Validation of Sterilization Process in Autoclave
Validation of Sterilization Process in Autoclave (Loaded chamber)
Purpose : To provide the procedures to be followed for study of heat distribution studies in loaded chamber of Autoclave.
Scope : This procedure is applies to all Autoclaves used to sterilize Containers or Equipment’s used for aseptic processing of sterile Products
This procedure will be implemented under the following conditions.
- Prior to initial use of new autoclave.
- Any process change which might affect capability of sterilization.
- Any repairs or maintenance of utility line supplied to autoclave.
Responsibility : Quality Assurance Manager and Maintenance Manager.
Equipment Identification :
- Equipment Type : Steam Sterilizer.
- Make of equipment : Lance Engineering.
- Model of equipment : 10/90
- Equipment code : A-1
- Size : 1050 x 1200 x 2100 mm
- Equipment location : Sterilization section.
Equipment’s / materials required :
1)Loading trolley .
2) Biological Indicator (Bacillus sterothermophilus)
3) Incubator .
4) Signaloc Indicator.
5) Chemical Indicator (Benzoic acid ampoule)
Validation parameters :
1) Sterilization Temperature : 121°c
2) Sterilization pressure : 1.4 kg / cm
3) Sterilization Time : 30 minutes
Autoclave loading pattern :
1)Clean the chamber with lint free cloth .
2) Place the Biological Indicator on each rack of trolley according this arrangement so that whole volume of chamber is covered
(a) 4 on front side of trolley.
(b) 4 on right side of trolley.
(c) 4 on left side of trolley.
(d) 1 on middle of trolley.
3) Place Signaloc Indicator and Chemical Indicator on the same place where Biological Indicator are placed.
4) Close the Autoclave chamber properly & lock it.
5) Place the new graph on recorder.
6) Check the line valve of steam for proper steam supply.
7) Start the autoclaving cycle as per S.O.P
8) Watch the chamber temperature and pressure carefully & note down the following parameters.
Autoclave start Time :
Time at which temperature & pressure achieved :
9) Allow the run Autoclave for 30 minutes & note down the temperature & pressure after every five minute in observation table.
10) After the 30 minutes switch off the autoclave by closing the steam valve & note down the time.
Time at which Autoclave switch off :
11) Allow the chamber to cool down.
12) Remove all the Signaloc Indicator & Chemical Indicator, check the colour of Sigaloc Indicator as per standard , Chemical Indicator should be melt in side of ampoules.
13) Check the thermograph of temperature recorder.
14) Collect the all Biological Indicators carefully collect the spores of Biological Indicators with media and incubate them at 55 +/- 2°c for 7 day, simultaneously incubate two unautoclave Biological Indicator same as above process.
15) Observe all the Indicators on daily basis for presence or absence of growth and record in observation table.
Date of incubation :
Date of final observation :
Result : (a) Biological Indicator result
1) Positive control is showing growth /no growth on……………………. Day of incubation .
2) Growth is observed on following location number ……..
3) No growth is observed on location No…………..
(b) Temperature recorded from temperature recorder device from…….to………
(c) Jacket pressure recorded from dial gauge from…… to ……
(d) Chamber pressure recorded from dial gauge from……to……
- Sterilization cycle recorded on thermograph is normal / abnormal.
Enclosed the following report:
- Observation table for Biological Indicators
- Observation table for temperature display & pressure display.
Name of organism : Bacillus Sterothermophilus.
Incubation temperature : 55 +/- 2°c
Incubation period : 7 day
Sterilization cycle details
Date of sterilization :
Load of chamber :
Sterilization temperature 121°c achieved at :
Sterilization started on :
Jacket pressure :
Chamber pressure :
Hold time/ Sterilization time :
Sterilization completed at :
Any abnormality observed during cycle:
|S. No.||Date||Time||Jacket pressure||Chamber
OBSERVATION TABLE FOR BIOLOGICAL INDICATORS
Date of incubation :
Final observation :
Validation study conducted by :
- Quality assurance Department:
- Quality control Department:
- Production Department:
- Maintenance Department:
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube