| Handling of Swab Sampling |
1.0 OBJECTIVE To lay down the procedure for swab sampling of equipment. 2.0 SCOPE This procedure is applicable for involved in sampling of swab sampling. 3.0 RESPONSIBILITY • Officer-Quality Assurance & Microbiologist • Executive-Quality Assurance & Concerned Department 4.0 ACCOUNTABILITY • Head Concerned Department • Head Quality / QA 5.0 PROCEDURE 5.1 Swab sampling shall be performed to detect the microbial bio-burden and chemical residues of the previous product active pharmaceutical ingredient (API), after cleaning of the equipment. 5.2 QA personnel µbiologists shall be responsible for swabbing of chemical analysis & microbiologist for microbiological analysis samples. 5.3 On receipt of intimation for swab sampling, from the concerned department, QA personnel & microbiologist shall prepare the sampling kit, which consist of the following accessories at least but not limited: • Swab • Test tube / container • Gloves • IPA • Solvent (required for soaking of swab) • SS stencil having 5 x 5 cm square cut • Aluminum foil 5.4 QA personnel & microbiologist shall put gloves and other safety cover properly as per requirement before swab sampling. 5.5 QA personnel & microbiologist shall ensure cleanliness of the equipment visually prior sampling. 5.6 Rinse Samples: Collect the final rinse sample of all the components of the machine and make a composite sample during routine verification and send to QC for analysis after labeling. 5.7 Swabbing shall be performed only, if equipment is found visually clean. In case if the visual cleanness is not found satisfactory then same shall be intimated to concerned department for further corrective action. 5.8 QA personnel & microbiologist shall perform the swab sampling after satisfactory results of visual inspection for microbiological & chemical analysis samples respectively. 5.9 Swab sampling shall be carried out as per specific location or swab area as mentioned in cleaning validation master plan or if any other reference. 5.10 Sampling for chemical analysis shall be performed after microbiological sampling. 5.11 Microbiological sampling shall be performed either by using 10 ml (0.9%) saline or sterile water in pre-sterilized test tube. 5.12 For chemical residue, soak the swab in solvent as specified in analytical method validation. Swab sampling for chemical analysis shall perform in horizontal direction first then rotate the swab and perform in vertical direction as shown in figure 1. 5.13 After collection of swab (i.e. for chemical analysis), it shall be placed in the test tubes and cover the test tube using aluminium foil. The test tube containing sampled swab shall be forwarded to QC for further analysis. 5.14 After completion of swab sampling clean the surface area with 70% IPA. 5.15 Quality control department shall perform the analysis as per testing procedure. |