CONTROL AND PLACEMENT PLANS OF BIOLOGICL MONITORS

ST — 043
CONTROL AND PLACEMENT PLANS OF BIOLOGICL MONITORS


INTRODUCTION

Monitoring and controlling of vial micro-organism is as important as the controlling of non-viable particulate matter which often transport viable micro-organism, because there are chances that these viable micro-organism may find their way into the product and contaminate the product.

The most common method of monitoring the air in the sterile area is by the use of settling plates containing soybean casein digest agar.

1. Soybean casein digest agar medium is used to identify the presence of microbial organisms in containing soybean digest agar.
2. Petridishes containing soybean casein digest agar medium suitably prepared and provided by QC are marked with numbers that correspond to the locations where plates are to be exposed.
3. Plates should be exposed at work height, on tabletops or carts positioned to collect representative sample.
4. Sterile room must be monitored whether or not there is activity on every working day.
5. Plates should be exposed during each shift working.
6. One plate should be exposed upto 100 sq. ft of floor area and one additional plate for each additional 100 sq. ft of floor area.
7. Expose one plate at the location of highest particle count determined by long count.
8. All LAF hoods must be monitored in unmanned state.
9. One plate is kept as negative control; on this plate the time at which plates are to be exposed is marked.
10. All the plates are kept in pass box under UV lamp in lid sown position half an before the exposure commences.
11. Plates are exposed for minimum 60 minutes during working hours and then kept back in the pass box to be taken for incubation.
12. Plates are incubated at 30 ºC to 35 ºC for 48 hours and then 20 ºC to 25 ºC for further 72 hours.
13. At the end of 48 hours, total number of colonies of bacteria and fungus are down in plate count of sterile area from by equality control microbiologist and second reading taken after 72 hours for fungus.
14. Area disinfection procedure is reviewed and attention is paid to the area where high counts are observed consistently.
15. 5% Copper Sulphate treatment or 2% Bacillocid treatment is carried out when fungus presence is observed in the area consistently for two-three days.

FREQUENCY - DAILY