Here at MySteriLab, we offer the following testing services for medical devices in ISO 17025 accredited lab: o BIOBURDEN "Sterilization of health care products - Microbiological methods. Part 1: Determination of a population of microorganisms on products" (PN-EN ISO 11737-1), o STERILITY "Sterilization of health products - Microbiological methods. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process" (PN-EN ISO 11737-2), o BACTERIA ENDOTOXINS TEST (LAL test) (European Pharmacopoeia - Ph .Eur., Polish Pharmacopoeia – FP, United States Pharmacopeia -USP & National Formulary (NF)), o Purified water (European Pharmacopoeia – Ph. Eur.), o Biological indicators “Sterilization of health care products - Biological indicators - Part 1: General requirements” (PN-EN ISO 11138-1 and internal SOP), o Microbiological monitoring (internal SOP). With focus on sterile barrier system (SBS) MySteriLab also offers seal integrity testing (in accordance with “Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2”): o Bubble (ASTM F2096), o Peal (ASTM F88), o Dye penetration (ASTM 1929 and EN868), o Transportation (ASTM D4169 | ISTA Procedures 1, 2, 3), o Conditioning, accelerated and real time aging (ASTM F1140 and ASTM F2054). Our microbiological experts are here to help you during testing method settlement and throughout the order process. Now, you can count on our credibility and KNOW-HOW that are confirmed by certifications attests, and validated approvals. You can take advantage of our 20+ year experience in medical device industry as MySteriLab is a part of SteriPack Group.
