Standard Operating Procedure for the Swab Analysis.
- OBJECTIVE
- To lay down the procedure for the Swab Sample Analysis.
- SCOPE
- This procedure shall be applicable for Swab Sample Analysis in the microbiology department.
- RESPONSIBILITY
- Trained and qualified and approved microbiology personnel shall be responsible for swab analysis as per the established procedure.
- Officer or above shall be responsible for ensuring that the same is carried out correctly and checking documents for completeness of the content.
- The Head Microbiology/ Designee shall be responsible for compliance with the SOP.
- ACCOUNTABILITY
- Head- Microbiology/ Designee shall be accountable for the proper implementation of the SOP.
- DEFINITIONS
- Swab analysis is a microbiological test used to collect & analyze the surface samples for the presence of microorganisms.
- PROCEDURE
- The procedure of Swab Analysis Sampling:
- Take a pre-sterilized readymade cotton swab.
- Add 1.0 mL sterile normal saline/ 0.1% Peptone water into a swab tube for wetting the cotton bud.
- Bring the swab tubes at the sampling location.
- Aseptically open the swab tube containing with normal saline/ Peptone water solution. Take out the sterile swab partially, press the swab to the internal walls of the tubes gently to remove the excess saline/ peptone water, and take it out gently.
- Swab out 5 X 5 cm2 area in the direction specified in the figure below. Use a sterile stainless steel template to measure the area of sampling whenever applicable.
- The procedure of Swab Analysis Sampling:
- Place the swab back in the tube.
- After completion of sampling, label each swab with the sample name, date of sampling, and the initial sign of the microbiologist and bring the swab to the microbiology department.
- The procedure of Swab Analysis Sample:
- Transfer the swab samples to the micro lab-1 through the dynamic pass box between MLT passage to the Incubation room and the sample shall be transferred as per the respective SOP of Material Flow in the Microbiology Department.
- Sanitize hand with 0.2µ filtered 70% IPA.
- Arrange the sterile manifold unit and pre-incubated SCDA plates in laminar airflow.
- Make the attachments of the manifold unit to the suction pump and waste water reservoir.
- Fix the sterilized filtration cup/ funnel on the manifold unit and place the sterilize 0.45 µm membrane filters on the sterile filtration cup and funnel with the help of sterile forcep taking care that the forceps does not damage the filter and touch anywhere.
- Prewet the 0.45 μm membrane filter with approx 100 mL of 0.1 % peptone water. Open the knob of the manifold unit so that the rinsing fluid filters through the membrane.
- Shake the swab sample well and after completion of the filtration, transfer the content of the swab sample in the filtration cup and open the knob of the manifold unit so that the sample filters through the membrane.
- Transfer 3 X 100 mL of rinsing fluid (0.1 % peptone water) in the filtration cup. Filter the rinsing fluid with the help of a vacuum pump.
- Remove the filtration cup and transfer the 0.45 µm membrane filter on the surface of pre-ncubated SCDA media plates with the help of sterile forceps.
- Prepare one negative control plate by filtering 100 mL of sterile 0.1 % peptone water through the 0.45 µm membrane filters and put the 0.45 µm membrane filters on the surface of pre-incubated SCDA plate and incubate along with the test samples.
- Incubate the plates with the membrane in an inverted position at 22.5 ± 2.5 °C for 72 hours and 32.5 ± 2.5 °C for 48 hours.
- After the completion of the incubation period, withdraw the plate from the respective Incubator and observe the plate and record the result as per Annexure-I.
- ABBREVIATIONS
- °C : Degree centigrade
- DPB : Dynamic Pass Box
- μm : Micrometer
- mL : Mili Litre
- % : Percentage
- MB : Microbiology
- SOP : Standard Operating Procedure
- SCDA : Soyabean Casein Digest Agar
- % : Percentage
- µ : Micron
- REFERENCES
- Nil
- ANNEXURES
- Annexure-I: SOP/MBXX-FXX Report of Swab Sample Analysis
- DISTRIBUTION DETAILS
- SOP shall be distributed to the following departments.
- Quality Assurance.
- Microbiology Department.
- Production Department
- SOP shall be distributed to the following departments.
- REVISION HISTORY
| SOP Version No. | Change Control No. | Reason for revision | Effective Date |
| 00 | NA | First issue |
| REPORT OF ANALYSIS OF SWAB SAMPLE |
Sample Details :
| Name of Sample | |||
| Batch No. | Microbiology Ref. No. | ||
| Date of Sampling | Sample By | ||
| Date of Testing | Date of Completion | ||
| Incubation Details : | |||
| Incubator ID .……………. | From Date & Time………………………Sign/Date………………………….. To Date & Time…………………………..Sign/Date………………………….. | ||
| 22.2± 2.5°C | |||
| Incubator ID .……………. | From Date & Time………………………Sign/Date………………………….. To Date & Time…………………………..Sign/Date………………………….. | ||
| 32.2± 2.5°C | |||
Media Details :
| Name of Media | Media Lot No. | Prepared On | Use Before Date |
| SCDA | |||
| Normal Saline | |||
| 0.1 % peptone water |
Observations :
| Sampling Point Name/ ID | Observations | Acceptance Criteria | Remarks | |
| Total Bacterial Count | Total Fungal Count | |||
| Positive Control | ||||
| Negative Control | ||||
| Conclusion: The above samples tested for swab sample analysis complies/ does not comply the test as per the acceptance criteria. | ||||
Analyzed By: Reviewed By:
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