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CryoSure-DEX40

CryoSure-DMSO (55% w/v Dimethyl Sulfoxide, 5% w/v Dextran) is a cryo-protective agent (USP grade) in multidose. It is registered as medical device product in the EU for storage of human cord blood to Medical Device Directive 93/42/EEC.

Features:

  • USP grade, according to cGMP (current Good Manufacturing Practices) and ICH (International Conference on Harmonisation) guideline Q7A (precondition to use a substance as an API (active pharmaceutical ingredient)).
  • Aseptic filling according to GMP and DIN EN ISO 13408.
  • Primary packing materials are designed to withstand this strong polar solvent.
  • Final testing of confectioned products exceeding USP & EP requirements in e.g pyrogens, mycoplasma.
  • The product is tested according to European and United States Pharmacopea for Sterility, Pyrogens, Endotoxins, Mycoplasma & Vitality.
  • Containers Fitted with Flipoff-Tearoff Closures.

Area:

Hematology, Preanalytical

Technology:

Brand:

Documents:

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