GMP testing for gases
Eurofins Biopharma Product Testing Denmark A/S (Eurofins BPT) provides full GMP-testing on compressed gases.
Eurofins BPT can test gas-supply (e.g. tanks, cylinders, reservoirs) and facility gas-line. The typical approach is testing the “purity” of the gas at the supply and “impurities” at points-of-use (POUs) or critical-control-points (CCPs). Additionally, Eurofins BPT can provide support for the identification of risks by and issue all required deliverables (e.g. risk assessments, qualification programs, risk-based sampling programs).
Why Choose Eurofins BioPharma Product Testing Denmark A/S?
- Local support from Subject Matter Expert (SME)
- Free access to Eurofins BPTs expertise
- Validated methods (GMP) for std. matrixes
- On-site sampling by GMP qualified specialists
- One-stop-shop solution including deliverables
- Support during qualification and/or monitoring
Why test gases under GMP?
The authorities require GMP testing for all gases in contact with the final product (pharmaceutical/drug product) or primary-container. Scope of testing is to show an appropriate chemical, particulate and microbiological purity. These GMP requirements need to be combined to user requirements like specific undesired contaminants. Additionally, the Pharmacopoeias provide specific chapters addressing the specific requirements both purity and impurities. Eurofins BPT uses validated methods, ensuring sampling- and analytical testing are performed according to cGMP. Validation won’t add on additional costs as long the gases tested represent standard matrixes.
Eurofins BPT has developed a complete one-stop-shopping solution ensuring full compliance with testing of gases under GMP covering both qualification and/or routine monitoring. Eurofins BPT’s SMEs have experience across Biopharma and Medical Device industries ensuring Eurofins BPT a unique understanding of the authority requirements. Risk Assessment is key for ensuring a LEAN set-up, therefore clients are advised to contact Eurofins BPT as early in the process as possible.
The approach EBPT offers
Eurofins BPT offers two standardized strategies (GMP):
- Sampling and Analytical testing of gases at supply (sampling gas-reservoirs)
- Sampling and Analytical testing of gases at POUs/CPPs (sampling on-site)
Both strategies are in full compliance with Pharmacopoeias, in addition to viable / non-viable contamination which can be created along- and/or before the filtration system of the gas line.