SOP on Cleaning of Pre-Filters of LAF Unit, Sterile Garment Cubicle, Dynamic Pass Box

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1.0 Objective:

To lay down a procedure for cleaning of the pre-filters of LAF Unit, garment cubicle, dynamic pass box.

2.0 Scope

This SOP is applicable for cleaning of pre-filters of LAF Unit, garment cubicle, dynamic pass box.

3.0 Responsibility

Production Officers / Executive.

4.0 Accountability

Production Head shall be accountable for the compliance of SOP.

5.0 Abbreviations

SOP : Standard Operating Procedure.

WFI : Water for Injection

LAF : Laminar Air Flow

6.0 Procedure :

6.1 Cleaning of LAF Pre filter:

6.1.1 Cleaning of the LAF pre filters is to be done on monthly frequency or whenever the differential pressure reading on the megnehelic gauge is found outside the specified limits.

6.1.2 Switch off the LAF unit from the main switch after the completion of days activities.

6.1.3 Safely remove the pre-filter unit’s alongwith frames from the laminar air flow unit.

6.1.4 Transfer the pre-filters to the equipment washing area in a polybag.

6.1.5 Clean the pre-filters using compressed air.

6.1.6 Wash the pre-filters with purified water.

6.1.8 Dry the pre-filters using compressed air in wash equipment area.

6.1.9 Clean the frame of the pre-filter with lint free duster soaked in WFI.

6.1.10 Dry the frame with a lint free duster.

6.1.11 Assemble the pre-filter into the frame and transfer to the respective areas in a polybag.

6.1.12 Fix the pre-filter assembly to the LAF.

6.1.13 Switch on the LAF and ensure the differential pressure is within the limits.

6.1.14 Record the cleaning details in format (specimen attached in Annexure-1) and get it checked by concerned Officer/supervisor.

Above cleaning procedure is applicable for the pre-filters of LAF Unit listed below

Sr no LAF description No of prefilters
01 Sterilization tunnel LAF preheating zone 01
02 Vial washing LAF 02
03 Garment washing LAF 02
04 Wash equipment area LAF 03
05 Bung processor cum steam sterilizer LAF 06
06 Sampling room LAF 01
07 Vial sealing machine LAF 03

6.2 Cleaning of Dynamic Pass box and Garment cubicle Pre filter:

6.2.1 Switch off the Dynamic pass box/Garment cubicle from the main switch after the completion of days activities.

6.2.2 Safely remove the pre-filter unit’s from Dynamic pass box/Sterile Garment cubicle.

6.2.3 Transfer the pre-filters to the equipment washing area in a polybag.

6.2.4 Clean the pre-filters using compressed air.

6.2.5 Wash the pre-filters with purified water.

6.2.6 Dry the pre-filters using compressed air in wash equipment area.

6.2.7 Transfer the pre filter to the respective areas in a polybag.

6.2.8 Fix the pre-filter to the dynamic pass box/Garment cubicle.

6.2.9 Switch on the dynamic pass box/Garment cubicle and ensure the differential pressure is within the limits

6.2.10 Record the cleaning details in format (specimen attached in Annexure-1) and get it checked by concerned Officer/supervisor.

6.2.11 Above cleaning procedure is applicable to the pre filters of dynamic pass boxes and garment cubicle listed below:

Sr No Description Equipment ID No.
01 Dynamic Pass box (cooling room)
02 Dynamic Pass box ( filling room)
03 Dynamic Pass box (sealing room)
04 Dynamic Pass box (sampling room)
05 Garment cubicle

Frequency of pre-filter cleaning.

Once every month/if the pressure differential is outside the Specified limits.

  Annexure-1

Cleaning record of Pre filters

Date Prefilter location Pre-filter ID No.  Cleaned By Checked by Remarks

 Frequency: Monthly/product change over/Differential pressure is outside the limits

7.0 Distribution

Master copy –  Quality Assurance

Controlled copies- Quality Assurance, Production, Quality Control

8.0 History

Date Revision Number
Reason for Revision
00 New SOP

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