Posted on: 25th May 2018
The Stopper Quality team has identified a new methodology by which biopharmaceutical companies can measure levels of particulate contamination on elastomeric stoppers in a way which is sufficiently sensitive to meet current and future industry standards.
A survey conducted by the workstream found inconsistencies across member companies in how they measure particulate contamination. The methods used by companies were based on standards set over 13 years ago and were no longer sensitive enough for current or future levels.
Instead the updated method creates consistency across the industry which will allow companies to analyze data, reduce the amount of testing required, and lead to innovation within the manufacturing of new stoppers. Ultimately, a reduction in testing alongside an increased quality assurance will mean financial savings for companies working to these standards.
You can read about the progress that the workstream is making in BioProcess Online through the links below: