Cohn Fraction V Paste

Fraction V Paste from Cohn Fraction V cold ethanol plasma fractionation
Product # PS520

• Made from plasma of US origin collected from qualified human whole blood or source plasma donors at Blood Establishments with a current valid FDA Registration Certificate, collected according to FDA guidelines.
• Paste material manufactured according to documented procedures and GMP guidelines.
• Labeling
  • Each paste unit will be labeled with product description and batch lot number.
• Appearance
  • Yellow to brown in color, free of particulate matter.
  • The individual plastic bag contents homogeneous in color and consistency with no unusual odor other than ethanol.
• Included with each shipment:
  • Signed Certificate of Compliance with the following information:
  • Certification of testing:
    • Each donor unit used in the production of the paste has been tested by an FDA licensed laboratory with FDA licensed test kits.
    • Test results Negative or Non-Reactive for HBsAg, anti-HBc, anti-HIV 1/2, anti-HTLV I/II,
      anti-HCV, and Syphilis, HIV -1 RNA and HCV RNA. Results for other viral tests if performed such as HBV NAT, West Nile Virus and Chagas (T. cruzi) Negative or Non-Reactive.
    • In addition, the plasma may be tested by PCR for HAV, HBV, HCV, HIV and Parvo B-19.
  • Certification of Storage Temperature: The paste has been stored at -20 C or below.
  • Certificate of Analysis: Analysis of paste: Batch number, pH, total protein, albumin and globulin levels, weight of the paste batch supplied.
• Packaging
  • Plastic bags packed in boxes with insulation material and dry ice
• Shipping
  • Depends on customer specification.
  • Transported to storage facility or final destination by freezer truck.
  • Can be air-freighted in containers with dry ice.
  • Next Day Delivery by Federal Express with dry ice
• Order Lead Time
  • Depends on required quantity. Contracts and Standing Orders available.