Single Use in Pharmaceutical Manufacturing

Single Use in Pharmaceutical Manufacturing

Continuous Microbial Monitoring Solutions

In order to ensure the full manufacturing process is continuously and reliably monitored, single use technologies are emerging as a vital tool for pharmaceutical manufacturing and are covered in the latest draft of the  EU GMP Annex 1. Single Use microbial monitoring solutions, validated for long-term, up to 4-hour sampling in critical environments at 25 LPM capture the entire manufacturing process, not just a quick snapshot of the cleanroom manufacturing environment:

active air sampler for Annex 1In an 8-hour process model there are four sampling units for continuous viable air sampling. This limits the need to frequently interfere with the pharmaceutical manufacturing process. With this approach, manufacturers can move away from snapshot-type sampling to nearly continuous monitoring. The final result will be that single-use viable monitoring plates will eventually replace settle plates completely.

In order to develop an individualized contamination control monitoring solution that considers single use for pharmaceutical manufacturing, consider the following and identify what best suits your process:

  • Continuous vs. infrequent sampling
  • Real-time vs. traditional viable cleanroom monitoring
  • Remote sampling vs. handheld devices and active air samplers
  • Cleanroom classification vs. monitoring
  • Flexibility vs. single-instrument

Get more details on single-use continuous monitoring solutions

Single use Solution for microbial monitoring in Pharmaceutical Manufacturing

See the Particle Measuring Systems BioCapt® Single-Use impactor page for more details on how a continuous monitoring approach can be achieved in pharmaceutical manufacturing.

Use the BioCapt Single Use impactor as part of a Cleanroom facility monitoring system, connected with an active air sampler such as the MiniCapt Mobile, or with our systems / instruments.

For validation support, contact Particle Measuring Systems’ Contamination Control Advisory Group.

For more information on changes to regulations, including EU GMP Annex 1 Single Use Requirements,  regarding microbiological monitoring of cleanrooms, download the full paper.

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