Procedure for using of Molybdenum Kit

Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel.

Procedure for using of Molybdenum Kit

1.0      PURPOSE:

    • The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum kit.

2.0      SCOPE:

    • This SOP is applicable for Material of Construction (MOC) testing of all newly received processing equipment’s contact parts and non-contact parts in the pharmaceutical manufacturing plant.

3.0      REFERENCES:Molybdenum Kit

    • Molybdenum kit manufacturer’s specification

4.0      RESPONSIBILITY (USING OF MOLYBDENUM KIT):

    • The user department shall be responsible to provide the test equipment in clean and dry conditions to carry out the MOC test.
    • The user department shall be responsible to document the observation on the respective column of the protocol.
    • The engineering department shall be responsible to perform the test to determine the MOC of the contact part and non-contact part of the equipment.
    • Quality Assurance shall be responsible To ensure that the test shall be carried out as per the defined procedure.
    • Officer or Executive of the respective department shall be responsible for the preparation of new or revision of existing SOPs.
    • Department Head shall be responsible to ensure that the test shall be performed as per the defined procedure.
    • QA Head and Quality Head shall be responsible to review and approve the SOP.

5.0      ABBREVIATIONS:

    • MOC: Material of Construction
    • NA: Not Applicable
    • QA: Quality Assurance
    • SOP: Standard Operating Procedure

6.0      PROCEDURE USING OF MOLYBDENUM KIT:

    • Put one drop of solution on the clean and dry metal surface to be tested.
    • Pass 9v current (-) ve pole on the chemical drop.
    • Remove 9v current from the chemical drop after observing the color change of the solution.
    • If the color changes to reddish-brown color and remains for a long time then the tested metal is SS 316 grade.
    • If the color changes to reddish-brown color and disappears immediately, then the tested metal is SS 304.
    • Record the observations on the respective column of the Qualification protocol of the tested equipment.

7.0      DISTRIBUTION:

    • Quality Assurance
    • Maintenance
    • User Department

8.0      ANNEXURES: NA

 

pharmabeginers

Niranjan Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an updated pharmaceutical blogging platform. Email: [email protected]

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