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    Sterility Test Procedure

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    Musyoka Urbanus
    The document provides the standard operating procedure for sterility testing of medical products at Revital Healthcare. It outlines the testing process which involves incubating product samples in fluid thioglycollate medium and soybean casein digest medium for 14 days to check for microbial growth. If no growth is observed in the product samples or negative controls, but growth occurs in the positive controls, the test results show the products pass sterility testing. The SOP was approved by the quality control microbiologist, quality assurance manager, head of quality, and company director.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Sterility Test Procedure

    Uploaded by

    Musyoka Urbanus
    1K views7 pages
    The document provides the standard operating procedure for sterility testing of medical products at Revital Healthcare. It outlines the testing process which involves incubating product samples in fluid thioglycollate medium and soybean casein digest medium for 14 days to check for microbial growth. If no growth is observed in the product samples or negative controls, but growth occurs in the positive controls, the test results show the products pass sterility testing. The SOP was approved by the quality control microbiologist, quality assurance manager, head of quality, and company director.

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    STERILITY TEST PROCEDURE

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    The document provides the standard operating procedure for sterility testing of medical products at Revital Healthcare. It outlines the testing process which involves incubating product samples in fluid thioglycollate medium and soybean casein digest medium for 14 days to check for microbial growth. If no growth is observed in the product samples or negative controls, but growth occurs in the positive controls, the test results show the products pass sterility testing. The SOP was approved by the quality control microbiologist, quality assurance manager, head of quality, and company director.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    1K views7 pages

    Sterility Test Procedure

    Uploaded by

    Musyoka Urbanus
    The document provides the standard operating procedure for sterility testing of medical products at Revital Healthcare. It outlines the testing process which involves incubating product samples in fluid thioglycollate medium and soybean casein digest medium for 14 days to check for microbial growth. If no growth is observed in the product samples or negative controls, but growth occurs in the positive controls, the test results show the products pass sterility testing. The SOP was approved by the quality control microbiologist, quality assurance manager, head of quality, and company director.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    You are on page 1of 7

    REVITAL HEALTHCARE (EPZ) LTD.

    STANDARD OPERATING PROCEDURE


    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

    STERILITY TESTING PROCEDURE.


    APPROVED BY: SIGN & DATE
    Mariannah Kimatu
    (Quality control-Microbiologist)
    (Prepared By)

    Nancy Mwangi
    (Ass. Quality Assurance Manager)
    (Reviewed By)  
     
    Lucy caster Muoti
    (Quality Assurance Manager)
    (Reviewed By)  
     
    Vikrant Chowgule
    (Head Quality)
    (Approved By)  
     
    Ankur Vora
    (General Manager/Director)
    (Approved By)  

    REVISION HISTORY

    P a g e 1 of 7
    REVITAL HEALTHCARE (EPZ) LTD.
    STANDARD OPERATING PROCEDURE
    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

    Revision No. Revised Page(s) Description Date


    00 Original issue 01/09/2018
    01 All Revising 01/09/2019
    history,Header,Footer,
    content.
    02 All Footer, Header Content. 01/05/2021

    PURPOSE:
    This SOP provides guidelines for Sterility Testing of products subjected to sterilization.

    P a g e 2 of 7
    REVITAL HEALTHCARE (EPZ) LTD.
    STANDARD OPERATING PROCEDURE
    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

    SCOPE:
    The tests for sterility is intended for detecting the presence of viable forms of microorganisms in the
    reported sterilized products.

    The tests must be carried out under conditions designed to avoid accidental contamination of the product
    during the test.

    RESPONSIBILITIES:
    QC, Microbiologist is responsible for executing the process.
    QA oversees that the operating procedure has been followed.

    MEDIA FOR TESTING


     Fluid Thioglycollate Medium (FTM)
     Soybean Casein Digest Medium(SCDM)

    QUANTITY OF SAMPLE TO BE TESTED


     20 Pieces sampled from 100 pieces per batch.

    MATERIAL APPARATUS:
     Sterile forceps
     Sterile scissors
     Sterile test tubes(or flask)
     Sterile gloves
     Sterile mask
     70% IPA
     Clean bench
     Biological indicator-sterile and unsterile

    PRELIMINARY REQUIREMENT
     The microbiologist staff must sanitize the sterility testing room in accordance with cleaning
    procedure to assure its cleanness monthly.

    P a g e 3 of 7
    REVITAL HEALTHCARE (EPZ) LTD.
    STANDARD OPERATING PROCEDURE
    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

     Wash hands by using soap and disinfectant, respectively.


