In May 2021 a revision to USP<1788> Methods for Determination of Subvisible Particulate Matter was published, its aim is to aid in clarification and support of the information given in chapters <788> Particulate Matter in Injections, <789> Particulate Matter in Ophthalmic Solutions, and <787> Sub-visible Particulate Matter in Therapeutic Protein Injections.
The scope of this study was to evaluate the BioCaptĀ® Single-Use’s (BCSU’s) ability to recover microorganisms in stressed conditions after four hours of continuous air sampling at 28 LPM. The European Pharmacopoeia Growth Promotion Test performed on the BCSU after incubation shows a good recovery rate (ā„ 70%), comparable between the two impactors tested (stressed and unstressed). All three test results aligned with acceptance criteria, and visual inspection of the media post-sampling was satisfactory. This study supports the use of BCSU for four-hour sampling with no change to its monitoring capabilities.
Case study: Learn how an isolator manufacturer (AUSTAR) partnered with a local supplier (EMS) to provide and install Particle Measuring Systems (PMS) instruments to meet their customer contamination monitoring requirements.
Learn how AST uses PMS instruments for isolator contamination control.Ā
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