The senetics biological laboratory supports you in all aspects of biological safety, from bioburden tests to cleanroom monitoring. We check your medical technology products on for example biocompatibility or bacterial endotoxins. Of course, your products will be tested according to the latest standards.
- You would like to identify the germ load of your product after production or to validate your sterilization processes?
- You want to ensure the biocompatibility of your products?
- There are endotoxin exposure limits for your product that you would like to test?
- Are the limits for particles and germs in your clean rooms met?
- Your medical device does not meet the standard and need for an individual test scenario?
Our qualified staff ensures the biological safety of your products!
The following services are offered by senetics BioLabs for you:
Tests for sterility:
- Sterility and bioburden tests according to DIN ISO 11737
- Total germ count on products and germ identification (PCR, Gram stain, etc.)
Biocompatibility according to DIN EN ISO 10993:
- Testing for mutagenicity according to DIN EN ISO 10993-3 (Ames test)
- Cytotoxicity according to DIN EN ISO 10993-5
- In vitro tests for skin irritation according to DIN EN ISO 10993-10
- Endotoxin test according to Ph. Eur. 2.6.14 (LAL test)
Cleanroom monitoring according to DIN EN ISO 14644, VDI 2083, GMP, DIN EN ISO 14698:
- Monitoring of particle and total germ count
- Hygiene and behavioral training, risk avoidance
Cleaning and Sterilization Validation:
- Control and Validation of the cleaning and sterilization
- Effectiveness of disinfectants
- Maintenance of sterility according to DIN EN ISO 11737-2
Antimicrobial effectiveness of surfaces and textile:
- Antimicrobial effectiveness according to JIS Z 2801 & ISO 22196 and without liquid
- Testing of textiles in accordance with DIN EN ISO 20743
If you have any questions about our services, don´t hesitate to contact us! We are happy to help you.
Further information can be found on the website of BioLabs.