The Importance of the Autoclave

It is a day of many surgeries in a hospital and the surgical team was slowed down because the autoclave failed during one of the cleaning processes between surgeries. Some scheduled surgeries have to be pushed out the next day. It does not sound good, right? The purpose of an autoclave in accredited facilities, cleanrooms, educational establishments, pharmaceutical research, and accredited laboratories as well as manufacturing is singularly that of destroying any micro-organisms in a load. The overall objective is achieved through sterilization, which is designed to render items safe, ready for subsequent disposal or re-use.

Most accredited facilities have autoclaves. This is because steam can clean many common medical devices, and it is typically the safest and cheapest option. Some technicians will only consider using another method when the medical device is made of a heat-sensitive material or cannot be steam sterilized. The autoclave applies intense pressure and heat to destroy all microorganisms on an object. After all, one of the most important benefits of autoclave sterilization is that it requires considerably less time and heat than a dry heat sterilizer, due to steam’s capacity to transfer energy. Using autoclaves for steam sterilization has become the new standard for hospital equipment decontamination and is required for accredited laboratories.

With such importance placed on the autoclave how can the user be certain that it has achieved the required sterilization? Improperly autoclaved materials result in contamination, lost time and wasted money – and much worse in extreme circumstances. The necessity of qualifying an autoclave and validating the sterilization process arises from various laws and regulations, included the current Good Laboratory Practices (cGLPs). Although the terms qualification and validation are usually mentioned in one sentence or even used synonymously, different statements and approaches are hidden behind them. The common denominator of both concepts is that documents conforming to the guidelines, which contain the definition of the individual tests and the documentation of the test results, must be prepared. Accredited facilities should have written qualification/validation plan that includes protocols that are used to document the test results during implementation and meet cGLPs requirements.

• Qualification: In the context of a system qualification, proof must be provided that a system with the technology used is suitable for the intended task, works perfectly, and delivers results that meet the requirements.

• Validation: The objective of process validation is to prove that the process is effective and can deliver a product (result) that is reproducible and meets the required quality requirements.

Importance of Autoclave Preventive Maintenance

Autoclave preventive maintenance must meet current good laboratory practices and ensure that the device operates efficiently, achieves sterility, and decontaminates the load. Accredited laboratories should follow the cGLPs recommended daily, weekly, and monthly cleaning protocols and be carried out by healthcare technicians and staff as per manufacturer’s instructions. However, annual maintenance should be done by qualified maintenance engineers who will inspect, clean, and calibrate the equipment. This should be within the current Good Laboratory Practices.