1.0 OBJECTIVE
To lay down the procedure for collection of swab samples from surfaces of equipment and floor.2.0 SCOPE
This SOP shall be applicable to all the operational areas which are in direct contact with the product.
5.1.2 Transfer this swab into a graduated, stoppered test tube, containing 5 ml of distilled water.
5.1.3 Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.
5.1.4 Take the sterilized swab to the sampling area.
5.1.5 Take out the swab from the test tube and swab the surface of the equipment/floor, covering an area of 10 x 10 sq. cms, in unidirectional movements and not to and fro movements.
5.1.6 After swabbing, place the swab in another sterile test tube containing 10 ml of sterile buffered peptone water.
5.1.7 Shake the tube gently and let it stand for 15 minutes.
5.1.8 Remove the swab from the test tube and analyze the peptone water as per the specifications.
5.2.2 Transfer this swab into a clean, graduated stopper test tube, containing 5 ml of distilled water.
5.2.3 Take the swab to the sampling area.
5.2.4 Take out the swab from the test tube and swab the surface of the equipment, covering an area of 10 x 10 sq. cms, in unidirectional movements and not to and fro movements.
5.2.5 After swabbing, place the swab in another test tube containing 10 ml Acetate Buffer pH 4.0.
5.2.6 Sonicate the contents of the tube for 15 minutes
5.2.7 Transfer the contents to a 100 ml volumetric flask and make up the volume to 100 ml with Acetate Buffer pH 4.0.
5.2.8 Analyze this solution as per the specifications.
6.2 QA: Quality assurance
6.3 QC: Quality control
3.0 RESPONSIBILITY
Microbiologist4.0 ACCOUNTABILITY
Sr. Manager Quality Assurance5.0 PROCEDURE
5.1 Collection of swab sample for microbiological analysis
5.1.1 Take about 2 gms of absorbent cotton and wrap it around one edge of a glass rod.5.1.2 Transfer this swab into a graduated, stoppered test tube, containing 5 ml of distilled water.
5.1.3 Sterilize by autoclaving at 15 lbs pressure (121°C) for 15 minutes.
5.1.4 Take the sterilized swab to the sampling area.
5.1.5 Take out the swab from the test tube and swab the surface of the equipment/floor, covering an area of 10 x 10 sq. cms, in unidirectional movements and not to and fro movements.
5.1.6 After swabbing, place the swab in another sterile test tube containing 10 ml of sterile buffered peptone water.
5.1.7 Shake the tube gently and let it stand for 15 minutes.
5.1.8 Remove the swab from the test tube and analyze the peptone water as per the specifications.
5.2 Collection of swab sample for chemical analysis
5.2.1 Take about 2 gms of absorbent cotton and wrap it around one edge of a glass rod.5.2.2 Transfer this swab into a clean, graduated stopper test tube, containing 5 ml of distilled water.
5.2.3 Take the swab to the sampling area.
5.2.4 Take out the swab from the test tube and swab the surface of the equipment, covering an area of 10 x 10 sq. cms, in unidirectional movements and not to and fro movements.
5.2.5 After swabbing, place the swab in another test tube containing 10 ml Acetate Buffer pH 4.0.
5.2.6 Sonicate the contents of the tube for 15 minutes
5.2.7 Transfer the contents to a 100 ml volumetric flask and make up the volume to 100 ml with Acetate Buffer pH 4.0.
5.2.8 Analyze this solution as per the specifications.
6.0 ABBREVIATIONS
6.1 SOP: Standard operating procedure6.2 QA: Quality assurance
6.3 QC: Quality control
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Is it necessary to take swab samples for compression machine when parts are fully assembled? or can we take swab sample when parts are wash and dissemble..
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