SOP ON DRAIN POINT MONITORING
PURPOSE: To provide a procedure for Drain Point Monitoring.
SCOPE: This procedure is applicable for Drain Point Monitoring in the microbiology Lab.
ATTACHMENTS :
Drain Point Monitoring Schedule (Template)
Drain Point Monitoring Record
Intimation For Results Exceed
Drain Point Monitoring Trend (Template)
Annual Trend Summary Report (Template)
RESPONSIBILITY:
Microbiologists Person shall be responsible for To follow this procedure during Drain Point Monitoring & maintaining the record.
Head QC/Designee shall be responsible for To review new or revised SOP and To maintain the controlled copies of SOPs at the required location
Head QA/Designee shall be responsible for To approve new or revised SOP and Ensuring implementation of the system as per the defined SOP
The plant Head shall be responsible for: Approving new or revised SOP and To ensure the implementation of the system as per the defined SOP
PROCEDURE:
SAFETY/PRECAUTION/EHS
Pre-incubated plates shall be used for drain point sample analysis.
Check the plates for any microbial contamination & physical integrity of Solid media.
Check the cleaning Status of the area where drain point monitoring has to be done.
Precautions to be taken during drain point monitoring.
Swabs should be sterilized.
Drain Point Monitoring should be done as per the prepared schedule.
Preparation of Plates & Other Accessories
Prepare the pre-incubated SCDA plates as per the urrent version of SOP.
Prepare the Buffered Sodium Chloride-Peptone Solution pH 7.0. Buffered Sodium Peptone water of the required quantity and sterilized it by autoclaving.
Transfer 10 ml above sterilized Buffered Sodium Peptone water in sterilized tubes.
Take these tubes and pre-sterilize cotton swab sticks to the area where drain point monitoring to be done as per schedule.
With taking precautions remove the sterilized cotton swab stick from its primary packing and insert the stick into tubes containing the diluent.
Ready-to-use swab tubes with cotton swab sticks (Make: Hi-Media) may also be used.
Mark the tubes for details of “Date of sampling, Sampling I.D, Location: Area where drain point monitoring to be done & Unit: “I’ & take it to the area where drain point monitoring to be done.
Now take out the cotton swab stick from the diluent and squeeze the access liquid from the cotton swab by pressing it on the side wall of tubes.
Take a swab of the drain point internal surface to cover the maximum area approx. 5’ x 5’ (25 cm²) area, uniformly & horizontally in one direction. After sampling, cleaned the swab area with filtered 70 % IPA.
Swabbing should be on the basis of risk factor so also take the swab of most un-cleaned area of drain point.
Take back the swab stick to the diluent and transfer to the micro lab for microbial analysis.
Now transfer this swabbed diluent to MLT area and vortex the swabbed diluent for at least one minute under Laminar air Flow.
Now filter this swabbed diluent through 0.45 µ filter and rinse with 100 ml Buffer Sodium Peptone Water then place this filter on Pre-incubated Soybean Casein Digest agar plate aseptically.
Incubate the plate at 20-250C for 72 hours followed by 48 more hours at 30-350C.
Record the observation.
Action During Out of Limit
In case, the CFU results are out of limit, inform to Quality Assurance Department in written.
Trend Preparation
Trend data Analysis of Drain Point Monitoring shall be prepared Annual in excel file.
Alerts and action limits of each sampling point shall be evaluated with following formula
Alert limit = Average + 2 σ (Where σ is standard deviation)
Action Limit = Average + 3 σ (Where σ is standard deviation)
To draw a meaningful conclusion, from the acquired data, all the results shall be Subjected to the basic calculations, (but not limited to these) alert, action, minimum & maximum.
The annual Summary report shall be prepared based on the trend by the data obtained for the entire year.
The Annual Trend Summary report shall contain (but not limited to) following contents.
- Approval Signatures
- Objective
- Scope
- Annual Trend Data
- Summary & Conclusion
- Recommendation
Annual Trend Data of the current year shall be prepared within 2 months of upcoming Year & detect the alert limit and action limit.
