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Pre-vacuum process sterilization

Pre-vacuum process means that a sterilization process in which air is removed from the steam sterilizer chamber using a vacuum pump or other mechanical system before the exposure phase begins. This method is particularly suited to load items that can trap such tubing, filters and filling machine assemblies and so on. In other words, In the pre-vacuum process, using a mechanical pump or steam educator evacuate air from the autoclave chamber before the sterilization portion of the cycle begins. The educator means that a device that produces vacuum by means of the Venturi effect. This method is suited to load items with internal volumes, such as tubing, filters, wrapped packs as well as fill assemblies and so on. Load items have many different forms. A porous and hard goods load consists of items in which the bio-burden is inactivated through direct contact with saturated steam. Porous and hard goods loads items means that items likely to contain air. For example, filters, stopper’s, hoses, garments, cleaning equipment, or machine change pares. Add three other definitions related to load. Load zone means that area within the autoclave chamber where materials to be sterilized may be placed. The maximum load means that the maximum quality or mass of items in a sterilizer load. And the minimum load means that the minimum quality of mass of items permitted in a sterilizer load, the minimum load may consist of items that are the greatest heat-up and air removal challenge.

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The steam pulses serve to rapidly fill the voids created by the vacuum pulses, which cause incremental decreases in the amount of residual air. Large pressure differentials between the steam and vacuum pulses increase the air removal. The number of pulses required should be determined at the beginning of cycle development. Alternating steam vacuum pulses are more effective for air removal than a single deep vacuum, and that will ordinarily result in either shorter cycle times or less residual air in the autoclave chamber. They allow to use a smaller and less expensive vacuum pump. Vacuum pulsing cycles are used frequently in the pharmaceutical business to sterilize some loads that contain items from which air removal can be difficult. The greater the differential pressure between the steam pulse and vacuum levels, the greater the amount of air removal. Such load items include coiled hoses, filter cartridges and housings, densely packed containers of stoppers and packages of clean room garments. Vacuum may take the place of liquids in unsealing containers, so the use of vacuum pulses should have a risk assessment.
Besides risk assessment, the validation is also very important. The validation means that a documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria. The proof of validation is obtained through rational experimental design and the evaluation of data, preferably beginning from the process development phase and continuing through the commercial production phase.

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