SERVICING POLICY – CLEAN AIR SYSTEMS AND DEVICES MONITORING

ST — 106
SERVICING POLICY – CLEAN AIR SYSTEMS AND DEVICES MONITORING


The system includes:

1. HEPA Filters
2. Prefilters
3. Grils
4. Manometer/Manometer Oil
5. Light and electricals
6. Blower/Impeller
7. Motors
8. Plenum
9. Airflow velocity

Monitoring Include

1. Cleaning and checking of equipment in the systems routinely
2. Leak test/integrity test of HEPA filters
3. Maintaining records of observation and readings
4. Repairing/replacing/rectifying whenever necessary

Equipment in the System includes
1. 4 terminal HEPA filters in filling room (i.e. class 10,000 area)
2. 3 terminal HEPA filter in the three change rooms ( one terminal filter in each room)
3. 12 ft. horizontal LAF unit with 4 HEPA filters in sterile filling room
4. Gradvel down-flow laminar unit with two HEPA filters for ampoule filling in sterile filling room
5. Gradvel down-flow laminar unit for aseptic filtration in sterile filling room
6. Down-flow laminar above small right angle conveyor in filling room
7. Down-flow laminar above large turntable in filling room
8. Down-flow laminar above vial sealing machine
9. One LAF down-flow unit for rubber stopper washing in component preparation room
10. One LAF down-flow unit for component wrapping before sterilization in component preparation room
11. Gradvel down-flow laminar unit with two HEPA filters for vial/ampoule washing
12. HEPA filter module on the dry heat sterilizer
13. All prefilters of the LAF units
14. Booster fan connected to the air handling system
15. Prefilters in the booster system
16. All grill in the air handling system

Frequency of Monitoring

Clearing & checking – once in 3 months
HEPA Filter – DOP Test – once a year
Integrity Test of HEPA filter by DOP Aerosol challenge using ATI Model TDA 2E particulate detection apparatus or any other suitable instrument. Velocity: Velocity reading using Alnor Velometer 6000P series suitable or any suitable instrument.

FEQUENCY: QUARTERLY