CRYOFIT DMSO

Since 2021, we have been filling the CryoFit DMSO branded and CE-marked product using aseptic filtration in our ISO 7 cleanroom and ISO 5 laminar flow cabinet.

The tests performed on our products as part of the EC conformity assessment are as follows:

1- Biocompatibility Tests

- Acute Systemic Toxicity Test

- Subacute Systemic Toxicity Test

- Genotoxicity Test

- Hemolytic Effect Test

- Pyrogenicity Test

- Skin Irritation Test

- In Vitro Cytotoxicity Test

2- Chemical Analysis Test (for Purity Determination)

3- Chemical Tests

- Oil Residue Test before and after Washing

- Total Organic Carbon Test after Washing

4- Microbiological Tests

- Bioburden Test before and after Washing

- Bacterial Endotoxin Test after Washing

5- Stability Tests

- Accelerated Aging Test

- Leakage Test

- Sterility Test

6- Clean Room Tests