Know what’s inside:
Microbiology and Molecular Biology
Microbiology
New Services (cGMP)
- Performing Chromogenic Assays (e.g. Heparin according to Ph.Eur. 2.7.5 and USP <208>; ELISA for Penicillins)
- Endotoxin Testing according to Ph.Eur. 2.6.14 (Methods C, D) and USP <85> using Turbidimetric and Chromogenic Methods
- Microbiological examination of nonsterile products: Tests for Burholderia cepacia complex in accordance USP<60>
- TOC (total organic carbon) in accordance Ph. Eur. 2.2.44, USP <643>, JP und KP
Tests in accordance with Ph.Eur. (cGMP)
- Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests acc. to 2.6.12
- Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms acc. to 2.6.13
- Microbial Examination of Herbal Medicinal Products for Oral Use and Extracts Used in Their Preparations acc. to 2.6.31
- Bacterial Endotoxins acc. to 2.6.14 (Method A)
- Microbiological Assay of Antibiotics acc. to 2.7.2
- Efficacy of Antimicrobial Preservation acc. to 5.1.3
- Water, Purified (Aqua purificata; Monograph 0008)
- Water for Injection (Monograph 0169)
- Water for Preparation of Extracts (Monograph 2249)
Tests in accordance with USP (cGMP)
- Chapter <51> Antimicrobial Effectiveness Testing
- Chapter <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Test
- Chapter <62> Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms
- Chapter <81> Antibiotics-Microbial Assay
- Chapter <85> Bacterial Endotoxins Test
Additional Services
- Product-Specific Validations (acc. to Ph.Eur. and USP)
- Development and Validation of Rapid Test Methods (e.g. Simplate®)
- Microbial Assay of Vitamins
- Identification of Germs
Microbiological Tests - Hygiene Monitoring (cGMP)
- Sampling by Trained Stuff
- Investigation
- Germ Identification to Genus Level (Identification on a Species Level can be done via Subcontracting)
- On request we can supply the necessary additional information about detected bacteria and their possible sources of contamination
Molecular Biology
- Cell-based tests / biological activity tests
- Cell migration assays
- Cell proliferation/inhibition assays
- Binding and/or competitive assays
- Monocyte activation test (Ph. Eur. 2.6.30)
- Enzyme-linked Immunosorbent Assay (ELISA)
- Residual Host Cell Protein Assays (HCP) with ELISA (e.g. according to Ph. Eur. 2.6.34)
- RNAse/DNAse through Gel electrophoresis
