Reliability & quality
Our promise: Through consistent performance and high standards, we earn our customers' trust.
Our quality assurance is supported by our in-house chemical/physical laboratory, which tests raw materials and finished products according to pharmacopoeial specifications. Our microbiological laboratory 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.
In addition to our in-house testing capabilities, we also hold agreements with external GMP-qualified lab partners.
Our 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
Microbiological Lab
Ensuring continuous microbiological monitoring: The lab supports and ensures 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 products (PDMPs).
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 of performing 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 throughout 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.
