To lay down the procedure for HEPA filter change.
2.0 SCOPE
This SOP shall be applicable for the procedure for HEPA filter change in Microbiology Laboratory.
3.0 RESPONSIBILITY
3.1 Microbiologist and above shall be responsible for the preparation and execution of this SOP
3.2 QC & QA Head shall be responsible for the checking and approval of this SOP.
3.3 HOD shall be responsible for the authorization of this SOP.
4.0 ACCOUNTABILITY
Head QC
5.0 PROCEDURE
5.1 Air supply to the sterile area must be appropriately filtered to minimize the potential for contamination by visible & Non-viable particulate matter.
5.2 HEPA filters are installed to get class 100 area at the time of critical operation.
5.3 It is essential to check the integrity of all HEPA filters used to get the required quality of air supply.
5.4 The integrity is checked by scanning the filter surface by using a suitable particle counter or a ‘Cold DOP’ with an aerosol generator and a photometer is used.
5.5 Filters are changed on the basis of the following observations during integrity testing of all HEPA filters.
5.5.1 Air sampled at the filter surface exceeds 100 particles per cubic feet per minute or 0.003% penetration of DOP smoke.
5.5.2 Damage to the filter media is more than 5% of the total area. Less than 5% of the filter media may be repaired using RTV sealant.
5.5.3 Leak is observed at the seal or bond between the filter media & frame. The air changes calculated for the room are less than 20 per hour, replace filters.
5.5.4 A pressure differential greater than 2 inches water gauge indicates the filter is no longer effective.
5.5.5 Velocity of LAF filters shall be check at 1 foot above the work area. Find out average readings.
5.5.6 If velocity is less than 59 ft./minute for Vertical LAF & less than 88 ft./minute for Horizontal LAF, the filter shall be replaced.
5.5.7 Calibration:
Calibration of HEPA filter shall be done by the external party on an annual frequency.
6.0 REFERENCES
N.A
7.0 ANNEXURE
N.A
8.0 ABBREVIATIONS :
SOP: Standard Operating Procedure
QCD: Quality Control Department
Dept. : Department
QC: Quality Control
QA: Quality Assurance
QCD: Quality Control Department
No. : Number
N.A: Not Applicable
LAF: Laminar Air Flow
HEPA : High Efficient Particulate Air
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