In this post Standard Operating Procedure Fumigation in Production Area in Pharmaceuticals is describe.
1.0 OBJECTIVE:
To lay down the procedure for fumigation in production area.
2.0 SCOPE:
This procedure is applicable to disposal in production department.
3.0 RESPONSIBILITY:
Technical Associate : Operation
Officer/ Executive Production: Supervision
Head Production : SOP Compliance
4.0 DEFINITION(S):
NA
5.0 PROCEDURE:
5.1 Safety Precautions
5.1.1 Use proper safety apparel such as gowns, rubber hand gloves, nose mask and safety goggles during preparation and use of virosil solution.
5.1.2 Use freshly prepared solution.
5.2 Preparation of 20 % w/v Virosil solution
5.2.1 Take 200 ml of virosil and make-up to 1000 ml with Purified water.
5.3 Load 20 % prepared virosil solution in to the fogger.
5.4 Carry the virosil-loaded fogger to the area for fumigation.
5.5 Connect the fogger to the power plug.
5.6 Before switching ON fogger ensure that the AHU system in the desired area is OFF.
5.7 Switch ON the fogger for half an hour.
5.8 After half an hour carry out the fogger from area.
5.9 Intimate to utility to switch ON the AHU for approx. 5 minutes, then switch OFF the AHU. Leave the area as it is for 10-12 hours.
5.10 Write the status of area on status board as “Do not enter area under fumigation”.
5.11 After desired time period, start the AHU of same area to complete exhaust the virosil fumes.
5.12 Frequency: After any major civil works or as when required
5.13 Intimation to be given to utility department before fumigation of the specific area on Annexure-II
(Fumigation Intimation Record).
6.0 ABBREVIATION (S):
SOP: Standard Operating Procedure AHU: Air handling unit
7.0 REFERENCE(S):
NA
8.0 ANNEXURE(S):
Annexure – I: Details of Fumigation record Annexure – II: Fumigation Intimation record
9.0 DISTRIBUTION:
9.1 Master copy : Quality Assurance
9.2 Controlled copy( s) : Production department, Quality Assurance
9.3 Reference copy (s) : Production department, utility department
ANNEXURE I
Details of Fumigation record
ANNEXURE II
Fumigation Intimation record