How Particle Measuring Systems Support Pharmaceutical Cleanroom Monitoring
After deciding on a cleanroom Facility Monitoring System (FMS) it is time to implement it. Many things can go wrong. You want an implementation that does not negatively impact production, that is smooth and successful, and is ready to hand off on schedule. Eric Gottlieb talks to Blu Buquoy about some of the possible roadblocks and how the team Particle Measuring Systems (PMS) prepares for a successful FMS implementation.
What is a Facility Monitoring System (FMS)?
A cleanroom environmental monitoring system (FMS) is generally a collection of remote particle counters, active air samplers, maybe some environmental sensors (TRH, DAP, etc. ) that are all connected together as a system to monitor filling lines, cleanrooms, biosafety cabinets, etc.
How does PMS Implement a System Without Affecting Customer Production?
Ideally, an FMS implementation happens during building construction, prior to production. A second time to target is during shut down, which is what normally happens during an upgrade. However, shut downs only happen for 2-3 weeks and our customers need to do other things at this time as well. To be successful, we plan the event carefully and get as much done as possible before the shut down occurs. For example, we can:
- prepare the documentation and have it approved ahead of the FMS implementation
- run the wires and tubing from the technical areas, outside the clean areas (ready to be inserted at shut down)
- get as much of the cleanroom FMS system commissioned as possible outside the clean area
- try to mimic the complete system and test it outside the clean area
The goal is to have everything ready so that as soon as the shut down occurs, we are ready to go.
What are the Risks of Doing an FMS Implementation During Shutdown?
The biggest risk to a successful FMS implementation during shut down is that something goes wrong and more time is required. Often this is caused because there are other functions going on during the shutdown that can affect the system. To prepare for this, we highly recommend a Risk Assessment (RA) to identify what could go wrong and how to plan for it.
We plan with all groups that might be involved or affect the event and coordinate efforts with all involved.
Only Particle Measuring Systems (PMS) offers complete contamination control solutions for our customers including:
- Viable and non viable particle counters
- Remote and portable sensors
- Project implementation
- Advisory services including Risk Assessments, Sample Placement, QRM…
- Data Management
Learn more about Planning and Installing a Facility Monitoring System (FMS)
Case study example of how PMS supported FMS installation even remotely, during COVID