QUANTITATION OF NON-VIABLE AIR BORN PARTICULATES IN STERILE-AREA

1. PURPOSE

1.1 This procedure is established to describe the system for satisfactory work of HEPA filter.

2. SCOPE
2.1 It is applicable in the sterile areas.
3. RESPONSIBILITY
3.1 Quality Control manager
3.2 Microbiologist/Quality Control Officer
3.3 Micro-Lab attendant
4. PROCEDURE

4.1 Wipe clean the outside surface of the particle counter and other accessories required for monitoring and keep them in the UV pass box for 30 minutes for irradiation before taking them inside the sterile room for monitoring. While monitoring the HEPA filter in the component preparation area just wipe clean the particle counter and take it in room.
4.2 Keep All The Laminar Flows “On” in the room and using the MetOne particle counter at an air flow rate of 1 cubic ft. Per minute. Slowly scan each and every HEPA filter by passing the probe slowly across the filter surface at a distance of approximately six inches and working in a gird Pattern until the entire surface has been scanned with the instrument adjusted to detect particles of size 0.5 micron.
4.3 For each HEPA filter using the probe, scan the seal of each filter element to its frame and the seal between the filter frame and the filter housing to verify that particulates are not escaping around the filter.
4.4 Make a diagram of the filter surface and indicate the location of any point where there is a sudden increase in particle count.
4.5 Record all the particle count readings and compare them with the acceptance limits.

4.6 Also determine the particle count in clean room at different locations and compare it with Acceptance limits.

5. Interpretation of results

The displays shows the results of particles in Cubic Ft/ M which should be required to convert into Cubic meter, So
1 Cubic meter / M = Display in Cubic Ft/M x 35.31
= Particles in Cubic meter / M