Blog

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

• • • 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.

• • 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

• • CC : Change Control

• • 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.

Annexure-2 :  List of Authorized Person

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

Annexure-4 :  Calibration status label.

***************************************END***************************************