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VALIDATION OF INCUBATORS

1.0 OBJECTIVE

To lay down a procedure for validation of incubator in

microbiology laboratory.

2.0 RESPONSIILTY

Microbiologist / Executive.

3.0 ACCOUNTABILITY

Quality Assurance Control

4.0 PROCEDURE

4.1 DETAILS OF THE STANDARD THERMOMETER USED FOR

VALIDATION OF LAB THERMOMETER.

4.1.1 Type : Liquid - Glass lab Thermometer.

4.1.2 Place the standard thermometer dipped in glycerin in incubator at

various locations as mentioned in annexure-II.

4.1.3 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.

4.1.4 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.

4.1.5 Record any difference between the displayed temp. & temp. showed

by standard thermometer and set the incubator accordingly

4.1.6 Frequency of validation : once in a year.4.1.7 The observations are noted in the format of annexure-I

4.2 PROCEDURE FOR VALIDATION OF D.H.S (HOT AIR

OVEN):

4.2.1 Keep all the apparatus wrapped thrice with aluminum

foil inside DHS as locations shown

in the diagram.

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4.2.2 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. Set the hot air oven at 250C ,wait till the

temperature reaches upto the set temperature.

4.2.3 After reaching the set temperature, note the time & temperature,

hold for one hour

4.2.4 After completion of depyrogenation cycle ,switch off the

power supply and take out

Indicators for testing.

4.3 Procedure for testing reduction of endotoxin as under.

4.3.1 Take out the baked endotoxin loaded vial from the DHS.

4.3.2 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.4.3.3 Prepare the dilutions for PPC for confirming

10,000EU/vial .

4.3.4 Note the gel clot after incubation of one hour

4.4. Procedure for testing of reduction of prepared spore

loaded strip(B subtilis):

4.4.1 Transfer (spore loaded) strip from backed vials and are

inoculated in100ml sterile SCDmedia and incubate at 30 350C for 7 days to observe for any

turbidity, if any, report to Manager QC..

5.0 REASON FOR REVISION

Harmonization of format.

6.0 TRAINING:

Trainer - Head Quality Control

Trainees-- Quality Control Chemists & AssistantsPeriod -- One day

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7.0 DISTRIBUTION:

Certified Copy No. 1 : Head of Department Quality Control

Original Copy : Head QUALITY ASSURANCE.

8.0 ANNEXURES:

Annexure 1. Formats for Instrument validation.

9.0 REFERENCES:

USP 25 page no.-1890 & 2251

ANNEXURE-1

INSTRUMENT VALIDATION

. LOCATION Microbiology

laboratory

NAME OF

INSTRUMENT

Incubator

MANUFACTURED

BY

MODEL No.

IDENTIFICATION

No.

INSTALLED ON

SET TEMPERATURE = C

TIME TEMP. RECORDED DISPLAY

ED TEMP.

MINIMUMMAXIMUMDEVIATION

LOCATIONS INSIDE

THE CHAMBER

+ -

1 2 3 4 5 6

INITI

AL

TEMP

C C C C C C C

C C

C C

AFTE

R 15

MIN

C C C C C C C

C C

C C

AFTE

R 30

MIN

C C C C C C C

C C

C C

AFTE

R 45

MIN

C C C C C C C

C C

C C

AFTE

R 60 C C C C C C CC C

C C

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MIN

LIMIT:- 2% of Set Temperature

CONCLUSION: The incubator is maintaining / does not maintaining set

temperature within

Specified limits.

VALIDATED BY:

CHECKED BY:

DATE:

DATE:

NEXT VALIDATION

MANAGER /QC

DUE ON DATE

Posted by Niazi at11:13 PMLabels: VALIDATION OF INCUBATORS

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