VALIDATION OF STEAM STERILIZATION/ AUTOCALVATION

1. PURPOSE

1.1 To establish the system for Validation of Moist heat Sterilization.

2. SCOPE

2.1 It is applicable for Injectables Department.

3. RESPONSIBILITY

3.1 Quality Control Manager
3.2 Microbiologist
3.3 Production Officer (concerned)
4. PROCEDURE

1. VALIDATION BY AUTOCLAVE TAPE

Autoclave tape is affixed to all trolleys and Effectiveness of Autoclavation is determined by the change in color of the tape.

2. VALIDATION BY BIOLOGICAL INDICATOR METHOD.

Prepare the media as directed on the label.

1. Fluid Thioglycollate Medium ( For Bacteria )
2. Tryptic Soy Broth ( For Fungi )

Sterilize in an autoclave and incubate at required temperatures for at least 24 hours.

Inoculate the Fluid Thioglycollate Medium with Staphylococcus aureus and Tryptic Soy Broth, with Candida Albicans.
Keep one portion of each of the un-inoculated media un-opened ( Medium Control.)
Keep one portion of each of the inoculated media, un-opened. ( Culture Control.)
Place the Rest of the Inoculated tubes at different position in the Autoclave chamber, with the product undergoing process of Autoclavation.
After completion of the process incubate the media at their respective temperature.
Fluid Thioglycollate Medium ( For Bacteria ) at 30 – 35º C
Tryptic Soy Broth ( For Fungi ) at 20 – 25º C
Incubate the samples and controls for 14 days and observe.

INTERPRETATION OF RESULTS:
Media Control: Must NOT show any growth to ensure the sterilization of media.
Culture Control: Must show the growth to ensure the growth promoting activity of the media.
Test Samples: NO GROWTH VALIDATES THE PROCESS OF STEAM STERILIZATION / AUTOCLAVATION.

3. TEMPERATURE VALIDATION BY CALIBRATED THERMOCOUPLES.

Thermocouples are used for the temperature validation of autoclave, which are calibrated before use in autoclave temperature validation.
Calibrated thermocouples are placed at 18 different specified locations in the autoclave to have true picture of temperature conditions inside the autoclave. They are placed at front, middle, end, top, centre and bottom of the autoclave.
INTERPRETATION OF RESULTS:
Thermocouples should not show temperature deviation by + 0.5°C, as compared to actual panel temperature of autoclave.
Hence process is validated.
5. Frequency / Year

Validation of Moist heat Sterilization should be conducted Once in a Year.