Aseptic clarification and purification of vaccines and monoclonals.\nAntibodies, recombinant proteins, and plasmids.\nAseptic cell processing.\nEnvironments where terminal sterilization is not feasible.\nPreclinical through Phase II clinical trials.\nAreas where the risk of cross contamination is high Fast Trak drug development processes.\nSmall to midsize CMOs, biotech, and biopharmas seeking lean solutions or having concerns about crosscontamination in preclinical, Phase I and Phase II trials.
Certificate of Analysis
Yes
Sterility
Each component is sterile for all fluid-contact surfaces (per AAMI TIR 33:2005 and the principles of ISO/AAMI/ASTM 11137-1:2006)
Animal Free Compliance
Animal-free origin for wetted parts per EMEA/410/01 (alternatively-manufacturing under denaturing conditions).
Endotoxin
For process fluid contact surfaces, endotoxin level is < 0.25 EU/mL using water extraction method.
Hemolysis Testing
Hemolysis, ISO 10993-4
Material Compliance
USP Biological Safety, Class VI for wetted parts, USP 88 plastics requirements and FDA 21CFR177.1520
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