SOP For Rinse and Swab Sampling from Equipment’s in Pharmaceutical Industries.
- SOP Covers below points:
- Sampling of Rinse sample for analysis
- Sampling of Swab sample for analysis
- Report format
1.0 OBJECTIVE :
- To describe the procedure for taking rinse / swab samples from equipment contact surface for getting checked in Quality Control department as preventive measure for contamination.
2.0 SCOPE :
- This procedure is applicable to rinse and swab sampling procedure carried out while taking rinse and swab from manufacturing equipment after cleaning.
3.0 RESPONSIBILITY :
- IPQA chemist
4.0 ACCOUNTABILITY:
- Quality Assurance Head
5.0 PROCEDURE :
5.1 Collect sample from product contact surface of equipment after cleaning of equipment is over as per SOP.
5.2 Get intimation from production department for sampling of Rinse water / Swab as per the Intimation.
5.3 Arrange supportive aids, i.e., test tube, beaker, sterile cotton swab, Aluminum foil, purified water from Quality Control department for sampling of rinse water / swab.
5.4 Collect rinse/swab for quantitative estimation of traces of API of product (processed before washing).
5.5 Prefer rinse water over swab. Take swab from area like compression, encapsulation machine.
5.6 Confirm that equipment and area is visually clean.
5.7 Sampling of Rinse sample for analysis:
- Ensure that the equipment is visually cleaned and is free from any residue.
- Collect approximately 10 ml of rinse sample for each active ingredient of previous product to be estimated , from the final rinsing of the contact part of equipment/ container / assembly in a beaker, transfer rinse in test tube and wrap the mouth using aluminum foil and label each test tube.
- Handover the sample to Quality control chemist or above along with Rinse / swab analysis intimation for testing.
- Quality Control Department will start the analysis after the receipt of the Rinse sample and allots a unique Quality Control Reference.
- Get the results from Quality Control Department and check. If satisfactory the processing of production can be started. Else, the respective equipment is to be re-cleaned/ washed / re-analysed.
- Attach the result of Swab / Rinse Analysis Intimation cum Report to respective product BMR/BPR.
5.8 Sampling of Swab sample for analysis:
- Swab stick need to be compatible with the ingredients of product, not interface with the assay, and comply the below specification.
- Sterile cotton swab Specification:
- Sterile cotton bud with polypropylene stick in screw capped polypropylene tube, size 75 mm x 12 mm diameter tubes, individually packed.
- Mode of Sterilization : ETO
- Stock of swab is maintained in Quality Control Department.
- Moisten the swab with the purified water and carry out the sampling using hand gloves, nose mask.
- Immediately after wetting the sterile cotton swab, swab the specific equipment surface.
- Take the swab of 10 cm x 10 cm.
- Take swab from the surface, apply the swab in a vertical motion or apply the swab in horizontal motion or in continuous strokes (Zigzag), as per geometry of the equipment or convenience.
- Note: Avoid lifting the swab stick at the contact surface during collection of the swab sample.
- Place the swab in sterile test tube containing purified water and wrap the mouth using aluminum foil.
- Handover the sample to Quality control chemist or above along with Rinse / swab analysis intimation for testing.
- Quality Control Department will start the analysis after the receipt of the swab sample and allots a unique Quality Control Reference.
- Get the results from Quality Control Department and check. If satisfactory the processing of production can be started. Else, the respective equipment is to be re-cleaned/ washed / re-analysed.
- Attach the result of Swab / Rinse Analysis Intimation cum Report to respective product BMR/BPR.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| Q.A. | Quality Assurance |
| Q.C. | Quality Control |
| BMR | Batch Manufacturing Record |
| BPR | Batch Packing Record |
| ml | Milliliter |
| cm | Centimeter |
| IPQA | In Process Quality Assurance |
7.0 ANNEXURES:
| Annexure No. | Title |
| 01 | Rinse / Swab Analysis Intimation cum Report |
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
ANNEXURES :
Annex. No. 01 Rinse / Swab Analysis Intimation cum Report
