SOP on Operation, Calibration, Cleaning and Maintenance of BOD Incubator

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1.0 Objective:

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

2.0 Scope:

This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of BOD Incubator in Microbiology Laboratory at pharmaceutical formulation plant.

3.0 Responsibility:

Microbiologist or above of Microbiology Laboratory.

Head – Microbiology section / Nominee.

4.0 Accountability:

Head – Quality Control / Nominee.

5.0 Abbreviations:

SOP : Standard operating procedure

No. : Number

QC : Quality Control

QA : Quality Assurance

6.0 Procedure:

Make: Thermolab

6.1 Operation:

6.1.1 Ensure that the power cord is connected to the incubator. Switch on the mains.

6.1.2 Switch on the Mains and the cooling buttons 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.

6.1.3 Operation of Temperature Controller:

6.1.3.1 For setting of temperature, Press SEL key on the temperature controller.

6.1.3.2 Go to the option LOC and change the number to 0, which means open.

6.1.3.3 Come back to the original display by pressing the SEL key for few seconds.

6.1.3.4 Change the settings to the required temperature if necessary using increment and decrement key. Again lock the Display settings panel by going back to LOC and changing the number to 1.

6.1.3.5 Set the safety thermostat at 5˚C above the set temperature on the temperature controller.

6.1.4 Operation of Printer / PC Interface panel:

6.1.4.1 Press SEL key on the display unit, ‘DISPLAY NO.’ will flashed on the screen. Set the value as ‘01’ using increment and decrement key and press enter icon.

6.1.4.2 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.

6.1.4.3 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.

6.1.4.4 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. If print data is required continuous then enter the value as ‘0’.

6.1.4.5 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, decrement key, and then press enter.

6.1.4.6 Press SEL key again, ‘PRINT DATE DATA’ will appear on the screen. 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, using increment and decrement key and then press enter.

6.1.4.7 Press SEL key again, ‘PRINT CONTROL’ will be displayed on the screen. These are a series of 7 sub functions which are required only during printing.

6.1.4.1.7.1 ‘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.

6.1.4.1.7.2 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.

6.1.4.1.7.3 Press increment key again, ‘PRINT CONTROL STOP OLD PRINT’ will appear on the screen. Press enter key to stop the previous pages under printing.

6.1.4.1.7.4 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.

6.1.4.1.7.5 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.

6.1.4.1.7.6 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.

6.1.4.1.7.7Press increment key again, ‘PRINT CONTROL RESET ALL MEMORY’ will appear on the screen. Do not reset the memory unless required.

6.1.4.1.7.8 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.

6.1.4.1.7.9 Press SEL key again. The message appearing will show ‘PRINT MEMORY PC MEMORY’ which has been used up till date.

6.1.4.1.7.10 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.

6.1.4.1.7.11 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, so that an alarm indication appears if any one of the two memories goes above 70%.

6.1.4.1.7.12 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.

6.1.4.1.7.13 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.

6.1.5 Operation of Scanner:

6.1.5.1 Follow the steps no. 6.1.4.1 to 6.1.4.10 and set the same parameters for the scanner.

6.1.5.2 Press SEL key again, ‘CHANNEL GR NO.’ will appear on the screen. Press SEL key again.

6.1.5.3 ‘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.

6.2 Calibration:

6.2.1 Calibration shall be performed for Temperature controller, Sensors and Safety thermostat by the external party once in a year.

6.3 Cleaning of Incubators:

6.3.1 Internal cleaning:

6.3.1.1 Switch OFF the mains of the incubator.

6.3.1.2 Disconnect the plug of the equipment.

6.3.1.3 Open the door and transfer the material into other incubator of equal temperature.

6.3.1.4 Take out the trays from the equipment and place it in a safe place.

6.3.1.5 With the help of lint free cloth and disinfectant, clean the entire internal surface of the incubator and allow it to dry as per respective SOP.

6.3.1.6 Clean the trays with the cloth and disinfectant and then keep the trays and the material back into the incubator.

6.3.1.7 Use the disinfectant for cleaning on rotation basis and maintained the record in the Annexure No.-I.

6.3.1.8 Connect the plug of the equipment.

6.3.1.9 Switch on the main switch to which the equipment is plugged.

6.3.1.10 Switch ON the incubator.

6.3.1.11 Frequency: Once in a week.

6.3.1.12 External cleaning:

6.3.1.13 Clean the external surface using a lint free cloth with disinfectant.

6.3.1.14 Frequency: Daily

6.4 Maintenance:

6.4.1 Clean the chamber from inside and outside after use.

6.4.2 Clean the PT-100 sensor tip with the help of a smooth polish paper every 2 months.

6.4.3 Clean the condenser by blowing air through it after every 2 months.

6.4.4 Check the chamber fan and condenser fan, if found loose, tighten it.

6.4.5 Check the working of the safety thermostat.

6.4.6 Check the drainpipe provided at the bottom of the chamber.

6.4.7 Record the details of usage in the in the BOD Incubator Log Book as per Annexure No.-I.

7.0 List of Annexure / Formats:

BOD Incubator Log Book

8.0 References (if any):

BOD Incubator Manual

9.0 Distribution

9.1   Master Copy                                     : Documentation Cell (Quality Assurance)

9.2   Controlled Copies                            : Quality Assurance, Microbiology-QC

10.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

Annexure-I

BOD Incubator Log Book

Incubator I.D.No.:

Incubation started on Micro. Ref. No Medium placed Number of plates/ tubes/ bottles Purpose Incubated       by Incubation completed        on Observed     by Remarks

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