What is an Autoclave and its importance?
An autoclave is a device that sterilizes different items and pharma products using steam. The steam is applied under high pressure, generating high temperatures. High temperatures and pressure effectively eliminate harmful bacteria and microorganisms. Relative to temperature, pressure is also necessary as a part of sterilization requirements, which facilitates achieving the desired temperature.
The sterilization temperature is pre-defined and is set after thorough study and validation by the quality department, and it is necessary to keep this temperature. Otherwise, the sterilization will become ineffective, and the items will still contain harmful bacteria and microorganisms.
The typical steam temperature is 121°C for about 30 mins at 15 psi of steam pressure.
The sterilization occurs in a three-phase cycle, each with definite application, and includes the following.
Pre-Vacuum Cycle - in this cycle, the air is removed from the chamber to create a vacuum inside it. It removes air pockets for easy steam flow inside the chamber. This cycle is applied more than once, typically three types
Sterilization Cycle: In this cycle, steam is applied to the chamber to achieve the desired temperature. In addition to temperature, pressure is also maintained for a pre-defined value. Temperature is kept for a specified time, and after the timer has elapsed, the temperature is decreased to end the sterilization process.
Post - Vacuum Cycle - in this cycle, steam is removed from the chamber to cool it, and items can be easily removed.
After completion of the post-vacuum cycle, the chamber door is opened to empty the chamber for further process. ,
Autoclaves also consist of instrumentation critical to the equipment's safety and process performance, such as temperature and pressure.
Temperature is used to monitor chamber temperature and serves two purposes,
Ensure accurate sterilization temperature throughout the process and prevent deviation from these values. This is ensured using a controller that continuously monitors and compares the temperature sensor value with the set value. If there is a deviation, it adjusts it by opening or closing the steam valve.
Prevent damage to the autoclave due to overtemperature. This is achieved by using a central controller that continuously monitors the temperature sensor, and if it exceeds the safe threshold value, it immediately halts the process.
The pressure sensor monitors the steam pressure inside the chamber and adjusts the pressure according to the set value. Additionally, if chamber pressure becomes abnormally high due to any malfunction, it also sends a signal to abort the process to prevent damage to the autoclave.
Like other pharma equipment, a central controller operates the autoclave and other automation components, such as the machine Interface, Sensor, and valves.
At the end of the cycle, a recording device records all the critical parameters, such as temperature and time. This is necessary to ensure the process's integrity and to present it to the regulations during their routine inspection.
Some considerations to look for when selecting an Autclave
Laboratory scale vs. commercial scale
Considering the scale of operation is the first step when selecting an autoclave. Like many other pharma equipment autoclaves are also used in Quality labs and R&D sections of pharma organizations with different specifications from commercial ones. However, their application and work remain the same.
Laboratory-scale autoclaves have much smaller chamber sizes and the resulting autoclave capacity.
In addition, there are multiple chamber loading and off-loading profiles, such as front-loading and top-loading. Its selection depends on the item types.
◆ Top loading is preferred for liquid or glassware loads
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