     Switch”ON the UV Lamp in Bio Safety Cabinet and expose it for minimum of 17 minutes.
     Transfer the test samples through Passbox, sanitize using 70%IPA and place it in the Bio Safety
    cabinet.
     Turn off UV lamp and warm up for 3 minutes, before testing.
     Dress the sterility testing uniform including sterile gloves and mask as well, then enter into the
    sterilty testing room.
     Disinfect outside of product package by spraying with 70% IPA and place them in clean bench.
     Incinerate the media tube/flask mouth while opening and closing.
    TEST PROCEDURE

    PRODUCT PROCEDURE
    Syringe Open the individual package under Bio Safety Cabinet and separate parts of
    syringe into barrel, plunger, gasket and the needle by using pre sterilized
    forceps, then immerse them into the culture media without external
    contamination.
    Infusion Set Open the individual package under Bio Safety Cabinet and then take out
    Infusion set using pre sterilized forceps, and using forceps remove the protector
    from needle and transfer the protector into the culture media test tube.
    Separate the wing from the set by cutting with pre sterilized scissor and transfer
    into culture media tube.
    Finally cut the tube of the set into small pieces with scissors and transfer into
    the culture media tube.
    Blood tubing Open the individual package aseptically under Bio Safety Cabinet, choose the
    set portion of the blood line which is difficult to sterilize, cut these portions and
    immerse them into the culture medium.
    Catheter Open the individual package under the Bio Safety Cabinet and separate parts of
    the catheter by using pre sterilized forceps and scissors, and immerse them into
    the culture medium.
    Specimen Open the individual package under Bio Safety Cabinet using pre sterilized
    collection forceps, then immerse the swab into the culture media without external
    swabs contamination.
    (oral/nasal)

    P a g e 4 of 7
    REVITAL HEALTHCARE (EPZ) LTD.
    STANDARD OPERATING PROCEDURE
    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

    INCUBATION

     After proper marking for identification all the FTM and SCDM test tube run the test sample
    together with biological indicators. One for the positive control which contains unsterilized
    biological indicator (Bacillus spp.) and negative control containing sterilized biological indicator
    incubate at 30°C-35°C and 20°C-25°C respectively for not less than 14 days.

    S.N NAME OF MICROBIAL CULTURE INCUBATION


    O. MEDIA TEMPERATURE
    1. FTM (Aerobic bacteria) 30°C-35°C
    S.aureus ATCC 6538
    B.subtilis ATCC6633
    P.aeruginosa ATCC 9027
    2. SCDM B.subtilis ATCC 6633 30°C-35°C
    C.albicans ATCC 10231 20°C-25°C
    A.niger ATCC 16404 20°C -25°C

    OBSERVATION AND INTERPRETATION OF THE RESULTS.


    Observe the incubated tubes daily for the microscopic evidence of microbial growth. Record the
    observation, the specimen complies with test results if :

    P a g e 5 of 7
    REVITAL HEALTHCARE (EPZ) LTD.
    STANDARD OPERATING PROCEDURE
    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

     No sign of growth is observed in the specimen tube till the 14th day.
     No sign of growth is observed in the negative control.
     No sign of growth is observed in test media negative control.
     Growth is observed in bacterial positive control within 3 days.
     Growth is observed in fungal positive control within 5 days.
     Media used should have passed growth promotion test.
    The test maybe considered invalid only if one or more of the conditions are fulfilled.
     The data of microbiological monitoring of the sterility testing facility shows a fault.
     Microbial growth is found in negative controls.

    Note:
    If the test is declared to be invalid it is repeated with the same number of units as in the original test. If
    no evidence of microbial growth is found in the repeat test, the product examined should comply with
    the test for sterility and if growth is found, the product does not comply with the test for sterility.
    REFERENCE:
     The United States Pharmacopeia (current revision).
     The Pharmacopeia of Japan (current revision)

    ABBREVIATIONS

    SOP: standard operating procedure

    QA: Quality Assurance

    QC: Quality Control

    UV: Ultra Violet

    IPA: Isopropyl Alcohol

    P a g e 6 of 7
    REVITAL HEALTHCARE (EPZ) LTD.
    STANDARD OPERATING PROCEDURE
    T I T L E :SOP FOR STERILITY TESTING

    PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:


    RHEL/QA/SOP/76 01/05/2021 01/05/2021 01/05/2023

    REVISION NO.:02

    SPP: Species

    FTM: Fluid Thioglycollate Medium

    SCDM: Soybean Casein Digest Medium

    P a g e 7 of 7

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