Huanyu autoclave provide you autoclave,sterilizer,medical autoclave,water shower sterilizer,pulse vacuum autoclave,steam sterilizer.Huanyu pharmaceutical autoclave equipment is the one of the highest quality manufacturers and suppliers.
You are here: Home » News » Equipment and process requirements during sterilization
Equipment and process requirements during sterilization

In the assessing process requirements, along with the installation area requirements, the following equipment and process requirements also should be considered. For example, temperature probes ports for validation studies, and assign the number of port, size, location and type. Loading and unloading requirements. Door gasket medium requirements, use clean steam or pharmaceutical air as medium. Determine if a backup door gasket is required. Loading configuration such as the sterilization items size, type and number of loads. And achieving sterilization cycle time needed and the requirements of production capacity.
For the sterilization of porous or hard goods such as equipment, tubing and gowns, the effect of air removal is a critical part to allow optimum heat transfer to the load. Air should be removed from the sterilizer chamber and load before the sterilization exposure phase and minimized in the steam supply to the sterilizer. Steam supplied to the sterilizer should be saturated steam and not contain substances that would chemically contaminate the material with which it comes into contact. For the liquid loads, the steam acts principally as an agent for heat transfer. Therefore, compared to porous or hard good loads air removal and steam attributes are not of equal significance. For the terminal sterilization of materials in their final packaging, the major concern is the identification of a sterilization cycle that ensures that sufficient effectiveness of killing has been achieved in all location of the load without compromising item or product. Due to these factors, care must be taken to ensure that the temperature across the load is uniform and that the air over pressure where utilized is sufficient to minimize the breakage or distortion of containers.
Consider the number of cycles to be available for the range of items being sterilized. Include additional cycles to be used with the autoclave such as the leak test of autoclave chamber, vent filter sterilization and the test of air removal. Describe the requirements for the steps or phase that are required for the range of the sterilization cycles to be used. In each phase identify the critical requirements and variables that are needed. For example, in the heat-up phase, including the number of vacuum pulses, the time needed to attain certain vacuum, the vacuum hold time, the vacuum and the size of pressure. In the charge phase, including the rate of charging and the temperature and the rates of pressure ramp. In the phase of sterilization, including the temperature and pressure ranges. In the cool-down phase if required, including evacuation level if vacuum drying is used, hold time, and heat input if drying is accomplished utilizing heat input. In the phase of exhaust, including the rate of exhaust, pulse drying, equalization time, vacuum relief phase if required, liquid cooling temperature and method as well as temperature and pressure ramp rates.

Please enter your message