Services

Since 1987, we have been offering testing of food, medical devices and raw ingredients in accordance with pharmacopoeia regulations (USP, Ph. Eur.) and DIN EN ISO. Areas of the laboratory:

• Analytical Laboratory
• Physical Laboratory
• Sterile laboratory (qualified area accord. to DIN EN ISO 14644 and EU GMP Annex 1)
• L2-Laboratory

Qualifications of the laboratory:

• ISO 9001:2015
• Good Manufacturing Practice (GMP): The laboratory is monitored by the RP-Darmstadt and meets the requirements of the Medicinal Products and Active Ingredient Manufacturing Ordinance as well as the EU-GMP Guideline of Good Manufacturing Practice for quality tests:
  • Microbiological: Sterility
  • Physico-chemical tests
  •  Biological tests
  • Endotoxin tests

• DIN EN ISO/IEC 17025:2018
  • Test area: Drugs and active ingredients
  • Test types: Bacterial endotoxin test, Sterility, contamination tests (particle count, microbiological examination of water).