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.
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
Particle Counter Data and Cleanroom Solutions in the New Normal: Part 1
Electronic Data in Pharmaceutical Manufacturing: Real-Time Microbial Monitoring (Series Part 6 of 6)
Electronic Data in Pharmaceutical Manufacturing: Data Integrity (Series Part 1 of 6)
21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions
Complete Cleanroom Contamination Control Solutions
Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:
- Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial Monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
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.
