1.0 OBJECTIVE:To lay down the procedure for Microbial testing of drain water in production area.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 All drains in the production area shall be checked to monitor the effectiveness of cleaning and disinfecting agents once in a month.
5.2 Sample 100 ml of drain water from each drain and collect it in a sterile glass container with the help of previously sterilized pipette.
5.3 Following tests shall be performed on the drain water collected:
a) Total Microbial Count.
b) Absence of Pathogens.
5.4 Filter the sampled drain water through 0.45 membrane filter.
5.5 For Phenolic disinfectants, dilution of drain water with sterile distilled water and filtration through 0.45 micron is sufficient. However, whenever other types of disinfectants e.g. Quaternary ammonium compounds are used, deactivation of the same should be carried out with 0.5% Soylecithin and/or 4 % Polysorbate-20 (Tween 20), by addition of these compounds in culture media.
5.6 Wash the filter paper 5 times with sterile Normal Saline.
5.7 Inoculate the filter paper in 100 ml of Normal Saline.
5.8 Shake thoroughly (so that the contents of filter paper comes in Normal Saline).
5.9 Perform the Total Microbial Count and test for absence of Pathogens as per the standard. Count and record the results in Drain Water (Microbiological Testing) Record.
5.10 Necessary feedback shall be given to Production for corrective action, if required.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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