Real-time (Active Air) Microbial Monitoring Benefits

Microbial contamination can impact clean manufacturing in similar ways to particles. However, while non-viable particulate can be cleaned by filtration, even minor microbial contamination can replicate and spread. Monitoring the microbial contamination levels in your cleanroom provides a cost-effective way to understand the sterility of the area and it provides actionable data to implement corrective procedures.

How can you increase the confidence in your microbial monitoring program?

The most basic approach to cleanroom microbial monitoring is the use of portable instruments. These are moved throughout the facility to manually measure current contamination levels. This approach is easy to deploy and requires little capital investment, but carries more significant long-term labor costs. This is a sensible and compliant solution for small operations and cleanroom certifications.

Another fully-compliant approach is remote (active-air) microbial monitoring. This method employs a stationary instrument that continuously monitors and periodically reports environmental data to a central computer. This involves more upfront instrument cost, but saves the user limitless time in monitoring activities and greatly reduces the potential for operator error.

As with any system, the greater the quantity of samples taken, the better the confidence in the data. To increase the certainty that the area being monitored is under control, a continuous monitoring system with easily accessible data gives the user a clear long-term advantage.

 

Click here to learn more about an innovative and paperless approach

to Cleanroom Monitoring & Data Integrity: PharmaIntegrity

 

See links to additional supporting resources below: 

On-Demand Webinar: Replacing Settle Plates with Active Air Sampling

Application Note: Active Air Sampler Comparison Study in Remote Settings

Application Note: Recent Advances in Pharmaceutical Regulations for Viable Environmental Monitoring

Applicable Standards: 21 CFR 211 & cGMP, ISO 14644-2, EU GMP Annex 1, USP 797.

 

Want to read more? Jump to other released posts in this series:

Part 1 of 6: Data Integrity

Part 2 of 6: Paperless Reporting

Part 3 of 6: Secure Data Transfer

Part 4 of 6: Rapid Response to Deviation Events

Part 5 of 6: Reducing Operator Error

Part 6 of 6: Real-time Microbial Monitoring (You are here)

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