SOP for Maintenance of Environmental Control

1.0 PURPOSE:

This document deals with the procedure for maintenance of Environmental Control.

2.0 SCOPE:

Applicable to Form Fill Seal department.

3.0 RESPONSIBILITY:

Form Fill Seal department staff.

4.0 ACCOUNTABILITY:

Head of Department

5.0 PROCEDURE:

5.1 Check all air handling systems of manufacturing and filling area are ‘ON’.
5.2 Record the air pressures of the sterile area in differential pressure checklist.
Limit
A) Filling Room FFS - 1.5 - 2.0 mmwc
B) Manufacturing Area - 1.5 - 2.0 mmwc
Frequency: Every Shift.
5.3 Ensure that area sanitization is carried out every shift as per SOP.
5.4 a ) Deposit all wastes in the waste bin containing a black poly-bag.
b) Keep waste-bins always closed.
5.5 Check fixtures, walls and floors for absences of any damage/crevices. (If required, recondition the same immediately through engineering department ).
5.6 Clean window glass, doors, S.S. switch panels with a wet duster, followed by a dry duster.
Frequency: Once in a day.
5.7 Record the temperature and humidity of filling and manufacturing area every shift in temperature and humidity checklist.
Temperature Limit: 22 ± 4°c Humidity: 50 ± 5 %
NOTE: If readings are beyond limits, report to the engineering department and take Appropriate action on AHU’s to get within limits.
5.8 Check the microbial count in filling and manufacturing areas as per microbiological method.
5.9 Swab testing of walls, floors to be done as per microbiological method.
5.10 Swab test of operator gloves and gowns to be done as per microbiological method.
5.1 Air sampling should be done at various points in the area as per microbiological method.
5.12 Carry out the fumigation as per SOP on the weekends.

6.0 ABBREVIATIONS:

Mmwc: Millimeter of water column
%: Percentage
° c: degree Celsius
Clean window glass, doors, S.S. switch panels with a wet duster, followed by a dry duster.
Frequency: Once in a day.

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