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Standard Operating Procedure (SOP & Guideline) for swab test analysis. Swab 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.

Procedure for Swab Test Analysis

1.0   Objective :

• • To lay down the procedure for swab test analysis. Swab 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.

2.0   Scope :

• • This SOP is applicable in quality control and production for swab sampling and analysis.                               

3.0   Responsibility :

• • Production Chemist

• • Intimation to QA for swab Sampling

• • Filing of swab report in BMR/BPR

• • QA chemist

• • Swab sampling as per sampling plan

• • To send the sample along with intimation to QC

• • Receipt of swab report from QC and handover to production

• • Analyst / QC Chemist

• • Analysis of Sample and submission of report to QA.

4.0   Procedure for Swab Test (Sampling & Analysis):

• • After cleaning of machine / equipment Production Chemist shall handover duly filled and signed swab test intimation / analysis report to QA Chemist for swab sampling.

• • QA chemist shall visually the equipment for any stuck particles and do the sampling if visually clean.

• • If equipment is dirty or have any stuck particles then inform to Production Chemist for corrective action.

• • After physical examination QA chemist shall swab the 10x10cm² surface as per sampling plan defined in annexure III.

• • Knit polyester swabs shall be used for sampling.

• • Before sampling, wet the swab using purified water and squeeze the excess water by pressing on side wall of tube.

• • QA chemist shall swab the surface of equipment for 100 cm² area firmly and swab horizontally with one side of the swab and vertically with other side of the swab (10 strokes on each side or as feasible as per swabbing size).

• • Do not rub the surface in to & for motion.

• • Refer the typical diagram (Fig. 1 & Fig.2) given below to collect swab sample.

• • Put the swab into a clean tube, label the test tube for identification and transfer to the quality control laboratory for analysis.

• • Use the SS wire or SS rod if the sample location is so far and away to reach

• • QC Chemist shall enter the swab sample details in Swab Test Inward Register as per Annexure-I.

• • Product matrix shall be prepared as per Annexure-II.

• • Sonicate the swab sample in 10ml extract solvent defined in “Product matrix” for 5 minutes and analyze the swab sample as per procedure defined in “Product matrix”.

• • Measure the absorbance at particular wavelength defined in “Product matrix” and records the absorbance / results of swab sample solution on test data sheet.

• • Compare the swab sample absorbance/result with respect to standard absorbance (10 ppm) defined “Product matrix”.

• • If the swab sample absorbance/result within acceptance criteria as defined in “Product matrix”. Swab sample passes the test.

• • Record the analysis result on the “Swab Test Intimation Slip / Analysis Report” as less than 10 ppm and handover to QA after signature of QC Manager/Designee.

• • If the swab sample absorbance/result is not within acceptance criteria defined in Annexure-II then swab sample result shall be handled as per SOP for Handling of out of Specification results) to find out the laboratory error. If laboratory error does not find out then inform to QA and production department for further action.

• • After receipt of report QA shall review the QC comments and shall handed over to Production Chemist for filing in BMR/ BPR.

• • Swab Sampling Criteria:

• • Swab sampling shall be done on every 10^th batch or earlier batch in case of campaign manufacturing and tracking shall be maintained by production chemist through process area log and shall be updated under remark column.

• • Qualification of swab sampler / visual inspector for line clearance:

• • All QA personnel shall be qualified for swab sampling & visual inspection and production Chemist for visual inception.

• • Manager / designee of QA / Production department shall send the duly filled Annexure IV to Head QC / designee for qualification of on swab sampler / visual inspector.

• • Head QC Designee / shall spike the 3 plates SS plates (10x10cm) with 10 ppm Active Pharmaceutical Ingredient (Ondansetron / Sildenafil Citrate) for swab sampling and analysis.

• • Similarly another 3 plates shall be prepared in the same manner spiked with three plates of 5 ppm, 10 ppm and 15 ppm drug each for visual inspection.

• • After completion of activity, swab sampling shall be done from first three plates for QC analysis and visually inspect the later three SS spiked plates and write the observation in Annexure IV.

• • Trained QC chemist shall analyse the sample as validated method and report the results.

• • Head QC / designee shall review the results and sign with comments.

• • Finally Head QA shall review the data and Head QC comments and sign with approval / rejection comments.

• • All the analytical data shall be enclosed with report and shall be filed in the training file of the employee.

5.0   Annexure – Swab Test Analysis :

Annexure-I :  Swab Test Inward Register

Annexure-II :  Product matrix

Revision No.:…………………                                               Effective Date:………………………………..

Annexure-III :  List of equipments with sampling location

Annexure-IV :  Qualification of Swab Sampler / Visual Inspectors  

• Recovery Of Swab Sample:

• Spiking Study for Visual Inspectors for line clearance: