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:
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- 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:
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- 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:
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- Molybdenum kit manufacturer’s specification
4.0 RESPONSIBILITY (USING OF MOLYBDENUM KIT):
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- The user department shall be responsible to provide the test equipment in clean and dry conditions to carry out the MOC test.
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- The user department shall be responsible to document the observation on the respective column of the protocol.
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- 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.
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- Quality Assurance shall be responsible To ensure that the test shall be carried out as per the defined procedure.
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- Officer or Executive of the respective department shall be responsible for the preparation of new or revision of existing SOPs.
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- Department Head shall be responsible to ensure that the test shall be performed as per the defined procedure.
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- QA Head and Quality Head shall be responsible to review and approve the SOP.
5.0 ABBREVIATIONS:
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- MOC: Material of Construction
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- NA: Not Applicable
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- QA: Quality Assurance
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- SOP: Standard Operating Procedure
6.0 PROCEDURE USING OF MOLYBDENUM KIT:
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- Put one drop of solution on the clean and dry metal surface to be tested.
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- Pass 9v current (-) ve pole on the chemical drop.
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- Remove 9v current from the chemical drop after observing the color change of the solution.
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- If the color changes to reddish-brown color and remains for a long time then the tested metal is SS 316 grade.
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- If the color changes to reddish-brown color and disappears immediately, then the tested metal is SS 304.
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- Record the observations on the respective column of the Qualification protocol of the tested equipment.
7.0 DISTRIBUTION:
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- Quality Assurance
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- Maintenance
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- User Department
8.0 ANNEXURES: NA
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