BAV-Institut — Quality control 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 tests

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 test 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 tests
Environmental investigations and monitoring

Quality control for pharmaceutical and medical products manufacturers

Further services

Company and hygiene inspections
opinions and expert opinions
In-house/on-site training and events
Express sample collection
Sampling on site
Free online sample portal

Your advantage

Our Strength

fast and reliable
Experienced and competent employees
Personal contacts and very good accessibility
Broad range of analyses and global networking
Member of the Tentamus laboratories www.tentamus.com

Your security

Our quality standards

GMP confirmation (Regierungspräsidium Tübingen)

Successfully passed FDA audits

Approval according to §44 Infection Protection Act

Permit according to §3 Narcotics Act (BtMG)

Accreditation in accordance with DIN EN ISO 17025 for the testing of medical devices

GMP-Auditbericht

Convince yourself of our services. We would be happy to make you a non-binding and attractive introductory offer.

Our institute supports you with fast and reliable laboratory results and competent advice.

Your contact person:

Dr. Bernhard Fellenberg

Phone: 0781-96 94 7-194
bernhard.fellenberg@bav-institut.de