Quality inspections for
pharmaceutical and medical products manufacturers
Pharmaceuticals and medical devices must meet high quality criteria.
The microbiological safety of these products and formulations is of central importance here. The European Pharmacopoeia (Ph.Eur.) as well as the Medical Device Regulation specify the criteria for this.
We support you with the following services:
- Determination of reproducible microorganisms (TAMC and TYMC) according to Ph. Eur. 2.6.12
- Detection of specified microorganisms according to Ph. Eur. 2.6.13 and 2.6.31
- Bioburden testing according to ISO 11737
- Testing for sufficient antimicrobial preservation
- Product-specific suitability tests (validations)
- Testing according to Ph.Eur, USP and customer specifications (method development)
- Water testing
- Environmental testing and monitoring
- Plant and hygiene inspections
- Statements and expert opinions
- Training and events in-house/on-site
- Express sample collection
- On-site sampling
- Free online sample portal
- Fast and reliable
- Experienced and competent staff
- Personal contact persons and very good accessibility
- Broad spectrum of analyses and worldwide networking (member of Tentamus Laboratories, www.tentamus.com)
Our quality standards
- GMP confirmation (Regierungspräsidium Tübingen)
- Successfully passed FDA audits
- Permission according to §44 Infection Protection Act
- Permission according to §3 Narcotics Act (BtMG)
- Accreditation according to DIN EN ISO 17025 for the testing of medical devices
Convince yourself of our services. We would be pleased to submit you a non-binding and attractive introductory offer.
Our institute supports you with fast and reliable laboratory results as well as competent consulting.