Lab Capabilities at their best
Reliability and quality are our promises - through consistent performance and high standards, together we secure the trust of our customers.
Our quality assurance is supported by our in-house chemical-physical laboratory, which tests raw materials and finished products according to pharmacopoeial specifications, and our microbiological laboratory, which ensures sterility and low microbial load, as well as controlled endotoxin levels, essential for parenteral use. Both laboratories are critical in ensuring that all product specifications are met, with stringent controls that address relevant parameters. Beside our inhouse testing capabilities we also hold agreements with external GMP qualified lab partners.
Our Analytic Services at a glance
- In-house chemical/physical analytical laboratory
- Testing of starting materials according to pharmacopoeia (e.g. EP, BP, USP, JP, ChP)
- Finished product testing (e.g. appearance, pH, conductivity, density, refractive index, osmolality, assay)
- Microbiological testing (e.g. sterility, endotoxins, RNase, bioburden)
- Stability testing
Microbiology Laboratory
Ensuring Continuous Microbiological Monitoring: The lab support and ensure microbiological limit testing of our customised GMP-compliant sterile buffer solutions as well as multi-compendial raw materials, essential for our business partners who develop and produce biopharmaceutical based drug substances and drug products as well as biologically based products, such as plasma-derived medical (PDMPs) products.
Uncompromising Quality Standards: Ensuring strict microbiological compliance for raw materials, as well as process- and buffer solutions, through in-house testing of Endotoxins and Bioburden (TAMC/TYMC) in a cleanroom environment.
Independence and Efficiency
With our new microbiology lab, we are capable to perform in-house testing of our own generated Water for Injection (WFI) and Purified Water (AP). These water qualities are critical starting materials for the production of our GMP-compliant products, including buffers and process solutions commonly used along the production process of life saving drug products within the innovative biopharma sector.
As a side effect, we can also analyse samples from our regular cleanroom hygiene monitoring in-house, reducing reliance on external labs and significantly improving turnaround times.
Our Experts For you
Our Experts - Your Partners
Overview of key contacts - supported by many more specialists working for our partners and Clients behind the scenes.
Dr. Frank Velte
Head of CG Pharma & Biotech
+49 (0)511 87803-106
+49 (0)152 3466 7631
frank.velte@cg-chemikalien.de
Marco Regel
Head of Sales & Business Development
+49 (0)511 / 87803-146
+49(0)511 / 2516696
marco.regel@cg-chemikalien.de
Thomas Metzger
Sales & Business Development Manager
+49 (0)511 87803-258
+49 (0)79 483 72 81
thomas.metzger@cg-chemikalien.de
Verena Diederich
Head of Quality Management
+49 (0)511 87803-870
+49 (0)173 / 3857408
verena.diederich@cg-chemikalien.de
