Numer katalogowy: WAK-DEX40-25

 

CryoSure-DEX40

 

55% w/v Dimethyl Sulfoxide USP Grade, 5% w/v Dextran 40 USP Grade Cryo-Preservative in Multidose

Registered as medical device product in EU for storage of human cells or tissue for transplantation to Medical Device Directive 93/42/EEC.

 

Registered as medical device in EU for storage of human cord blood according to Medical Device Directive 93/42/EEC.

 

Features:

- Raw materials are of USP grade according to cGMP and ICH guidline Q7A (precondition to use a substance as an API);

- Aseptic filling according to GMP and DIN EN ISO 13408;

- Primary packing materials are designed to withstand the strong polar solvent DMSO (covered by stability studies);

- Final testing of confectionated products exceeding USP & EP requirements in e.g pyrogens, mycoplasma and identity;

- The product is tested according to European and United States Pharmacopea for Sterility, Pyrogens, Endotoxins, Mycoplasma & Vitality;

- Containers Fitted with Flipoff-Tearoff Closures.

 

8 ml Multi-dose

25/case

 

WAK CryoSure-DEX40