Analysis Services - Pharmaceutical industry
Analysis services are aimed at manufacturers of finished pharmaceuticals and APIs that have gas systems in which the gas is used during manufacture.
To verify the contents of the gas system at factories operating under 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. For example, ICH Q7A §7.31 states that complete analysis shall be carried out at suitable intervals, and SLS (Swedish standard) 2003 – Contract deliveries – recommends that parallel analyses are to be done at suitable intervals (e.g. at least once per year).
The gas sample is sent to AGA’s specialty gas laboratory for analysis. AGA’s specialty gas laboratory can carry out both standardised analyses in accordance with the requirements of Ph Eur and USP, as well as completely unique gas analyses by arrangement. At AGA’s specialty gas laboratory the analysis equipment is qualified in comply with the requirements of the pharmacopoeias. AGA’s specialty gas laboratory is also SWEDAC accredited for analyses of gases used for smoke stack exhaust control. The results of the analysis are summarised in an analysis report.