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Electronic Data in Pharmaceutical Manufacturing: Real-Time Microbial Monitoring (Series Part 6 of 6)

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Real-time (Active Air) Microbial Monitoring Benefits

Microbial Monitoring

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.

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)

Click here to contact our experts for questions.

Looking for a 21CFR Part 11 Solution for your cleanroom data. Look no further than PharmaIntegrity:

PharmaIntegrity Data Management System for Pharmaceutical Industry Data Integrity (21CFR11)

Relevant 21CFR Part 11 Data Integrity Materials

https://www.pmeasuring.com/blog/data-trending-annex-1-alert-levels/

https://www.pmeasuring.com/blog/new-normal-data-integrity-esignatures/

https://www.pmeasuring.com/blog/remote-audits-new-normal-21cfr11/

https://www.pmeasuring.com/blog/new-normal-particle-counter-data-remote-access-electronic-signatures/

https://www.pmeasuring.com/blog/electronic-data-in-pharmaceutical-manufacturing-microbial-monitoring/

https://www.pmeasuring.com/blog/data-integrity/

21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions

Tackling the 21CFR11 Challenge: From Paper to Paperless

Complete Cleanroom Contamination Control Solutions

Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.