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 in order to ensure smooth operation and its use monitored to obtain consistent and reproducible results and minimize downtime and meet regulatory requirements.
RESPONSIBILITY AND Accountability
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.
PROCEDURE
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/trice in a week.
5.2.2 Open
the door only at the time of requirement, do not open 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 Instrument is off).
5.3.3 Set 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 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.
6.0 CALIBRATION
6.0.1 Calibration Frequency: Quarterly
6.0.2 Calibrated Platinum
resistance thermometer (PRT) with sensor and digital temperature indicator
Apparatus are 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 operation and calibration of instrument
to 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 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
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
