REMEDIES FOR HIGH MICROBIAL COUNTS

ST — 102
REMEDIES FOR HIGH MICROBIAL COUNTS


INTRODUCTION

It is an alarming situation to observe any microbial counts on the laminar because it is the critical area of product exposure. Hence immediate action is required when any counts are observed.

Also counts in other areas of the sterile room should be as possible to prevent any chance contamination of product. In case high microbial counts are observed, the following remedial action may be taken.

ON LAF

1. Confirm plates are taken into filling room only after they are kept under UV in the pass-through for 30 minutes.
2. Inspect each plate before exposure.
3. Plate exposure operator dose not cover plate during exposure.
4. Periodically spray benches with 70% IPA (Sterile). Sanitize LAF benches preferably before and after breaks.
5. Check for any leakages between bench and HEPA grill by smoke test.
6. Thoroughly sanitize the bench with 0.5% Aarshol after the day’s work.
7. If very high counts are observed, check the integrity of HEPA filters.

ROOM

1. Confirm the points 1 to 3 listed above.
2. Minimize the operators’ movements.
3. Thoroughly sanitize the required around the plate exposure location.
4. Clean the area periodically with sterile 70% IPA throughout the day.
5. Daily high counts will need area fumigation and change of disinfection agent.