Skip Navigation Links.
Collapse Knowledge BaseKnowledge Base
Expand Validation ApproachValidation Approach
Expand RegulationsRegulations
Expand Periodic AssessmentPeriodic Assessment
Expand Risk AnalysisRisk Analysis
Expand Facilities and HVAC SystemFacilities and HVAC System
Collapse Equipment ValidationEquipment Validation
Expand Analytical Instruments (AI)Analytical Instruments (AI)
Expand SterilizationSterilization
Expand Depyrogenation and EndotoxinsDepyrogenation and Endotoxins
Expand Utility SystemsUtility Systems
Expand Packaging and Shipping ValidationPackaging and Shipping Validation
Expand Cleaning Validation / Efficacy StudyCleaning Validation / Efficacy Study
Expand Computerized SystemsComputerized Systems
Expand Process ValidationProcess Validation

Moist Heat (Steam) Sterilization - Autoclaving

Steam sterilization, also known as autoclaving, is a widely used method of sterilization that utilizes steam under high pressure to kill or inactivate microorganisms on objects or surfaces. It is one of the most effective and efficient methods of sterilization, capable of achieving high levels of microbial reduction.

Moist Heat (Steam) Sterilization - Autoclaving

Steam sterilization typically consists of the following phases:

  1. Pre-conditioning: In this phase, the sterilization chamber and the load are prepared for sterilization. The chamber is preheated, and the load is properly arranged and positioned to allow steam penetration.
  2. Exposure: Once the pre-conditioning phase is complete, steam is introduced into the chamber to achieve the desired sterilization temperature. The load is exposed to the steam for a specified period to ensure sufficient heat transfer and microbial inactivation.
  3. Holding: After the exposure phase, the sterilization temperature is maintained for a predetermined holding time. This holding time allows for complete and uniform heat penetration throughout the load, ensuring effective sterilization.
  4. Exhaust: Once the holding time is complete, the steam is gradually removed from the chamber through exhaust vents. This phase helps to release excess moisture and steam pressure, preparing the load for safe removal.
  5. Drying: After the exhaust phase, the drying phase begins. It involves removing residual moisture from the load and the chamber. This step is crucial to prevent moisture-related issues, such as product degradation or the growth of microorganisms.

It's important to note that the specific details of each phase may vary depending on the sterilizer equipment and the nature of the load being sterilized. The sterilization process should be carefully designed, monitored, and validated to ensure the effective elimination of microbial contaminants and the maintenance of product sterility.

Steam sterilization is effective in destroying microorganisms by denaturing proteins and disrupting the cellular structures of microorganisms. The high temperature and pressure of the steam ensure the complete inactivation of microorganisms, including bacteria, viruses, and spores.

Validation studies and regular monitoring should be conducted to ensure the effectiveness of the steam sterilization process. Biological indicators, such as spore strips, can be used to confirm the efficacy of sterilization. Proper maintenance and calibration of autoclaves are also essential to ensure accurate temperature and pressure control.

It is important to follow validated procedures, manufacturer's instructions, and regulatory guidelines when performing steam sterilization to ensure the safety and efficacy of the process.