Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 Frequently Asked Questions
Knowledge Category: Microbial
Contamination Control Strategy (CCS) 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.
Single Use Device Media Dehydration and Biological Recovery Efficiency
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.
Cleanroom Design Questions & Answers
This FAQ paper is a follow up to the webinar, “3rd Annual Cleanroom Design and Engineering Forum” presented by Anna Campanella. Many thoughtful questions were asked about non-viable particle counting requirements in cleanrooms and sampling placement pertaining to process design. Questions submitted during and after the webinar are answered by Anna Campanella, below. If you have any additional queries for our experts, submit them directly here.
