Planning and Installing a Facility Monitoring System
Strong planning, following GAMP guidelines, and proper training to understand how to interpret the system data are essential for an effective monitoring program. A successful implementation requires planning, implementation, testing, and training to understand the results.
For aseptic manufacture of pharmaceutical products there has been a shift in procedures for particle measurement, primarily due to legislative regulations. Traditionally, monitoring has been the classic portable monitoring of a cleanroom. New regulations have led to a requirement for an automated, remote monitoring solution. This paper reviews the various steps for the implementation of an automated monitoring solution for a non-viable particle counting system. The steps also apply if you later enhance the nonviable-particle counting system to include a viable-particle monitoring or other environmental parameter component.
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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.
