Flexsafe® 2D for Fill & Finish
Flexsafe® 2D for Fill & Finish is a single-use system for small batch volume replacing the traditional stainless steel surge tank containing the drug product in the filling area. Flexsafe® enables single use bioprocessing throughout all process steps and all applications all using just one film.
- Item No.:
- Flexsafe-FF
*Custom/bulk order quotes are provided within 72 hours of request.
Small Premium Flexsafe® 2D bags to Secure your Drug Product
- Fits Small Batch Volume for personalized medicines
- Ensures Premium film quality with high assurance of supply and extensive characterization and qualification
- Maximizes product recovery and ease draining thanks to its optimized bag design
- Fast tracks validation work with highly characterized materials
- Provides a complete aseptic processing platform in combination with Biosafe® and SART™ port
With a unique material, Flexsafe® significantly reduces the validation effort and costs
- Extractables and leachable studies
- Toxicological assessment and stability studies
Applications
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Application AreaFinal filling
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Process StepDrug Product Final Filling
Compliance Information
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Lot Release TestingYes
Connections (Physical)
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Connector(s)
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Opta® SFT Connector
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KPC
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Tri-clamp
- MPC
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Opta® SFT Connector
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Line LeakTest100% Leak tested in line
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Port Diameter110 mm if RAFT configuration
Dimensions
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DimensionsDepending on volume range
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Tube LengthUpon request
Features
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Integrity TestedNo
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Number of Lines2 - 6
General Specifications
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Tubing
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Silicone (Tuflux® SIL)
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Silicone (Accusil™)
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Silicone (Liveo® Pharma Advanced Pump Tubing)
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TPE (Tuflux® TPE)
- Other platinum-cured silicone available upon request
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Silicone (Tuflux® SIL)
Materials of Construction
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Film MaterialFilm S80: Polyethylene (PE)
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Tubing Material
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Synthetic Thermoplastic Elastomer
- Platinum-Cured Silicone
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Synthetic Thermoplastic Elastomer
Product Information
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BrandFlexsafe® 2D
Sterility/Purity
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Delivery ConditionSterile
Volume
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Volume Range3 L - 20 L