SIA is the analysis services of gases quality in the point of use according to the standards defined in various pharmacopoeia monographs.
The objective of this service is to ensure the quality of gases used in the manufacture of APIs and pharmaceuticals.
Regular analysis, reliable production
Safety, documentation, and reliability. These are just some of the demands of today's pharmaceutical industry.
Analysis services from Linde Gas are specially developed for manufacturers of pharmaceuticals and active pharmaceutical ingredients (APIs) who use gas distribution systems in their production processes.
Meeting GMP requirements
Manufacturers of pharmaceuticals and APIs set very high procedures for safety and quality. This is also reflected in the standards set for gases and their distribution systems. To verify the contents of gas systems at factories operating under good manufacturing practice (GMP) requirements, a complete gas analysis should be carried out at least once a year. This is especially important where the gas comes into contact with the finished products.
Sampling is carried out by Linde’s qualified personnel in these proceedings, using special cylinder that has been designed for these type of samples.
In exceptional cases the customer, after prior training, are able to perform himself these sampling.
The gas sample can either be taken at the output of supply sources (liquid tanks or cylinder racks), as at a critical point of use in the production facility. Even where the whole gas system is qualified, Linde Gas can help with testing and analysis.
The gas sample is sent to one of our specialty gas laboratories for analysis. These laboratories can carry out several standardized analysis in accordance with the requirements of different pharmacopoeias (European, American…), as well as other special analysis that are subject to a pre-feasibility study.
Our analysis equipment is qualified to comply with the requirements of the pharmacopoeias.
The results are sent to the customer through a certified report of analysis and ensures total traceability.
A valuable resource, also for hospitals and pharmaceutical industry
Gases are used in most of the steps within the manufacture of APIs and pharmaceuticals, including research and development, production, and quality control. Our understanding of the production of pharmaceuticals and formulation technology makes us a resource to be used for every aspect of your gas needs. Analysis services from Linde Gas are also valuable to hospitals that have to adhere to the European pharmacopoeia.