SteriPack Poland offers Microbiological Testing Services for Medical Devices within the scope of ISO 13485:2003 performed in ISO 6 & ISO 7 class environments ensuring products are safe and meet Regulatory Compliance.
Microbiological Testing of Medical Devices and Packaging
- Bioburden Testing of a non sterile product according to EN ISO 11737-1. Test Technique involves membrane filitration or plate count/pour-plate
- Identification of Microorganisms (Genus and Species) according to EN ISO 11737-1. Test Technique involves biochemical test API, microscopy technique
- Sterility Testing according to EN ISO 11737-2 . Test Technique involves direct immersion or membrane filtration
- Bacterial Endotoxins Test (LAL) according to European Pharmacopoeia <01/2010:20614> or USP <85>. Test Technique involves Gel Clot Technique
Microbiological Contamination Monitoring of Cleanroom Work Space, Equipment, Personnel, Safety Clothing
- Quantitative Test for Total Viable Count according to EN ISO 14644-1, EN ISO 14698-1, EN ISO 14698-2, GMP
-Air Tests Available - Volumetric/settle method/contact plate method/swab method
Microbiological Testing of Water
- Total Viable Aerobic Count Test according to European Pharmacopoeia <01/2009:008>
- Water for Testing- Purified Water or Water in Process
