1. OBJECTIVE
To provide a proper procedure for fumigation in production areas
2. SCOPE
It is applicable in all areas of production
3. RESPONSIBILITY
• Operator
• Production Pharmacist
• Quality Assurance officer
4. SAFETY INSTRUCTIONS
• Always use nose cover and goggles while doing fumigation.
5. PROCEDURE
5.1 Fumigation should be carried out at the end of production operation twice in the month and whenever required.
5.2 Production person shall ensure that raw material, finish good, intermediate or in process goods should not be present in the area of fumigation, if present cover all material with polythene bags.
5.3 Always use nose cover and goggles while doing fumigation.
5.4 Windows, doors should be closed, AHU’s should be switch off before starting fumigation.
5.5 Place 25% formaldehyde in plate on hot plate waits until fumes start. Switch off the hot plate.
5.6 Or add 1 gm KMnO4 in 100ml or formaldehyde taken in plate, wait until fumes start
5.7 Affix the label as Area under Fumigation Do Not Enter.
5.8 Allow the fumigation fumes to stay 6 to 7 hours.
5.9 After the specified time is over, enter the area only by stating the exhaust for 30 minutes.
5.10 Conduct cleaning before starting production.
5.11 After 30 minutes allow the AHU’s to stabilize the required temperature and humidity.
5.12 Then start the routine production.
5.13 Fill the fumigation record
6. RELATED DOCUMENTS
Fumigation record format – Annex-I
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
| Production Department | 01 | , |
8. ABBREVIATIONS
AHU’s Air Handling Unit
KMnO4 Potassium Permanganate
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 06/04/2023 | 00 N/A | First Version |