contamination control strategy for a fill line cleanroom contamination sources
How to Build a Contamination Control Strategy: Considerations and Steps

Mass-produced pharmaceuticals have come far since the industrial manufacturing of synthetic drugs at the end of the 19th century with rapid advancement in technology, process control, and sterility requirements. Yet even as improvements to Pharma develop, recalls still occur with regularity and their significant impact on both the manufacturer and consumer are why worldwide regulation of the industry is so enforced. Environmental monitoring (EM) is one facet of the greater picture of current good manufacturing practices (cGMPs) that has been standardized for the safety of human health.

Media Dehydration and Biological Recovery Efficiency
Maximizing Microbiological Monitoring

The scope of this study was to verify the performance of collecting contamination from continuous three-hour samplings using the BioCapt® Single-Use manufactured by Particle Measuring Systems under unidirectional airflow, at 22 °C with 48% relative humidity. All four test results aligned with acceptance criteria, and visual inspection of the media post-sampling was satisfactory. With the backing of this study, BioCapt Single-Use can be used for three-hour sampling with no change to its monitoring capabilities.

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