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SOP On Operation of Halogen Moisture Balance

  •  Objective:To lay down the Operating procedure for Halogen Moisture Balance.
  • Scope:This standard operating procedure shall be applicable for formulation plant of Pharmaceutical company name with location.

Make: Mettler Toledo.

  • Responsibility
    • Trained worker / Operator shall be responsible for operating of the equipment as per this SOP.
    • Production Supervisor / Officer shall be responsible for implementation of this SOP.
    • Head-Production / designee shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

SOP  Standard Operating Procedure

QA –  Quality Assurance

  • Procedure
    • Switch ‘ON’ the apparatus by pressing ON/OFF key.
    • All the sign & codes appear on the screen.
    • Display shows initial status of closed automatic sampler with the sign  ┬
    • Press OPEN / CLOSE key automatic sample chamber open.
    • Screen shall start flash and indicating for tarring for sample pan.
    • Now put the sample pan on the pan handler and by pressing Tare key(O/T ) tare the sample plan.
    • After tarring display indicating for loading the sample.
    • Take uniform granules up to 2-3 gm.
    • Press ‘START’ key automatic sampler chamber close and instrument start drying.
    • end of the drying automatic sampler chamber open with buzzer sound.
    • Display shows the moisture content.
    • Press the ‘RESET’ key to delete the measurement result from display.
    • Now instrument is ready for next operation.
    • Press the «0—9» key and enter the desired drying temperature- either with scroll up and down key and confirm the setting by press ‘ENTER’ key.
    • Drying program select by pressing “Drying Program Key” display shows
    • Press display mode and select on 0►-100 setting.
    • Print shall be obtained at different interval. The time of interval selected on the screen by pressing ‘Print Interval’.
    • Press Print key print shall be obtained.
  • Forms and Records
    • Not Applicable
  • Distributions
    • Master Copy – Documentation Cell (QA)
    • Controlled Copies – Production and Quality Assurance
  • History
Date Revision

Number

Reason for revision
        – 00 New SOP

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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