Microbiology

Microbiological Quality Control

We offer our customers comprehensive microbiology services for the testing of drugs and medical devices as well as for environmental monitoring, water samples, and production safety.

Tests can be carried out under GMP, GLP or ISO regulations. Our microbiological test systems can be used for the quality control of raw materials, bulk goods, finished products and testing during storage studies as well as for the validation of your plant and the production process. Due to their in-depth knowledge of current guidelines (ISO, DIN, EN, Pharmacopoeia, AAMI, ANSI, ASTM etc.) and regular participation in international working groups and congresses, our experts are always up to date with current trends and regulatory issues. Regardless of whether your requirements are manageable or complex - we can help youto overcome a bottleneck, a particular problem or serve regularly as your external microbiological laboratory to strengthen your fast release of your products. 

Our Services

We are able to offer any microbiology test required in pharmaceutical industry using our global network of Eurofins BPT global laboratories:

• Bioburden of Starting Materials, Intermediates, Consumables and Medical Devices (Bioburden, TAMC/TYMC, Pharm. Eu. 2.6.12 And 2.6.13, USP <61> und <1111>)

• Container Closure Integrity Testing (CCIT)

• Evaluation of Bioinidcators

• Hygiene Monitoring - Microbiological Environmental Control

• Incubation and Evaluation of Mediafill Samples

• Microbial Identification (MALDI-Tof or 16SRNA / ITS2 Sequencing)

• Microbial Limits Tests (USP <61>)

• Monitoring of Water Samples (Distilled Water, Purified Water, WFI) according to Pharmacopoeia Specifications

• Monocyte Activation Test - In Vitro Pyrogen Test

• Mycoplasma Testing

• Sterile and Non-Sterile-Products according to Variouse Pharmacopeia (EP, USP, JP and many more)

• Sterility Testing (Pharm. Eu. 2.6.1 And 2.6.27, USP <71>)

• Total Organic Carbon (TOC)