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:

Laboratory testing

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

Further services

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

Our strengths

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
GMP-Auditbericht

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.

Contact:
Dr. Bernhard Fellenberg | phone: 0781-96 94 7-194 | email: bernhard.fellenberg@bav-institut.de