Standard: ISO 11138-1 ISO 11138-7 internal testing procedures manufacturer’s instructions Method: Control of the steam sterilization process (autoclave) Control of the dry heat sterilization process Control of the radiation sterilization process Control of the EtO sterilization process
Category: Testing Services
Standard: European Pharmacopoeia Polish Pharmacopoeia Method: membrane filtration Tested product: purified water highly purified water water for preparation of extracts water for injections If necessary we can perform Bacterial Endotoxins Test and Identifications of Microorganism.
Standard: Good Manufacturing Practice, EN PN ISO 14644-1 EN ISO 14698-1 PN ISO 18593 Method: Active Air Sampling – volumetric method Passive Air Sampling – gravimetric method (Settle Plates) Contact Plates Swabs If necessary we can perform Identifications of Microorganisms.
Standard: European Pharmacopoeia Polish Pharmacopoeia Method: Microscopic technique (gram strain technique) Selective & chromogenic media Depending on customer requirements we can identify microorganisms to the species or genus.
Standard: ISO 11737-2 – “Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process” Method: Direct immersion – method of choice for medical devices because the device is in direct contact with test media throughout the incubation period. Requirements: Test method validation (Bacteriostasis and […]
Standard: European Pharmacopoeia United States Pharmacopoeia Polish Pharmacopoeia Method: Gel clot technique – method A – limit test Gel clot technique – method B – quantitative test Kinetic-chromogenic technique – method D – quantitative test Requirements: Test method validation shell be performed for each medical device or product family For validation purpose 3 batches of 1-10 sterile medical devices (based on future batch […]
Standard: ISO 11737-1 – “Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products.” Method: Membrane filtration Plate-count (pour-plate method) are used to measure the number of microbes in a sample Requirements: Test method validation shell be performed for each medical device or product family For validation purpose 11 sterile devices For […]