Injectable products : Eurofins BPT France is at the forefront of packaging testing
Emmanuelle Ory, Testing Business Unit Manager, Eurofins BioPharma Product Testing France, Les Ulis, emmanuelleory@eurofins.com
Regulatory changes in the European Pharmacopeia in 2019 have been very challenging for most laboratories. New specifications for autoclave cycles led to significant decrease in the number of compliant cycles. A solution needed to be found quickly to ensure customer satisfaction and product safety. With years of experience, Eurofins BioPharma Product Testing (BPT) quickly responded and achieved qualification of all autoclaves and now delivers 100% compliant cycles for:
- Rubber closure according to Eur. Ph. 3.2.9 and USP NF <381>
- Glass, from a nominal volume of 1mL to 500mL according to Eur. Ph. 3.2.1 and USP NF <660>
- Designed qualified cycles for specific volumes
At the same time, Eurofins BPT France increased its capacity with the acquisition of new autoclaves, and dedicated a team of analysts to this specific activity.
Eurofins BPT France is now able to deliver analytical results for more than 100 batches weekly – not only for large and medium size biopharma companies which already trust Eurofins for many years, but also for new clients. Analysis of heavy metals on glass containers by AAS, ICP-OES, ICP-AES or ICP-MS is also part of Eurofins’ expertise, and its scientists are working closely with regulatory agencies on the topic of elemental impurities testing.
Eurofins BPT France can support every client involved in injectable solutions production. With almost 10 years of experience in packaging quality control testing, a scope of advanced equipment, including qualified autoclaves needed to simulate use in production conditions, the laboratory performs full testing of glass and rubber closures in accordance with GMP and European and American Pharmacopeias.
For more information, visit: www.eurofins.com/bpt