BOD Incubator – Cleaning, Calibration, Operation

Standard Operating Procedure (SOP) for Operation, Cleaning and Calibration of Newtronic make BOD Incubator used in microbiology department for analytical activity.

BOD Incubator

1.0   Purpose:

    • To lay down the procedure for Operating, Calibration and Cleaning of BOD Incubators Model No.: NEC134 RTSSI.

2.0   Scope:

    • This Standard Operating Procedure is applicable at Microbiology section of Quality Control department of pharmaceuticals.

3.0   Responsibilities:

    • Microbiologist / Executive – Quality control.
    • Responsible for the Operation, Calibration and Cleaning of the BOD incubators.
    • Quality Control (QC) Head.
    • Ensure proper control and compliance of the SOP.
    • Quality Assurance (QA) Department:
    • To review the SOP.
    • To ensure the implementation of SOP.
    • Regulatory Affairs, Quality Head and Plant Head :
    • To review and approve new or revised SOPs.

4.0   Procedure – Operation, Calibration and Cleaning of BOD Incubator:

    • Operation of BOD Incubator :
    • Switch ‘ON’ the main power supply of required chamber and set the temperature by using ICDAS software.
    • Operation of Controller
      • SET/Select Key
      • SCROLL KEY (Down for Change Set Parameter)
      • SCROLL KEY (Up for Change Set Parameter)
      • ENTERL KEY (Press for Change Set Parameter)
      • 1   > 43.1 = Measured Temperature in ºC
      • COM1      = Compressor
      • ALM        =  Alarms
    • As main supply is switched on, the controller display will show window by pressing up arrow key one can see window

      • Default window. By pressing up arrow key window will be displayed.
      • Set temperature and alarm limits in °C
      • Scanner (4 channels) reading in °C
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      • PID parameters for temperature accuracy
      • Time in HH:MM:SS
      • Date in DD/MM/YY format
    • To acknowledge an alarm push the ENTER KEY along with Down SCROLL KEY.
    • Check the temperature in digital display whether it is showing the desired temperature or not.
    • In case of any variation set it to the required with scroll up and down keys or by IC DAS 1.2 Software.

 

INCUBATOR ID NO. SET TEMPERATURE ACCEPTANCE TEMPERATURE
32.50C 30-350C
22.50C 20-250C

 

    • BOD Incubator shall run through software IC DAS -version 1.2.

 

    • Click on the icon and enter Login name and Password.
    • Check all details i.e. Real Time display, Real Time summary, Inputs & Outputs, Alarm Log, Report, Equipment setting and Equipment Data Log Report.
    • All alarms shall be acknowledged after checking of reason(s) of alarm (Mains fail, etc.) regularly.
    • Take printout of Data log of Temperature on daily basis.
    • If the temperature recorded is out of specification inform engineering department to take the corrective action.
    • Only authorized person shall be allowed to open the chambers as per annexure-2.
    • Details of BOD incubator.
    • Loading and Unloading of Samples in BOD Incubator :

    • Unlatch the door of the BOD incubator, locate the place to keep/remove the sample and load/unload the samples and close the door.
    • Make sure that the door is properly latched, otherwise temperature will leak and accuracy will not be maintained.
    • Lock the door.
    • During sample placement while loading or unloading, the following should be observed.
    • Sample has to stay in the confined area of tray.
    • Free space on the side of the trays should not be blocked by the sample.
    • Air circulation holes should not be blocked.
    • Sensor should not be covered with samples.
    • Shutdown of BOD Incubator :

    • In case a BOD incubator is to be shutdown, the main switch of the BOD incubator is to be switched ‘OFF’. Nothing else is necessary.
    • When the temperature will fall below low alarm limit, it will generate an alarm. Acknowledge the alarm.
    • Cleaning of BOD Incubator :

    • For cleaning of inside the BOD incubator, shift the incubated items placed on the tray on half portion of the tray.
    • Clean the walls of incubator and surface of the tray with wiping of IPA 70 %.
    • Shift the items on the cleaned portion of tray and then clean the remaining portion of tray and walls with IPA 70%.
    • Clean all the trays following the procedure mentioned above.
    • Record the cleaning activities as per the Annexure 1.
    • Frequency: Once in a Week.
    • Calibration/Validation of BOD Incubator.

    • Note: Executive/ Officer- Microbiology shall inform the out side agency selected for calibration/Validation as per the schedule for performing the calibration as per the plan mentioned below.
    • Take one calibrated certified thermocouple Data logger.
    • Place eight calibrated thermocouple sensors in Incubator as per the location Diagram attached as Annexure-3.
    • Operate the incubator as per the above operating procedure.
    • Take the readings from each thermocouple at an interval of 10 minutes and record the results up to 24 hours.
    • Attach the printouts of temperature readings with the report of calibration.
    • Calibrate the sensor of BOD incubator with a calibrator.
    • After successfully completion of activity pest the calibration status label as per Annexure-4.
    • Frequency of calibration
    • Yearly
  • Abbreviations:
    • BOD : Biochemical Oxygen Demand
    • IPA : Iso Propyl Alcohol
    • PID : Proportional Band, Integral Time, Derivative time
    • QA    : Quality Assurance
    • QC : Quality Control
    • RTD : Resistance Temperature Detectors

5.0   Annexures – BOD Incubator:

Annexure-1 :  Cleaning Record of BOD Incubator.

S. No.

Date  Instrument ID Time of Cleaning Cleaned by Checked by

Remarks

From

To

Annexure-2 :  List of Authorized Person

  NAME OF INSTRUMENT: BOD INCUBATOR
EQUIPMENT ID. :
S.N.  NAME OF PERSON
   
   

Annexure-3 :  Diagram for location of thermocouple in BOD Incubator

BOD Incubator Validation

Annexure-4 :  Calibration status label.

CALIBRATION STATUS LABEL

Name of Equipment  
Equipment ID  
Date of Calibration  
Next Due Date  
Calibration Done By  

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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