Fresh Thinking in Flexible Film API Containment
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Fresh Thinking in Flexible Film API Containment
- 1. FLEXIBLE CONTAINMENT SYSTEMS March 2016 1Copyright and Intellectual Property notice: All designs, knowhow and concepts shown in this presentation are the property of Solo Containment Ltd and may not be shared to any third party without written permission © Solo Containment 2015 See the video: https://www.youtube.com/watch?feature=player_embedded&v=Ac9zDQPKe4Y
- 2. Our Background in Containment Technology: • Founded containment company Extract Technology in 1981 • Developed “Downflow Powder Handling booth” in 1984 • Detailed surrogate API challenge to downflow booth 1989 • Carried out “Containment Hierarchy” testing of booth technology – then booths + work stations – then barrier isolation system 1991 • Established Containment Strategy Pyramid based on risk & hazard in 1996 • Solo Containment founded 2011 – Objective: Develop Superior Flexible Film Containment Technology Solo is based in the UK – 14 employees – ISO9001 – Produce 50 to 60 flexible enclosures every month We were instrumental in ISPE SMEPAC
- 3. We are a small dedicated team Solo Ship weekly to the USA – Asia and Europe 3
- 4. Flexible Film Containment Technology…. Does it work? soloFLEXIsolator challenge: 10Kg API transfer x 3 runs
- 5. Isolator + HEPA exhaust + Installation + IQ/OQ €14,000
- 7. Isolator + HEPA exhaust + Installation + IQ/OQ €23,000
- 8. As with any containment system – SOP’s and maintenance are key to long term safe operation. As we review this test data it is clear that a well designed flexible film isolator will operate at the same performance standard as a classic stainless steel isolator. The system Solo Containment offer is a flexible film isolator – engineered to rigid stainless steel isolator standards • Negative pressure cascade in API handling chambers • Multi stage HEPA filtration • Consideration to contamination free HEPA filter service and enclosure change over
- 9. Comparison between classic stainless steel & Flexible Film Isolators Stainless Steel Flexible Film Cost €150,000? €20, to 30,000? Operating Cycle 10-15 years Frame 10-15Yr Enclosure 1- 4Yrs (campaign Use?) Containment Performance Effected by transfer coupling or RTP performance sub 1.0µg/M³ sub 1.0µg/M³ Ergonomics OK if mock-up tested Easy to change Chemical Resistance High resistance Reasonable resistance Cleaning validation Anticipate high cost for CIP system validation Disposable Delivery to Site 24 weeks 6 to 8 weeks
- 10. 10 Solo Containment Safety Features: Your guarantee of right first time performance Aseptic -Lab Anerobic –Lab OEB3 (50-10µg/M³) OEB4 (10-1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator + SOP Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade +SOP 3 step continuous liner operation +SOP 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push- push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber +SOP RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure SoloHardwareSelection These “Hardware” Selections are backed up with a complete range of validation options: • Ergonomic Validation with full scale mock-up review on clients site • Detailed equipment specifications and / or URS • FAT at Solo facility • Surrogate API challenge during Solo FAT • Development of SOP’s • SAT • IQ/OQ • Site Surrogate API challenge Specification: The Key to reliable Containment Performance:
- 11. Flexible Film Containment and ATEX Classifications
- 12. Flexible Film Containment and ATEX Classifications Polyurethane Film FPU 80 AS is considered suitable for ATEX zone 21
- 13. 13 Specification: Let’s look at some examples: Negative Pressure Enclosure around Granulator OEB 3 Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure
- 14. 14 Specification: Let’s look at some examples: Drum to Ezi-Dock Isolator OEB 3 Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure
- 15. 15 Specification: Let’s look at some examples: Clinical Trials Dispensing Isolator OEB4 Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure
- 16. 16 Specification: Let’s look at some examples: Oncology Product Re-Pack Isolator OEB5 Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure
- 17. 17 Specification: Let’s look at some examples: Enzyme Research Process Train Isolator OEB5 Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure
- 18. 18 Specification: Let’s look at some examples: High Potency Tablet Blister Line Isolator OEB5 Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure Acrylic Ezi-Dock
- 19. 19 Specification: Let’s look at some examples: Disposable Aseptic Small Run Vial Filling Aseptic -Lab Anerobic –Lab OEB3 (50- 10µg/M³) OEB4 (10- 1.0µg/M³) OEB5 (1.0- 0.01µg/M³) Heavy Duty PVC Enclosure FDA rated PU Film Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry Two Chamber isolator Gas tight acrylic pass box : Compression Gasket Inflatable gasket Multi-Chamber with pressure cascade 3 step continuous liner operation 6 step continuous liner operation Cuff mounted 3 groove safe change gloves Cuff mounted Push-push safe change gloves Contained Coupling Powder Transfer Contained Coupling Powder Transfer with secondary containment chamber RTP contained transfer bagged materials Manual variable speed fan Automatic speed control fan ATEX Fan option Filter condition / Leak test alarm 99.95% Effy P3 Breather filter Screw Mount HEPA Push-Push safe change HEPA Nitrogen inertion via PALL filter Grade A environment in fill chamber Gamma Irradiated Enclosure
- 20. Solving Containment Issues with Alternative Methods