Sterility testing

Micans offers sterility testing before distribution to users of products that are sterilized after manufacture. The inspections are carried out in accordance with Ph Eur 2.6.1 / USP <71> in LAF (Class II Laminar Flow Biological Safety Cabinets) benches. We continuously check air and surfaces in premises, LAF benches, on equipment and staff clothing to ensure that our hygiene requirements are met.

Sterility testing of solutions is normally performed by direct inoculation into two different culture broths and these are checked for any growth after 14 days. TSB (Tryptic Soy Broth) is used for testing aerobic microorganisms including fungi when incubated at 25 ° C. Thio (Thioglycollate Broth) is used for testing both aerobic and anaerobic microorganisms and is incubated at 35 ° C. Solid materials are also inoculated into the culture broths. As an alternative to direct inoculation with large volumes of filterable product, or if substances that inhibit the growth of microorganisms are present, a membrane filter method can be applied.

Micans' laboratory is:

ISO 17025: 2018 (SS) accredited by Swedac (id 10351)
ISO 9001: 2015 certified by A3 cert (id 1565)
ISO 14001: 2015 certified by A3 cert (id 1565)

For details, see Quality and environment

Micans' laboratory complies with OECD principles of good laboratory practice (GLP), ENV / MC / CHEM (98) 17

Feel free to contact us for questions, prices and more details.