SAMPLING: SOP ON SWAB /RINSE SAMPLING CONFIDENT 1

PURPOSE: To lay down a procedure for sampling a swab or rinse sample from different equipment or areas.

SCOPE: This SOP applies to sampling rinse or swabs from different equipment/parts/areas at various stages of product processing.

REFERENCE: In-House

CROSS-REFERENCE DOCUMENTS

ATTACHMENTS:

S.No.	Attachment No.	Attachment Title
1.	Attachment-I	Rinse/Swab sample intimation cum analysis report.
2.	Attachment-II	Label for Rinse/Swab sample

DEFINITION:

Swabbing and rinsing are the two most common techniques used to sample cleaned surfaces (FDA, 1993). Swabbing is a direct surface sampling method, while rinsing is an indirect method. In practice, physical access to surfaces and parts of equipment to be cleaned tends to drive the choice of sampling method.
Swab test and rinse test analysis is being done to avoid chances of cross contamination from one product to another. By this method we assure that the machine / equipment is free from active ingredients of previous product.
RESPONSIBILITY:

2. Production Head:

3. Quality Assurance Head:

PROCEDURE:

SAFETY/PRECAUTION/EHS:

After cleaning of equipment as per the concern SOP, the user of the equipment shall give the duly filled sample intimation cum analysis report (Attachment-II) to QA person for sampling of rinse from given equipment’s/parts/area.
After receiving of this intimation form QA person shall properly check all entries for their correctness.
If all these found correct then QA person shall check visually to the equipment that are mentioned in intimation form.
If given equipment found visually clean then proceed for sampling otherwise inform to user for re-cleaning.
Rinse sampling procedure

For the sampling of the rinse sample QA person shall use a clean transparent PET/glass Bottle of 50 to 100 ml volume.
During final rinsing with a measured quantity of purified water QA person shall collect rinse water sample of about 50 ml in a cleaned PET/glass bottle for every equipment or part and also collect one blank sample.
Attach duly filled label as per Attachment-II to all bottles of each equipment/parts sampled and enter the sign, date & time of sampling in the sample intimation form.
Send all the labeled bottles to QC with Rinse/Swab sample intimation cum analysis report.

After cleaning of equipment/area as per concerned SOP, the user of the equipment/area shall give the duly filled Rinse/Swab sample intimation cum analysis report as per Attachment-I to the QA person for the sampling of swabs from the given equipment/part/area.
After receiving of this intimation form QA person shall properly check all entries for their correctness.
If given equipment/area found visually clean then proceed for sampling otherwise inform to user for re-cleaning.
For sampling of swab sample QA person shall use fresh non-sterile swab stick for
product residue/impurity analysis or sterile swab stick for microbial load analysis.

Note: For microbial load analysis, microbiologist shall perform sampling.

For product residue/impurity analysis QA person shall collect the sample with the help of swab stick in a measured area of 5 x 5 cm² using S.S. plate of 5 x 5 cm²
Moist the swab in purified water/solvent and squeeze with the help of test tube wall to remove excess water/solvent.
Now rub the swab stick applying a gentle force on stick and move in horizontal and vertical direction covering whole surface area of 5 x 5 cm² or as specified in the monograph shown below
After removing adhered residue from surface put the stick in test tube/tube and close the mouth of tube with aluminum foil or by other mean and collect one blank sample.
Attach duly filled label to all swab tubes of each equipment/parts/area sampled and enter the sign/date/time of sampling in the sample intimation cum analysis form.
Send all the labeled swab tubes to QC with sample intimation cum analysis form for analysis of the swab sample.

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