VDMA OPPI Seminar Polymer material handling solutions for medical products. Srikanth, , motan India

Transcription

1 VDMA OPPI Seminar Polymer material handling solutions for medical products

2 Basic Requirements In Medical & Pharmeceutical Applications

3 Ground rules in material handling Typical polymers: PA, PET, PEEK, PC, PLLA / PDLA Consumption / machine: kg/h Emission free (Clean room) No dust No compressed air (pneumatic) Contamination free (Material) No particle ingress No cross contamination Silicone free Documentation traceability Process parameters Material flow for delivery to product Reinhard Herro, Isny - Germany

4 Emission Free Cleanroom Material Handling Systems

5 Definition of cleanroom classes Standards US Federal Standard 209 E DIN EN ISO US Federal EN ISO Partikel Particle 0.5 0,5 µm Particle 0.5 0,5 µm Standard 209E pro per cbft ft³ pro per m³ US FS 1 ISO Klasse US FS 10 ISO Klasse US FS 100 ISO Klasse US FS ISO Klasse US FS ISO Klasse US FS ISO Klasse

6 Concept 1: Shop floor itself is the cleanroom Packaging e.g. cleanroom 10,000 Assembly

7 Concept 2: Room in room e.g. cleanroom 10,000 Packaging Conveyor belt Assembly e.g. cleanroom 100,000 or ambient air

8 Concept 3: Combined cleanrooms e.g. cleanroom 100,000 or ambient air Packaging e.g. cleanroom 1,000 Assembly cleanroom 10,000

9 Contamination Free Material Handling Systems

10 Material loading from Big Bags Gas-tight connection HEPA filter or closed-loop air circuit

11 Material loading from octabins HEPA filter or closed-loop air circuit Saugrohr Suction tube Octabin sealed with film

12 Material loading from sacks (debagging station) Pieces of film or other sources of contamination (sack surface) HEPA filter or closedloop air circuit

13 Material loading from big bags, octabins and sacks Points to consider Granules should be stored in the closed container This is Big Bag easy Octabin Sack difficult HEPA filters at the suction box or telescopic suction tube Drawing in the air from closed-loop system

14 Material Handling System Concepts

15 Material loading, coupling station and drying bin in the cleanroom Ambient air Vacuum valves e.g. cleanroom 10,000 Vacuum lines motan motan motan Machine 1 Machine 2 Machine 3 Filters Risk of contamination!

16 Storage and drying of material outside the cleanroom open-loop air circuit Ambient air Vacuum valves e.g. cleanroom 10,000 Vacuum lines motan motan motan Octabin closed Machine 1 Machine 2 Machine 3 Filters

17 Storage and drying of material outside the cleanroom closed-loop air circuit Ambient air Vacuum valves e.g. cleanroom 10,000 Vacuum lines motan motan motan Octabin closed Machine 1 Machine 2 Machine 3 Filters

18 Good Material Handling System?

19 What makes a system good? Minimum conveying speeds (< 20 m/sec) -> reduced dust levels Oil free vacuum pumps / blowers outside cleanroom Dryers, bins etc. outside, only duct work going inside As few moving parts in the cleanroom as possible Parts in contact with polymer (food grade) SS or glass Pipes flanged, if necessary No seals in contact with polymer Easy to clean separators (removable) and resistant to solvents Dry-air conveying - drying bin machine, incl. evacuation Purge after every conveying cycle Everything properly earthed for electrostatics

20 Every air intake point should have a filter! HEPA High Efficiency Particulate Air Class H14 - Separation η 99.97% for > 0.3 μm particles ULPA Ultra Low Particulate Air - Separation η % for > 0.12 μm particles < 0.1 trapped by diffusion; > 0.4 by inertial impaction For pressure compensation / implosion at the vacuum valve At all suction points suction box / suction tube closed-loop air circuit Filter screens with a mesh size of 1,200 µm for better separation of dust in the hopper loader

21 HEPA / ULPA filters

22 Schematic of a good cleanroom material handling system AMBIENT AIR CLEANROOM Implosion filter Blower Blower filter filter Dry-air conveying with evacuation

23 Encapsulated cell for manual material loading

24 Cleanroom Conveying : Filters Air intake filter Process filter

25 Cleanroom Conveying : Filters Air intake filters

26 Cleanroom Conveying : Glass or SS Vacuum Loader Earthed systems

27 Cleanroom Conveying : Flanged piping

28 DQ FDA GMP IQ OQ PQ How does a qualified / validated system look?

29 Validated system! SS piping in trench / supported, PU hose

30 Validated system! Everything in contact with polymer in SS / glass

31 Validated system! Small machine loaders in glass

32 How to qualify / validate? The SYSTEM validation process Time at customer, IQ, OQ, PQ approx. 6-8 days Time for qualification Production protocols on conclusion DQ, IQ, OQ, PQ approx. 8 days Time for production of GMP / FDA conform documentation approx days Requirements Conclusion Qualification report System Qualification DQ (Design Qualification) IQ (Installation Qualification) OQ (Operation Qualification) PQ (Performance Qualification) GMP/FDA conformity documentation Life cycle model Description of the system from the user specification (system requirements) up to disposal Production of a qualification report/plan normally from customer Comparison of requirements from specification with the delivered system All 22 documents must have the same visual design, sides must be consequently numbered, each document must have a contents and any changes must be documented Qualification is the documented conformation, that the system function according to the specification!

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34 A PARTNERSHIP FOR LONGTERM COLLABORATION. We are the ideal partner for the plastics manufacturing, processing and chemicals industries. We seek your input at every stage, from development to project planning to implementation. Making sure you get exactly what you wanted from us.

35 THE EXPERTISE TO SOLVE YOUR PROBLEMS Expertise means focusing on what we're good at. We know that we can find a way, even where others might give up. It's no coincidence that we're the world's leading provider of solutions for dosing and mixing, conveying and drying.

36 CUSTOMER-FOCUSED. YOU CAN COUNT ON US At motan-colortronic, service is more than a word. It's a mindset. It doesn't end when you buy one of our solutions. Instead, we aim to develop a genuine partnership. One that creates real value.

37 TRIED AND TESTED OUR TECH CENTRES motan-colortronic operates a Technical Centre in each and every sales region. At these centres, we conduct material and product trials for customers, developing solutions for specific process applications.

38 Injection moulding Blow moulding Extrusion Compounding In-Line Chemistry HOME A LEADING PROVIDER motan-colortronic is number one in injection and blow moulding and a leading provider of extrusion solutions. Thanks to our expertise in compounding, we have developed exceptional knowledge and skills in In-line systems. That means we can deliver the rapid switchover of materials and precise dosing of small batches that these require.

39 motan locations with production motan locations sales & service partners AT A LOCATION NEAR YOU. ALL OVER THE WORLD. With production facilities in the USA, Germany, India and China as well as sales offices in over 70 countries

40 A NETWORK THAT YOU CAN RELY ON.

41 More questions?? Feel free to contact Srikanth Rajesh Katyal

42 THANK YOU FOR YOUR ATTENTION.