SOP For Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility
1.0 Objective
1.1 To establish a procedure for performing viable particle monitoring of drain points in the Sterile Product Manufacturing Facility to ensure microbiological control and compliance with applicable regulatory requirements.
2.0 Scope
2.1 This SOP is applicable to viable particle monitoring of all designated drain points within the Sterile Product Manufacturing Facility.
3.0 Responsibility
3.1 Officer or above – Microbiology Laboratory:
- To perform sampling, testing, incubation, and documentation as per this SOP.
3.2 Head – Microbiology Section / Nominee:
- To ensure implementation and compliance with this SOP.
- To review and verify the monitoring results.
4.0 Accountability
4.1 Head – Quality Control / Nominee:
- To ensure overall compliance of microbiological monitoring activities.
4.2 Head – Quality Assurance:
- To ensure adherence to the approved procedure and regulatory requirements.
5.0 Procedure
5.1 General
5.1.1 Viable particle monitoring of drain points shall be performed by authorized microbiology personnel.
5.1.2 Monitoring shall be carried out using the surface swabbing method.
5.2 Preparation of Media and Accessories
5.2.1 Prepare and sterilize the required number of SCDA (Soybean Casein Digest Agar) plates as per the SOP on preparation of sterile media.
5.2.2 Pre-incubate prepared media as per the respective SOP before use.
5.2.3 Sterilize the required number of test tubes containing 10 mL sterile saline along with sterile swabs. Arrange them in a sterilized test tube stand.
5.2.4 Sterilize the required number of stainless steel (SS) carriers.
5.2.5 Place the test tube stands inside SS carriers.
5.2.6 Transfer the SS carriers to the manufacturing facility by following the approved plant entry procedure.
5.2.7 Remove the required items from the SS carrier inside the facility and initiate sampling as described below.
5.3 Sampling Method – Surface Swabbing
5.3.1 Aseptically open the test tube containing the sterile swab.
5.3.2 Partially withdraw the swab and gently press it against the inner wall of the tube to remove excess saline.
5.3.3 Completely remove the swab and swab approximately 25 cm² surface area of the designated drain point in the specified direction (refer Figure 1).
5.3.4 After sampling, immediately place the swab back into the tube containing saline and close securely.
5.3.5 Label each sample tube/plate with location code, shift, and date on the bottom side.
5.3.6 Follow the same procedure for all designated drain points.
5.3.7 After completion of sampling, place all swab tubes back into the test tube stand and keep them inside the SS carriers.
5.3.8 Transfer all sampled swab tubes to the Microbiology Laboratory for analysis.
5.4 Microbiological Analysis
5.4.1 Perform testing in the Microbial Limit Testing (MLT) room.
5.4.2 Vortex each tube containing the swab and saline to ensure proper mixing.
5.4.3 Filter the saline solution through a sterile 0.45 µm membrane filter.
5.4.4 Rinse the membrane filter three times using 100 mL of 0.1% sterile peptone water each time.
5.4.5 Place the membrane filter aseptically onto a pre-incubated SCDA plate.
5.4.6 Use a separate sterile filter holder for each sample to prevent cross-contamination.
5.5 Incubation and Observation
5.5.1 Incubate the plates at 20–25°C for 72 hours.
5.5.2 Subsequently incubate at 30–35°C for an additional 48 hours.
5.5.3 Observe plates after 72 hours and again after the additional 48 hours.
5.5.4 Record observations and results in the designated annexure.
5.6 Frequency
5.6.1 Viable particle monitoring of drain points shall be performed once every month.
5.7 Acceptance Criteria
5.7.1 Verify that the monitoring results are within the acceptable limits specified in the respective annexure.
5.7.2 Any results exceeding the specified limits shall be investigated as per the applicable OOS/Deviation handling procedure.
6.0 List of Annexures
- Annexure – 01: Report of Viable Particle Monitoring of Drain Point
SOP on Out of Specification (OOS) Results in Microbiology Laboratory