Registered as medical device product in EU for storage of human cells or tissue for transplantation to Medical Device Directive 93/42/EEC.
- 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;
- Final testing of confectionated products exceeding USP & EP requirements in e.g pyrogens, mycoplasma;
- Containers Fitted with Flipoff-Tearoff Closures.
- Additional Information
SKU WAK-DMSO-10 AMPUL Tax Class 9% Brand WAK-Chemie