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SOP on Operation, Calibration, Cleaning and Maintenance of Hot Air Oven

  • SOP on Operation, Calibration, Cleaning and Maintenance of Hot Air Oven
  • Objective

To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven.

 Scope

This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven in Microbiology Laboratory of (Pharmaceutical Company Name).

  • Responsibility
    • Officer or above of Microbiology Laboratory.
    • Head – Microbiology section.
  • Accountability
    • Head – Quality Control. / Nominee.
  • Abbreviations and Definitions

SOP         : Standard operating procedure

No.            : Number

QC            : Quality Control

QA            : Quality Assurance

  • Procedure
    • Operation
      • Load the material to be sterilized or depyrogenated or dried, on the trays provided within the oven, close the door and tighten it with the clamps provided.
      • Connect the plug to the power source and switch on the power.
      • Switch on the mains of oven.
      • LED lamp for the power indicator will glow.
      • Switch on the fan of the oven.
      • Press and hold the red button given in the temperature control box which will display the pre-set temperature.
      • Set required temperature (250 0C for depyrogenation and 100 0C for drying) using COURSE and FINE temperature adjustment knobs.
      • Rotate the arrow mark of energy regulator knob from OFF position to LOW, MEDIUM or HIGH position according to the temperature requirement and urgency, to reach the required temperature.
      • Heaters will start, the LED for heating will start glowing and the temperature rises steadily to the Set temperature.
      • Note the time at which the set temperature is reached.
      • Consider the Hold time from the reach of Set Temperature for Depyrogenation Cycle.
      • After completion of sterilization and depyrogenation or drying, switch off the MAINS and the power source.
      • Record the usage details in the format No.: as per Annexure No.:
    • Cleaning:
      • Switch OFF the Hot air oven.
      • Switch off the mains to which the equipment is plugged.
      • Disconnect the plug of the equipment.
      • Allow the equipment to cool if the temperature is high.
      • Take out the materials available in the equipment and place it in tray disinfected with 0.2µm filtered 70% IPA.
  • Take out the trays from the equipment and place it in a safe place.
  • Take a lint free cloth and dip it in disinfectant solution.
  • Squeeze the cloth and use.
  • Clean the internal surface of the equipment.
  • Clean the trays as per the above procedure.
  • Mop the surface with a dry lint free cloth.
  • Place the trays in their original position and place the material within

the equipment as per the requirement.

  • Connect the plug of the equipment.
  • Switch on the mains and operate if required.
  • Cleaning frequency
    • Once a Week.
  • Calibration
    • Calibration of the temperature controller and sensor shall be done by external

party once in every 6 months.

  • Forms and Records (Annexures)
    • Hot air oven Log Book
  • Distribution
    • Master copy        –       Quality Assurance
    • Controlled copies –       Quality Assurance, Production, Quality Control, Stores, Engineering   and Human Resource
  • 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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