sop for validation of incubators
1.0 OBJECTIVE
To lay down a procedure for validation of incubator in microbiology laboratory.
2.0 RESPONSIBILTY
Microbiologist / Executive.
3.0 ACCOUNTABILITY
Quality Assurance Manager
4.0 PROCEDURE
4.1 Details of the Standard thermometer used for validation of Lab thermometer.
4.2 Type : Liquid – Glass lab Thermometer.
4.3 Place the standard thermometer dipped in glycerin in incubator at various locations as mentioned
4.4 The incubator is set for desired temperature with the knob on control panel of incubator
` e.g 32.5 0C, 35 0C & 22.5 0C.
4.5 Wait till the temperature reaches at set point & note down the temp. displayed on the small screen of incubator and compare this temp.
with standard thermometer kept near the RTD probe.Likewise check the temperature after every 15 minutes up to one hour and note down the readings on the format.
4.6 Record any difference between the displayed temp. & temp. showed by standard thermometer and set the incubator accordingly
4.7 Frequency of validation : once in a year.
4.8 The observations are noted in the format of annexure-I
5.0 PROCEDURE FOR VALIDATION OF D.H.S (HOT AIR OVEN):
5.1. : Keep all the apparatus wrapped thrice with aluminum foil inside DHS as locations shown
in the diagram.
5.2 : Keep the Spore loaded strips (having spore of B subilis) & Endotoxin indicator indicators
having 10,000EU/vial in DHS(hot air oven) kept in 30ml vial wrapped thrice with aluminum foil at locations shown in the diagram keep one vial unbaked as PPC.
5.3 : Set the hot air oven at 250C ,wait till the temperature reaches upto the set
temperature.
5.2 : After reaching the set temperature, note the time & temperature, hold for one hour
5.4 : After completion of depyrogenation cycle, switch off the power supply and take out
indicators for testing.
5.5 : Procedure for testing reduction of endotoxin as under.
5.5.1 : Take out the baked endotoxin loaded vial from the DHS.
5.5.2 : Reconstitute 1ml of LRW in the baked vial and transfer 100l of sample to the
depyrogenated reaction tube kept in heating block at 370 C and add 100l of LAL in the
same tube in duplicate.
5.5.3 : Prepare the dilutions for PPC for confirming 10,000EU/vial .
5.5.3 : Note the gel clot after incubation of one hour
5.6 : Procedure for testing of reduction of prepared spore loaded strip(B subtilis):
5.6.1 : Transfer (spore loaded) strip from backed vials and are inoculated in100ml sterile SCD
media and incubate at 30 – 350C for 7 days to observe for any turbidity, if any, report to Manager QC..
6.0 : REFERENCE & ANNEXURE
USP 25
