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Operation, Temperature verification, cleaning and maintenance of Dry Bath Incubator

Operation, Temperature verification, cleaning and maintenance of Dry Bath Incubator

  • Objective

To lay down a procedure for operation, calibration, cleaning and maintenance of Dry bath incubator

  • Scope

This SOP is applicable for operation, calibration, cleaning and maintenance of dry bath incubator in Microbiology Laboratory of (Pharmaceutical Company Name).

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

SOP                             : Standard operating procedure

No.                              : Number

QC                              : Quality Control

QA                              : Quality Assurance

IPA                             : Isopropyl Alcohol

  • Procedure
    • Operation:
      • Connect the power cord of the heating block to the electrical main switch.
      • Switch on the Mains and switch on the power supply of the heating block by pressing switch at the back of the heating block.
      • Gently place the blocks into the block chamber.
      • Place the Endotoxin tubes (10 x 75 mm) in to the wells of heating block.
      • Set the required temperature for performing the test, on the temperature controller using the shift, increment and decrement key and then press set key to for acceptance of that set value.
      • Set the required alarm mode using the alarm mode set-up.
      • After reaching the set temperature leave the test tubes for incubation for specified time limit without any vibration.
      • Record the operation details as per Annexure No.
    • Temperature Verification:
      • Set the required temperature i.e. 37°C for temperature verification.
      • Take 12 Endotoxin free reaction tubes (10 x 75 mm) and add approximately 0.5 ml of purified water in each tube.
      • Place the test tubes in the wells as per the diagram-1and allow to stand about few minutes for stabilize the water within the tubes.
      • Place a calibrated thermometer in one of the tube for few seconds and record the temperature and also note down the display temperature of heating block.
      • Take out and wipe the thermometer with the help of a tissue paper for cleaning the water droplets.
      • Continue this process for all the remaining eleven tubes of Dry Bath Incubator.
      • Record all the thermometer readings as well as heating block display temperature in Annexure- (Format No. :).
    • Precautions:
      • Place the heating block on a hard vibration free surface.
      • When incubation is in progress do not disturb the incubator or the table on which incubator is kept.
    • Frequency of Calibration: Once in a Month.
      • Acceptance Criteria:                   37 ± 1 º C.
    • Cleaning:
      • Clean the dry bath incubator using a damp soft cloth soaked in 70% IPA.
      • Clean the blocks using a mild detergent solution with soft brush and completely dry the blocks before placing it back into the equipment
    • Maintenance:
      • The blocks should be cleaned regularly.
      • Never cover the dust cover while operating and also until 45 minutes of switching off.
      • Maintain ambient environment temperature for better temperature control and accuracy of equipment.
      • Unplug the equipment’s main cable from mains while cleaning and if the equipment is not in use.

Diagram-1: Temperature Verification Locations

 

 

           
           
           
           
           

 

           
           
           
           
           

 

  • Forms and Records (Annexures)
    • Dry bath Incubator Log book
    • Dry bath Incubator 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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