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 utilizing your Certification Agency on a more regular basis.
There are many good reasons for this program to be implemented, the main on being, is that you do not want any surprises when your cleanroom or bench certification comes due.
Rooms and benches are certfiied either Semi-Annual or Annually and it is usually assumed that everything is working fine between these visits. In most cases, it is.
To insure that, you should consider:
1. Check pre-filters on 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.
2. Check and record daily, Room Pressure (see ISO 14644-4:2001 pages 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.
3. Check and record daily, Room Temperature and Humidity readings. A minute swing in either of these readings may negatively impact your product.
4. Check and record daily, Non-Viable particle counts at work elevation in areas of concern. this will provide you with a trending pattern of your room for benchmarking.
5. It is every persons responsibility that enter the clenroom to visually check all wall, ceiling surfaces for any unsealed penetrations. These penetrations are to be seal with approved sealant by the proper personnel. Remember the cleanroom is a sealed vessel with registers that can be regulated to maintain room pressurization.
6. Check and record daily, all Laminar Flow bench pressure differential gages to note Hepa filter differential pressure. This will also indicate that all cabinet fans are in operation. If there is no pressure differential gage 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 cleanroom and or Laminar Flow bench operating at optimum efficiency.