Category: Testing Services

Biological Indicators

Standard: European Pharmacopoeia Polish Pharmacopoeia 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 Testing time 3-8 days

Production water

Standard: European Pharmacopoeia Polish Pharmacopoeia Method: membrane filtration Tested product: purified water highly purified water water for preparation of extracts water for injections tesing time 7 days If necessary we can perform Bacterial Endotoxins Test and Identifications of Microorganism.

Microbial Environmental Monitoring Of Clean Manufacturing Areas/Cleanrooms

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 Testing time 10 days If necessary we can perform Identifications of Microorganisms. Analysis of trends If required the laboratory may perform an analysis […]

Identification Of Microorganisms

Standard: European Pharmacopoeia Polish Pharmacopoeia Method: Microscopic technique (gram strain technique) Selective & chromogenic media Biochemical tests Depending on customer requirements we can identify microorganisms to the species or genus.

Sterility Test

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 […]

Bacterial Endotoxins (LAL) Test

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 3-10 sterile medical devices (based on future batch […]

Bioburden Test

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 […]