sop for swab sampling for validation of clean surfaces

1.0 OBJECTIVE

To establish a procedure for swab sampling for validation of test surface to evaluate cleaning efficacy.

2.0 RESPONSIBILITY

Quality Control Supervisor

3.0 ACCOUNTABILITY

Quality Control Manager

4.0 PROCEDURE FOR CHEMICAL EVALUATION

4.1 SWAB : A clean room laundered polyurethane foam swab molded into a polypropylene stick.

TRANSPORT : Capped test tubes made of glass.
CONTAINER

SAMPLING : As mentioned in the validation protocol of analytical method used for SOLVENT analysis of swab samples of respective active ingredients.

4.2 Swab sampling procedure

4.2.1 Pipette out 10 ml of sampling solvent in transport container.

4.2.2 Remove a swab from its protective bag using a clean latex hand glove.

4.2.3 A void touching the swab head to prevent its contamination.

4.2.4 Transfer the swab in transport container (test tube)containing 10 ml of sampling

solvent and allow the swab to soak completely.

4.2.5 Take out the swab from sampling solvent and squeeze the tip against inner

surface of test tube to remove excess solvent in such a manner that excess sampling

solvent drips inside the test tube.

4.2.6 Hold the stem of swab without touching the head of the swab.

4.2.7 Using one side of moistened swab wipe the test surface of 2” x 2” with 10 firm

horizontal strokes as illustrated in Fig. 1.

4.2.8 At the end of each stroke, lift the swab carefully.

4.2.9 Turn the swab over to its other side, wipe the test surface of 2” x 2” with 10 firm vertical strokes as illustrated in figure no.2.

4.2.10 At the end of each stroke, lift the swab carefully.

4.2.11 Hold the steam of the swab without touching the head of the swab and let the swab drop into the transport container. Cap the transport container and send for analysis after labeling the same.

5.0 PROCEDURE FOR MICROBIOLOGICAL EVALUATION

5.1 Take a sterile to sampling point.

5.2 Make the swab with (1) sampling point and (2) Date on outer cover.

5.3 Put on the clean latex hand gloves and disinfect the same with 70% IPA.

5.4 Take out the sterile swab carefully from the outer cover and swab the complete selected area (10 x 10 cm).

5.5 Replace the swab immediately inside the cover, close if and send for analysis.

6.0 ABBREVIATIONS

IPA = Iso Propyl Alcohol

7.0 REFERENCES
Nil

process validation protocol for methylcobalamin niacinamide and pyridoxine injection

validation protocol of sterility test

sop for Analytical Method Transfer

Protocol for hold time study of sterile garments