SOP for Bacteriological Incubator : Pharmaceutical Guidelines

SOP for Bacteriological Incubator

Standard operating procedure of bacteriological incubator used to incubate the bacterial cultures.

1.0 OBJECTIVE

To describe the procedure for the calibration of the bacteriological incubator.

2.0 SCOPE

This SOP is applicable for the calibration of the bacteriological incubator.

3.0 RESPONSIBILITY

Microbiologist - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 General cleaning procedure

5.1.1 Ensure that the power supply to the incubator is switched OFF.
5.1.2 De-dust the incubator daily externally with a clean dry cloth.
5.1.3 Once in a week remove adhered dust by wet mopping using soap solution. Afterward, wipe the surface with a clean dry cloth to remove the moisture.
5.1.4 Mop the interior surfaces with a clean dry cloth, daily.

5.2 Operating Procedure

5.2.1 Ensure that the incubator is properly connected to the power supply.
5.2.2 Switch 'ON' the main switch and then the cabinet switch.
5.2.3 Set the required temperature to 37.0 °C by pressing the 'set knob and soft keys.
5.2.4 Monitor the temperature daily as per following procedure.
5.2.5 Temperature shall be recorded which is displayed on LCD of the controller of the incubator.
5.2.6 Observe the temperature shown on the digital display. The temperature should not differ by + 2 °C.
5.2.7 Temperature of incubator having online printer shall be recorded in printout chart.
5.2.8 Take the print out on monthly basis.
5.2.9 If the online recording system is not working properly inform Manager-QC and put 'Out of Order' label.
5.2.10 Once the printer is rectified, a comment shall be written on the printout for the gap period.
5.2.11 Report any discrepancy observed during operation or temperature monitoring to Manager-QC.
5.2.12 Inform to Engineering Department for rectification and put the status label of 'Under Maintenance'.
5.2.13 Maintain the record of incubator usage as per annexure I.
5.2.14 If the online printer is not working satisfactory fill the temperature record as per Annexure II.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure


ANNEXURE - I
BACTERIOLOGICAL INCUBATOR USAGE LOG
INSTRUMENT ID.______________________ TEMP RANGE __________________
Date
Product
B.No.
Plate incubated
Tube incubated
Total No
Time
Removal
Total No
Time
Removal
Date
Time
Date
Time


































Observation
Remarks
Analyst
Checked By













ANNEXURE - II
TEMPERATURE MONITORING RECORD
Date
Temp. at 09.00. hours
Temp. at 17.00. hours
Checked by
Remarks



















Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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