Medical Products
Medical Products
The scope of medicine devices is incredibly wide-ranging from contact-lens care products to bandages and dialysis machines to catheters.
GfPS is ZLG accredited, meaning that the test procedures performed by GfPS are in accordance with DIN EN ISO/IEC 17025 and Guidelines 93/42/EEC and 90/385/EEC in the areas covering microbiological hygiene testing of medical devices, including sterilisation procedures and environmental monitoring (Registration number: ZLG-P-959.96.02), and this accreditation is recognised throughout Europe.
Our services
- Testing of cleanrooms / room ventilation and air-conditioning systems for on-going compliance with DIN EN ISO 14644 and the Guideline for Good Manufacturing Practice (EU GMP)
- Hygiene-testing of the production conditions and evaluation of the hygiene status
- Quantitative determination of the bioburden according to DIN EN ISO 11737
- Testing for bacterial endotoxins (LAL-Test), Gel Clot and the kinetic turbidimetric methods (Ph. Eur., USP, FDA)
- Microbial differentiation and identification
- Sterility testing according to Eur. Ph., USP, ISO
- Validation, revalidation and performance appraisal of sterilisation processes (irradiation, steam, ETO and plasma sterilisation)
- Cleaning/ disinfection/ conditioning processes
- Validation of disinfection processes e.g. according to DIN EN ISO 15883
- Testing according to the European Pharmacopoeia/ USP
- Testing of the efficacy of antimicrobial conservation
- Testing for the absence of particular microorganisms
- Determination of the total aerobic count
- Testing for bacterial endotoxins (LAL-test)
- Studies into artificial aging of packaging
- Testing of the microbial tightness of packaging (microbial dusting)
- Testing of heat-sealed seams for strength and width
- Microbiological analysis according to the Drinking Water Standard and Eur. Ph.
- Water analysis according to the Table Water Standard
- Swimming and bathing water analyses according to DIN 19643
