To establish a procedure for swab sampling for validation of test surface to evaluate cleaning efficacy.
This SOP is applicable to all the test surface validations for evaluating the efficiency of the cleaning procedures.
Microbiologist - Quality Control
Manager - Quality Control
5.1 For Chemical Evaluation
Material and Reagents
SWAB : A cleanroom laundered polyurethane foam swab
TRANSPORT : Molded into a polypropylene stick.
CONTAINER : Stoppered test tubes made of glass.
SAMPLING : As mentioned in the validation protocol.
SOLVENT : Method used for analysis of swab samples of respective active ingredients.
5.2 Swab sampling procedure
5.2.1 Pipette out 5 ml of sampling solvent in transport container.
5.2.2 Remove a swab from its protective bag using a clean latex hand glove.
5.2.3 Avoid touching the swab head to prevent its contamination.
5.2.4 Transfer the swab in transport container (test tube) containing 5 ml of sampling solvent and allow the swab to soak completely.
5.2.5 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 solvent drips inside the test tube.
5.2.6 Hold the stem of swab without touching the head of the swab.
5.2.7 Using one side of moistened swab wipe the test surface of 5 sq. inch with 10 firm horizontal strokes as illustrated in (Annexure I) using a clean template.
5.2.8 At the end of each stroke, lift the swab carefully.
5.2.9 Turn the swab over to its other side; wipe the test surface of 5 sq. inch with 10 firm vertical strokes as illustrated in (Annexure I) using the template.
5.2.10 At the end of each stroke, lift the swab carefully.
5.2.11 Hold the stem of the swab without touching the head of the swab and let the swab drop into the transport container. Plug the transport container with stopper and send for analysis after adequately labeling the same.
5.3 Procedure for microbiological evaluation
5.3.1 Take a sterile swab to sampling point.
5.3.2 Mark the swab with (1) Sampling point & (2) Date on outer cover.
5.3.3 Put on the clean latex hand gloves and disinfect the same with 70% IPA.
5.3.4 Take out the sterile swab carefully from the outer cover dip the swab in sterile water and swab the complete selected area (10x10 cm).
5.3.5 Replace the swab immediately inside the cover, close it and send for analysis. Sample should not be hold for a long period exceeding 24 hours
6.1 SOP - Standard Operating Procedure
ANNEXURE – I
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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