SOP for Operation and Calibration BOD Incubator

This SOP is applicable at the time of the operation and calibration of the BOD incubator.

It is the policy of XYZ Limited that a written procedure shall be followed for the operation and calibration of the BOD incubator to ensure smooth operation and its use monitored to obtain consistent and reproducible results minimize downtime and meet regulatory requirements.

RESPONSIBILITY 

Persons along with their responsibilities and accountability are given below:

Executive  - Corporate Quality Assurance: To prepare the SOP. Maintain the record as per SOP. Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly. Manager - Corporate Quality Assurance:-To ensure implementation of SOP.

Operation and Calibration BOD Incubator 

5.1 Cleaning of  BOD incubator

5.1.1 Clean the instrument externally with clean Tissue Paper by using 70% Isopropyl Alcohol.

5.1.2 Clean the unit surface with a wiping cloth supplied with the unit before and after use.

5.2 PRECAUTION

5.2.1 Do the surface sterilization by 70% Isopropyl Alcohol twice/twice a week.

5.2.2  Open the door only at the time of requirement, do not open it frequently.

5.2.3 Ensure that the latch of the glass door is closed.

5.2.4 Do not overload the unit with samples.

5.2.5 Check the temperature regularly.

5.2.6 Keep the instrument in a room having constant temperature and away from any heating device.

5.3 OPERATION PROCEDURE

5.3.1 Ensure that the proper power supply is connected to the instrument.

5.3.2 Switch “ON” the instrument (if the Instrument is off).

5.3.3 Set the required temperature with the help of Coarse and finally with the help of fine adjustment.

5.3.4 Ensure that the temperature indicator/controller is in working condition i.e. the set temperature should be maintained/retained properly.

5.3.5 The digital display will show the desired temperature.

5.3.6 Ensure that the door of the incubator is properly closed and does not loosen during operation.

5.3.8 Ascertain and set the points at which calibration is required.

5.310 Maintain Logbook of BOD Incubator on XYZ/CQA/SOP-064/FR-01 as Log Book of BOD Incubator Appendix I

5.3.11 Maintain Daily temperature record of BOD Incubator on XYZ/CQA/SOP-064/FR-02as Daily Temperature record Appendix II.

Operation and Calibration of the BOD Incubator 25˚C  (TOSHIBA  L-7003)

6.0 CALIBRATION BOD INCUBATOR 

6.0.1 Calibration Frequency: Quarterly

6.0.2 A Calibrated Platinum resistance thermometer (PRT) with a sensor and digital temperature indicator Apparatus is required for the calibration of the BOD incubator

6.0.3 Insert the sensor of the reference/calibrator sensor (PRT) in the BOD incubator as near as possible to the sensing tip or sensor of the temperature controller/indicator of the BOD incubator.

6.0.4 SET THE TEMPERATURE FIRST AT 25˚C OF THE BOD INCUBATOR.

6.0.5 When the temperature is stable note down the temperature reading as displayed BOD incubator and the reference PRT Thermometer simultaneously.

6.0.6 Ensure that the observed temperature after stabilizing it should not differ ± 2 °C to the set temperature.

6.0.7 Record the temperature readings at 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours accordingly.

6.0.8 Correlate the readings observed with the PRT Thermometer displayed BOD Incubator and apply corrections, if necessary. 

6.0.9 Record the calibration data on XYZ/CQA/SOP-064/FR-03, Calibration Data Sheet Appendix III.

6.0.10 After the calibration of the instrument, affix the calibration status tag on the instrument and fill in all the required details as per SOP No. XYZ/CQA/SOP-006, Labeling Policy.

 6.0.11 Report any discrepancy observed during the operation and calibration of the instrument to the Section In-charge or his representative for corrective and preventive action.

6.0.12 Section In-charge or his representative will take the necessary action and report the same to the Manager – Quality Assurance.

6.0.13 Affix Out of Order on BOD Incubator.

7.0 GENERATION OF INSTRUMENT CALIBRATION NUMBER

Generate the instrument calibration number on the calibration datasheet as INSCALXXYYZZZ where INS denotes instrument, CAL denotes calibration, XX denotes the year, YY denotes month and ZZZ denotes sequence number.

8.0 ABBREVIATIONS

BOD                Biochemical oxygen demand

XYZ                 XYZ Limited

CQA                Corporate Quality Assurance

QA                   Quality Assurance

SOP                Standard Operating Procedure

> Operation and Calibration of Disintegration tester Apparatus

Appendix and Logbook - Download

BANTI SINGH

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