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The KrosFlo® EZ-Bag products are based on a core technology that produces a
state-of-the-art synthetic film to a meet the demands of the bioprocessing industry.
This film used to make KrosFlo brand bags is a multilayer laminate with excellent gas barrier
characteristics; offers great strength and durability, yet is pliable and easy to handle.
The robustness withstands rigorous use as well as irradiation. The following quality tests
are performed during the manufacturing and assembly of the KrosFlo brand bags.
- 100% IPC Leak Tests
- 100% IPC Seal Strength Tests of the Film
- 100% IPC Seal Strength Tests of the Ports and Mounted Components
- 100% Visual Control of Finished Products
- Process Parameter Exposure Criteria (temperature, pressure & time)
All synthetic film products are manufactured in full compliance to
cGMP guidelines in a Class 10,000 cleanroom. The manufacturing
facility meets all requirements for FDA & EMEA, ISO 14644-1,
Class 4 Certification. The film and the KrosFlo brand bags have
passed an extensive validation study. The complete, comprehensive
regulatory and validation file is available upon request.
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Physical Tests
- O2 Gas Transfer (ASTM D-3985)
- CO2 Gas Transfer (ASTM D-1434)
- H2O Vapor Transmission (ASTM E-96-80)
- Elongation & Tensile Strength Tests
- 100% Modulus Test (ASTM D-638)
- Tear Resistance Test (ASTM D-1004)
USP Biologicals / ISO 10993
- Implantation Test (ISO 10993-6)
- Cytotoxicity Test (ISO 10993-5)
- Sensitization Test (ISO 10993-10)
- Irritation Test (ISO 10993-10)
- Acute System Toxicity Test (ISO 10993-11)
- Kinetic LAL (USP 26, NF21, 2003 <85>)
Sterilization Validation
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USP Chemicals
- Material Characterization Study
- USP 26, Physiochemical Testing (<661> "Containers - physiochemical tests - plastic")
EP Conformity Testing
- EP 3rd. Edition, Chapter 3.1.5
Extractables Validation
- Water For Injection (WFI)
- NaOH (pH > 11)
- HCl (pH < 2)
- Ethanol
- NaCl
- PBS buffered Tween
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