Pharmacy Courses

Main Tests for Validation of Autoclave in Pharmaceutical Industry

1. Temperature Accuracy Test

This test ensures that the autoclave is able to maintain the desired temperature accurately throughout the sterilization process. It involves placing temperature probes at various locations inside the autoclave and comparing the readings with the set temperature.

2. Pressure Uniformity Test

This test checks if the pressure distribution inside the autoclave is uniform during sterilization. It involves placing pressure sensors at different locations and comparing the readings to ensure there are no significant variations.

3. Biological Indicator Test

This test uses biological indicators (e.g., spore strips) to validate that the autoclave effectively kills microorganisms during sterilization. The indicators are placed inside the autoclave along with a known population of microorganisms and then incubated to check for any surviving organisms.

4. Bowie-Dick Test

This test is specific to pre-vacuum autoclaves and checks for air removal efficiency and steam penetration capability. A Bowie-Dick test pack containing a chemical indicator is placed inside the autoclave, and after running a specific cycle, any color change or pattern deviation indicates inadequate air removal or steam penetration.

5. Leak Test

This test ensures that the autoclave is properly sealed and does not have any leaks. It involves pressurizing the autoclave with air or water and checking for any pressure drop or visible leaks.

6. Cycle Development Test

This test involves running multiple sterilization cycles with different parameters (e.g., temperature, pressure, time) to determine the optimal settings that achieve effective sterilization without compromising product integrity.

Read also:


  • Validation of Steam Sterilization Cycles in Autoclaves" by PDA Technical Report No. 1, Parenteral Drug Association, 2012.
  • Validation of Autoclave for Sterilization Process in Pharmaceutical Industry" by S. S. Patil et al., International Journal of Research in Pharmaceutical Sciences, 2019.
  • Bowie-Dick Type Test for Pre-Vacuum Steam Sterilizers" by ANSI/AAMI ST79:2017, Association for the Advancement of Medical Instrumentation (AAMI), 2017.

Resource Person: Ershad Moradi

Previous Post Next Post