Pharmaceuticals
Information concerning pharmaceuticals
The pharmaceutical industry has traditionally high standards in quality. We offer reliable support to our customers from the pharmaceutical areas to enable them to achieve their objectives.
GfPS is GMP-certified – The GMP-Certificate is an attest that we strictly adhere to the requirements of the EU Guidelines to the Good Manufacturing Practice of Medicinal Products as a pharmaceutical testing laboratory as described in § 14 (4) of the German Medicines Law (Arzneimittelgesetzes: AMG) for microbiological quality control testing, in particular sterility and endotoxin tests, and thereby the requirements of the EU-Guideline for the Good Manufacturing Practice for Medicines.
Our services:
- Testing of cleanrooms / room ventilation and air-conditioning systems for ongoing complience 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 (Eur. Ph., 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
