SOP for Microbial Testing of Drain Water | Pharmaguideline
  •   Pharmaguideline Courses Start Learning
  • Apr 17, 2021

    SOP for Microbial Testing of Drain Water

    Standard operating procedure to determine the microbial contamination in drain water.

    1.0 OBJECTIVE

    To lay down the procedure for Microbial testing of drain water in the production area.

    2.0 SCOPE

    This SOP shall be applicable to Quality Control Dept.

    3.0 RESPONSIBILITY

    Microbiologist

    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 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% Soy lecithin 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
    Get editable documentsView List

    No comments:

    Post a Comment

    Please don't spam. Comments having links would not be published.


    Popular Categories ๐Ÿท️

    QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
    Online Courses Salary Calculator
    Follow on Whatsapp


    Certificate Courses ๐ŸŽ–️

    Pharmaceutical Courses

    Follow Pharmaguideline


    DOCUMENTS ๐Ÿ“‹

    PHARMACEUTICAL DOCUMENTS




    Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

    View


    adsbypg


    GET APP FOR NEWS UPDATES


    Android App