: certificate of conformity for the absolute filter as per EN 1822 and for the pre-filter asper EN 779.

Final filtering unit (3 filters)Filtering unit comprising:

one inlet conveyor three canisters for pre-filter G4, semi-absolute filter F6 and absolute filter (HEPA) H13 (MPPS) one centrifugal fan with reversible blades. Motor power 1.5kW. power supply 400V / 50Hz (anti-

spark) three differential manometers for measuring filter clogging

Material: carbon steelFinishes: paintedGaskets: neopreneDocumentation: certificate of conformity for the absolute filter as per EN 1822 and for the semi-absoluteand pre-filter as per EN 779.

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Pressure control systemIf the Filtering Unit is in the scope of the supply, the control of the internal pressure of the cyclone filtertakes place by means of a centrifugal fan controlled by an inverter. With the centrifugal fan and itsinverter.

Central panel modifications comprising:- Inverter inclusion- START/STOP push-button for filtering unit- Alarm indicator for filtering unit

[Energy saving version]

Logical PID regulation system implemented to the Venturi injector allows consistent spare of processgas energy, comprising:

Δp meter for pressure control to the Venturi injector Modulating Venturi valve Venturi injector and Control panel modification

[Sterilizable version]

As standard our micronization lines are supplied in compact execution for the key process parts, such away that they can be easily sterilized in autoclave. But we can also provide the automated system forthe Sterilize In Place of the complete machine/plant, so that the plant can be sterilized directly inside thesterile clean room, basically we propose three different solutions:

Totally automated system based on Fluent Steam, Totally automated system based on pressurized Fluent Steam, 121°C @1.15 barg inside the

machine with temperature mapping Totally automated system based on hydrogen peroxide solution, this solution allows sterilization

without the use of a pure steam generator

Pure steam generator system is also available for the supply, if required.

Internal polish level of Ra < 0.1 microns for the fluid jet mill Easy to clean and to revalidate Easy to assemble and to disassemble Special bag filters which allows easy cleaning operation Sterilizable spry nozzles Fluid jet mill with open manifold totally sterilizable

[Explosion proof version]

Many pharmaceutical products are potentially explodable in their fine dry powder state, thereforemachine and process system manufacturers have a legal obligation to provide suitably safe andprotected processes to guard against the risk. The technique of explosion protection to be used for aparticular application will very much depend on the explosive nature of the product and also the locationof the equipment. We can supply three different methods of explosion protection:

Containment Inert gas blanketing Venting

Our micronizing systems could be supplied entirely or partly in Atex version.

[Cold / Cryogenic process gas version]

The complete micronizing line could be supplied with a special execution suitable for working with coldprocess gas, generally cryogenic nitrogen. Depending on the sophistication of the micronizing line,many components are completely reengineered in order to guarantee the proper working according tothe process gas temperature and pressure.

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[Process gas feeding line]

Skid mounted system for feeding treated process gas to the jet mill, this system could be supplied inmany different versions, custom done according to client’s requests, for many different fluid media suchas air, nitrogen, with cryogenic system etc...

The system is made up by the following components:

Compressor (screw or oil-free, 40 kW) Dryer and Pressure vessel (storage tank) Reducing valve (with heat exchanger for cold gas / cryogenic version) 5 µm cartridge filter,1 µm cartridge filter, 0.01 µm cartridge filter, Active carbon cartridge filter On-Off main valve

On demand, it is possible to supply each item separated, not skid mounted.

[Additional documentation]

- Additional copies of the project book- IQ-OQ protocols- FAT or SAT protocol- FAT and SAT protocols- Micronization protocol

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4.0 Start-up and Commissioning

The assistance of our technicians is a primary condition for the optimisation of the process of ourmachinery, the cost of this assistance is intended to cover our air tickets and labor of technical people ofours which will give assistance on your site for assembling, installing, starting-up and fine tune up ofyour products according to the check list. At customer’s charge the local hand work, the local hospitality(hotel, board, local travel etc.) for our technicians.

5.0 Guarantee

Tecnologia Meccanica Srl guarantees all the supply against failure due to faulty design and/orworkmanship for a period of 12 months from the date of start-up, but in any case for not more than 18months from the date of delivery of all materials.

Tecnologia Meccanica Srl considers excluded from the guarantee all the parts subjected to normalwear, to chemical and electro-chemical corrosion due to external agents and to damage caused bycustomer’s lack of care or by the use of incorrect raw or auxiliary materials.

The above guarantee means that Tecnologia Meccanica Srl will modify, repair and eventually replacethe defective parts as soon as possible and at its charge, excluding expenses for removal, installation,transport and packing of the original parts and the replaced ones.

Warranties cannot be called upon, if mechanical commissioning on site is not performed by ourtechnicians.

Any other obligation or liability for direct or indirect damages is not included, except for the repairs orreplacement of defective parts as mentioned above.

Our Workshop address:

Tecnologia Meccanica SrlVia S. Cristina 37 - 24048 Albegno di Treviolo –Bergamo –Italy

Telephone +39 035 691320Facsimile +39 035 201175

Electronic mail info@tecnologia.itWebsite www.tecnologia.it

The manufacturer reserves the right to modify specifications without prior notice.