Post on 14-Apr-2018
7/30/2019 VALIDATION OF INCUBATORS.doc
1/4
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.
7/30/2019 VALIDATION OF INCUBATORS.doc
2/4
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
7/30/2019 VALIDATION OF INCUBATORS.doc
3/4
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
7/30/2019 VALIDATION OF INCUBATORS.doc
4/4
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
0 COMMENTS:
http://pharmaceuticalsops.blogspot.com/2011/01/validation-of-incubators.htmlhttp://pharmaceuticalsops.blogspot.com/search/label/VALIDATION%20OF%20INCUBATORShttp://www.blogger.com/post-edit.g?blogID=647491574162861344&postID=6928900405023891919http://pharmaceuticalsops.blogspot.com/2011/01/validation-of-incubators.htmlhttp://pharmaceuticalsops.blogspot.com/search/label/VALIDATION%20OF%20INCUBATORS