Medistri SA

Medistri AG is a company that specialises in the field of sterilisation: we put together the required packs, advise you and carry out a wide range of tests in the pharmaceutical and medical device sectors. We take particular account of the specific environmental requirements for the manufacture of medical devices, such as sterile rooms, etc. Our test laboratory is accredited in accordance with STS 504 and offers a range of specialised services. These include the following topics in particular:

• Microbiology, biocompatibility, product development support.

• Biocompatibility: tests on the product itself in accordance with the applicable regulations.

• Cleaning validation for the sterilisation of reusable devices. Validation of packaging. Sterilisation validation including the associated testing. Search for residues TOC, VOC, EO, ECH ...)

• Microbiology and sterilisation: control of sterilisation by determining the microbial load, detection of defined germs, search for bacterial endotoxins, sterility tests, standardised biological indicators, personalised biological indicators ...

• Cleanroom monitoring: tests in a controlled environment, such as particle detection, air analyses, microbiology, surface analyses. Personal hygiene of employees (microbiology). Analyses, detection of existing germs, tips for better control of processes. Qualifications of incubators.

• Product control: definition of sampling plans (quantity, frequency) and associated controls based on microbiological analysis; research into released particles including classification by size, detection of endotoxins, packaging analyses, etc.

• Packaging control: validation of the packaging (accelerated ageing in the incubator, transport simulation, fulfilment of physical and microbiological requirements, detection of released particles including classification by size)

• Production of medical packs: Packaging of medicinal products and medical devices, including definition of the associated controls

• Consultancy: Support for start-ups, from the initial production phase to CE marking

Team:

The laboratory consists of four qualified people: technical laboratory technicians (chemistry, biology) and biologists (microbiology, cell culture)

Strengths:

Medistri is a one-stop shop: we provide all the services required to develop and successfully market a product. From the first tests to production and release on the market.

Instrumental equipment:

Biology unit with cellular to be finalised

Complete microbiology unit

Complete molecular biology unit

Incubator for accelerated ageing

Temperature sensors, for humidity and pressure

ISO 7 clean room with laminar flow

Gas phase chromatographs (HS injection and liquid), FID detector

Liquid particle counter (light turbidity)