The Value of an On-Going Monitoring Program
Keeping your cleanroom and laminar flow bench operating at optimum efficiency is essential. This means having an active On-Going Monitoring Program (OGMP) in place, either by internal personnel or by utilizing your Certification Agency on a more regular basis. There are many good reasons for this program to be implemented, the main one being, is that you do not want any surprises when your cleanroom or laminar flow bench certification comes due.
Rooms and Benches are certified either Semi-Annual or annually and it is usually assumed that everything is working fine in between these visits. In most cases, it is.
- Check Pre-Filters for all air handling systems on a weekly basis, either visibly or via the use of a calibrated pressure differential gage. Change these filters as applicable, not on a time use basis.
- Check and record daily, Room Pressures. (See ISO 14644-4:2001 page 14&15 for recommendations). This is the first line of defense in making sure all is in proper working order. If pressures are not as per design specification, this indicates an immediate problem, therefore doing this daily is paramount.
- Check and record daily, Room Temperature and Humidity Readings. A minute swing in these readings may negativity impact your product.
- Check and record daily, Non-Viable Particle Counts at work elevation in areas of concern. This will provide you with a trending pattern.
- Visibly check all wall, ceiling surfaces for any unsealed penetrations, seal with approved sealant.
- Check and record daily, All Laminar flow bench pressure differential gages to note filter hepa filter differential pressure. This will also indicate that all cabinet fans are in operation.
If there are no pressure differential gages in the Laminar Flow Bench, there should be readily accessible ports, to measure the hepa filter pressure differential.
With this program in place, in conjunction with good personnel disciplines and housekeeping protocol, you will be guaranteeing yourself that there will be no surprises at the last minute, thus keeping your room or bench operating at optimum efficiency.
Ralph Kraft – President R. Kraft, Inc. – www.cleanroomservices.com – Servicing Clean Environments Since 1977