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Operation, Calibration, Cleaning and Maintenance of Bacteriological Incubator

Operation, Calibration, Cleaning and Maintenance of Bacteriological Incubator

  • Objective

To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of Bacteriological Incubator.

  • Scope

This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of bacteriological Incubator in Microbiology lab (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

Make: Thermo lab

  • Operation:
    • Ensure that the power cord is connected to the incubator. Switch on the mains.
    • Switch on the Mains switch provided on left side of the incubator. Temperature controller unit will show the Set Value (SV) temperature and Process Value (PV) temperature of the incubator.
    • Operation of Temperature Controller:
      • For setting of temperature, Press SEL key on the temperature controller.
      • Go to the option LOC and change the number to 0, which means open.
      • Come back to the original display by pressing the SEL key for few seconds.
      • Change the settings to the required temperature if necessary using increment and decrement key. Again lock the Display settings panel by entering to LOC 1
      • Set the safety thermostat at 5˚C above the set temperature on the temperature controller.
    • Operation of Printer/PC Interface panel:
      • Press SEL key on the display unit, ‘DISPLAY NO.’ will flash on the screen. Set the Value as ‘01’ using increment and decrement key and press enter icon.
      • Press SEL key again, ‘SET TIME DATE’ will appear on the screen with time and date mentioned below. If required set the correct date and time using increment and decrement key and then press enter.
      • Press SEL key again, ‘PRINT INTERVAL’ will appear on the screen. Set the time to 15 min. using increment and decrement key and then press enter key.
      • Press SEL key again, ‘PAGE LENGTH’ will appear on the screen. Set the page length to ‘68’ using increment and decrement key and then press enter key. In case print data is required continuous then enter the value as ‘0’.
      • Press SEL key again, ‘PRINT PAGE #’ will appear on the screen. Set the required number depending on the no. of old pages for which you want the print using increment and decrement key and then press enter.
      • Press SEL key again, ‘PRINT DATE DATA’ will appear on the screen. Using increment and decrement key enter the required date and select the required option i.e. ‘ONE’ if print is required for that date only or ‘NEXT’ if print is required from that date onwards, and then press enter key.
      • Press SEL key again, ‘PRINT CONTROL’ will be displayed on the screen. These area series of 7 sub functions which are required only during printing.
        • ‘PRINT CONTROL SET PAGE’ is the first sub function displayed on the screen. Press enter key if a header is required at the beginning of the page.
        • Press increment key, ‘PRINT CONTROL PRINT CURRENT’ will appear on the screen. Press enter key to take a print of the current value of the temperature.
        • Press increment key again, ‘PRINT CONTROL STOP OLD PRINT’ will appear onthe screen. Press enter key to stop the previous pages under printing.
        • Press increment key again, ‘PRINT CONTROL RESET PAGE NO.’ will appear on the screen. Press enter key to reset the page no. to 01 before taking a print.
        • Press increment key again, ‘PRINT CONTROL RESET PRINT’ will appear on the screen. Press enter key if you want to reset the stored print data.
        • Press increment key again, ‘PRINT CONTROL RESET DSU UNIT’ will appear on the screen. Do not press enter key as it will reset DSU hardware.
        • Press increment key again, ‘PRINT CONTROL RESET ALL MEMORY’ will appear on the screen. Do not reset the memory unless required.
      • Press SEL key again, ‘PASSWORD-V 6.4F’ will appear on the screen. Enter the correct password to login using increment and decrement key and then press enter.
      • Press SEL key again. The message appearing will show ‘PRINT MEMORY PC MEMORY’ which has been used up till date.
      • Press SEL key again, ‘DSU NO.’ will appear on the screen. Enter a specific DSU No. for the incubator using the increment and decrement key.
      • Press SEL key again, ‘MEM ALARM PROG’ will appear on the screen. Set the option to PRINT + PC MEM’ using increment and decrement key and press enter key.
      • Press SEL key again, ‘CONTROLLER NO.’ will appear on the screen. Select the specific controller no. for which you want the data display on the screen. Use increment and decrement key to select required controller no. and then press enter key.
      • Press SEL key again, ‘DISPLAY ALL’ will appear on the screen. Set the value as ‘01’ using increment and decrement keys and then press enter key.
    • Operation of Scanner:
      • Follow the steps no. 6.1.4.1 to 6.1.4.10 and set the same parameters for the scanner.
      • Press SEL key again, ‘CHANNEL GR NO.’ will appear on the screen. Press SEL key again.
      • ‘DISPLAY ALL’ will appear on the screen. Set the value as ‘01’ so that it shows the parameters of two controllers at the same time, and then press enter key.
    • Calibration:
      • Calibration shall be performed for Temperature controller, Sensors and Safety thermostat by the outside party once in a year.
    • Cleaning of Incubators:
      • Internal cleaning:
        • Switch OFF the mains of the incubator.
        • Disconnect the plug of the equipment.
        • Open the door and transfer the material into other incubator of equal temperature.
        • Take out the trays from the equipment and place it in a safe place.
        • With the help of lint, free cloth and disinfectant clean the entire internal surface of the incubator and allow it to dry.
        • Clean the trays with the cloth and disinfectant. Then keep the trays and the material back into the incubator.
        • Connect the plug of the equipment.
        • Switch on the main switch to which the equipment is plugged.
        • Switch ‘ON’ the incubator.
        • Frequency: Once a week.
      • External cleaning:
        • External surface is cleaned using a lint free cloth and disinfectant.
        • Frequency: Daily
  • Maintenance:
    • Clean the incubator from inside and outside.
    • Clean the PT-100 sensor tip with the help of a smooth polish paper every 2 months.
    • Clean the condenser by blowing air through it after every 2 months.
    • Check the chamber fan and condenser fan, if found loose, tighten it.
    • Check the working of the safety thermostat.
    • Check the drainpipe provided at the bottom of the chamber.
    • Record the details of usage in the in the Incubator Usage Record as per Annexure No.
  • Forms and Records (Annexures)
    • Bacteriological 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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