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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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