Gas services under GMP

Eurofins BioPharma Product Testing provides GMP testing on compressed gases, as well as gas supply (e.g. tanks, cylinders, reservoirs) and facility gas line testing.

We follow a proven approach of testing the “purity” of the gas at the supply and testing “impurities” at points-of-use (POUs) or critical-control-points (CCPs). Additionally, we can support you with identifying risks and issuing all required deliverables (e.g. risk assessments, qualification programmes, and risk-based sampling programmes).

Gasses in contact with the product or critical surfaces must be checked for appropriate chemical, particulate and microbial properties. (6.18)

Eurofins support with both gasline monitoring:

• Chemical impurities
• Particle counts
• Air sampling

Gas testing used as raw materials:

• Ph.Eur. / USP / JP

The authorities require GMP testing for all gases in contact with a final pharmaceutical/drug product or a primary container, in order to demonstrate the product’s appropriate chemical, particulate and microbiological purity. These GMP requirements should be combined with user requirements, such as specific undesired contaminants testing. Additionally, pharmacopoeias contain dedicated chapters addressing the specific requirements for both purity and impurities.

Eurofins BioPharma Product Testing uses validated methods to ensure that sampling and analytical testing are performed according to cGMP. Validation is performed at no additional cost in the case of standard matrixes.

We have developed a complete one-stop-shop solution for testing gases under GMP, covering both qualification and/or routine monitoring.

Our experts’ experience across the biopharma and medical device industries provide Eurofins BioPharma Product Testing with a unique understanding of the authority’s requirements. Risk assessments are key for ensuring a LEAN set-up; with this in mind, customers are advised to contact us during the very early qualification stage.