SOP of Temperature Monitoring of Microbiology Equipments

SOP On Temperature Monitoring of Microbiology Equipment’s

  • Objective

To lay down the procedure for Temperature Monitoring of Microbiology Equipment’s.

  • Scope

This SOP is applicable for Temperature Monitoring of Microbiology Equipment’s like incubators and refrigerator in Microbiology Laboratory of (Pharmaceutical Company Name).

  • Responsibility
    • Microbiologist or above of Microbiology Laboratory: Preparation of SOP.
    • Head – Microbiology section / Nominee: Checking of the SOP.
  • Accountability
    • Head – Quality Control / Nominee: Compliance of SOP.
  • Abbreviations and Definitions

SOP                             : Standard operating procedure

No.                              : Number

QC                              : Quality Control

QA                              : Quality Assurance

  • Procedure
    • Monitor chamber temperatures of equipment’s like all incubators and refrigerator twice in a day (Morning and evening).
    • Use a calibrated thermometer to check the temperature inside these equipment’s.
    • Place the thermometer at the center of the equipment chamber and keep for two minutes.
    • Remove the thermometer and observe the temperature reading after two minutes and record as per Annexure No.
    • Check and record the display ‘PV’ (process value-temperature) on the temperature controlling panel if available.
    • Observe whether both display temperature and temperature monitored by calibrated thermometer are within the set temperature range or not.
    • If any abnormality is observed, shift the material in to equipment, which is working well and send a work order to maintenance department through Head-Microbiology, to rectify the problem.
  • Forms and Records (Annexures)
    • Temperature Monitoring Record for Microbiology Equipment’s
  • 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

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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