Validation of Sterilization Process in Autoclave

Validation of Sterilization Process in Autoclave

VALIDATION PROTOCOL     

Validation of Sterilization  Process in Autoclave (Loaded chamber) 

Purpose: To provide the procedures to be followed for study of heat distribution studies in the loaded chamber of Autoclave.

 Scope:  This procedure is applied to all Autoclaves used to sterilize Containers or Equipment used for the aseptic processing of sterile  Products

This procedure will be implemented under the following conditions.

Before the initial use of the new autoclave.

Any process change that might affect the 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 / materials required :  

1)Loading trolley.

2) Biological Indicator (Bacillus sterothermophilus)

3) Incubator.

4) Signaloc Indicator.

5) Chemical Indicator (Benzoic acid ampoule)

6) Thermograph. 

Validation parameters :

1)  Sterilization Temperature:121°c

2)  Sterilization pressure: 1.4 kg/cm

3) Sterilization Time:30 minutes

Autoclave loading pattern :  

Procedure :

1)Clean the chamber with a lint-free cloth.

2) Place the Biological Indicator on each rack of trolley according to this arrangement so that the whole volume of the chamber is covered

(a)  4 on the front side of the trolley.

(b) 4 on the right side of the trolley.

(c) 4 on the left side of the trolley.

(d) 1 on the middle of the trolley.

3) Place the Signaloc Indicator and Chemical Indicator in the same place where the Biological Indicators are placed.

4) Close the Autoclave chamber properly & lock it.

5) Place the new graph on the 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 minutes in the observation table.

10) After 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, and check the colour of the Sigaloc Indicator as per standard, Chemical Indicator should be melting on the side of the ampoules.

13) Check the thermograph of the temperature recorder.

14) Collect all Biological Indicators carefully collect the spores of  Biological Indicators with media and incubate them at 55 +/- 2°c for  7 days, simultaneously incubating two un autoclave Biological Indicators same as the above process.

15) Observe all the Indicators daily for the presence or absence of growth and record in the 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 the 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……

The sterilization cycle recorded on the thermograph is normal/abnormal.

Interpretation :

Enclosed is the following report:

Observation Table for Biological Indicators

Observation table for temperature display & pressure display.

Biological Indicators

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 the cycle:

OBSERVATION TABLE

S. No./Date/Time/Jacket pressure/Chamber pressure/Chamber/temperature/Remarks

OBSERVATION TABLE  FOR BIOLOGICAL INDICATORS 

Date of incubation :

Final observation :

S.No./Date/Incubator/Control (+ve & -ve) /Sign.

A validation study conducted by :

  1. Quality Assurance Department:
  2. Quality Control Department:
  3. Production Department:
  4. Maintenance Department:

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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

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