SOP For operation cleaning maintenance and calibration of Hot Incubator used for Bacterial Endotoxin Test

 

SOP for operation, cleaning, maintenance and calibration of hot incubator used for bacterial endotoxin test is described in this post which you can follow in the section of microbiological lab.

Objective:

This procedure has been established for operation, cleaning, maintenance and calibration of hot incubator used for bacterial endotoxin test. 

Scope:   

This procedure is applicable to microbiology lab.

Responsibility:                          

Microbiologist.                             

Accountability:

Quality Control Manager.            

Procedure:

Connect the power supply and Switch "ON" the incubator. 

Set the temperature at 37°C ± 1°C of the incubator by pressing up and down arrows buttons given on the front side of equipment.

Finally check the required temperature on PLC screen and the heater will start. 

After maintaining the required temperature the heater gets automatically “OFF”.  

Observe again after 30 minutes of acquiring the set temperature. If the displayed temperature is stable at the set temperature, then the equipment is ready for use. 

Cleaning: 

 Clean the inner and outer surfaces of the incubator with a lint-free cloth.

Frequency: Weekly

Maintenance:

Switch "OFF" the equipment and paste a label "UNDER MAINTENANCE"

Calibration:

External Calibration Frequency: once in a year and performed externally by third party.

Internal Calibration Frequency: Twice a year performed by microbiologist.

Internal Calibration 

Operate the equipment as per SOP.

Place  at least 100ml of water for injection (WFI) at five different locations along with a calibrated thermometer.  

Set the incubator at 37°C  and after acquiring required temperature, note down the temperature atleast for 1hr at the interval of 02 mints.

After compilation of data find out temperature uniformity throughout 1hr period. It should be ± 1°C. 

After calibration, immediately put the “CALIBRATED” tag duly signed by microbiologist and quality control manager