Puncture resistant, gas diffusion control, and flexibility Exceptional optical clarity, strength, and cleanliness
Compliance
Film compliant with USP Class VI requirements and ADCF
Manufacturing Environment
Manufactured in ISO Class 7 cleanrooms
Volumes
50 mL, 100 mL, 250 mL, 1 L, 5 L, 10 L, 20 L, 50 L
Port Locations
End ported, boat fitment
Tubing Material
TPE and Silicone
Connector options
Luer connectors, Quick Connectors and Aseptic connectors and, others (available upon request)
Filters
Brand of your choice
% Liquid Recovery (WFI)
> 99.9%
Compliance
Manufactured in a controlled environment (Class 10,000) Manufactured under Quality management system certified to ISO 9001 Validation include testing for: Integrity testing, Validation Guide for Bag film & Bag Assembly
Sterilization
Gamma irradiation, 25-40 KGy
Manufacturing
Under cGMP protocols in ISO Class 7 cleanroom conditions.
Traceability
Full traceability of all components.
Packaging
Clean and double-bagged. Packaging has labels with: Gamma indicator, SKU, description, expiration date and batch No.