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.                  

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 250°C ,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 100ml of sample to the

depyrogenated reaction tube kept in heating block at 37⁰ C and add 100ml  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 SCD

media 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 & Assistants 

Period  --         One day

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						DISPLAYED TEMP.	MINIMUM	MAXIMUM	DEVIATION
	LOCATIONS INSIDE THE CHAMBER									+	-
	1	2	3	4	5	6
INITIAL TEMP	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C
AFTER 15 MIN	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C
AFTER 30 MIN	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C
AFTER 45 MIN	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C
AFTER 60 MIN	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C	°C

             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