Sterilization process automated systems

The most efficient way to protect the worker is keep him away from all operations, like loading, unloading, and starting procedures during the cycle. So the sterilization process should be automated and computerized. ° Besides the worker protection, the computerized system allows the cycles self-certification, which adds reproducibility advantages to efficiency of the sterilization cycle. 

The utilisation of absolute barrier technology and automated systems to minimise human interventions in processing areas can produce significant advantages in assurance of sterility of manufactured products. When such techniques are used, the recommendations in these Supplementary Guidelines, particularly those relating to air quality and monitoring, still apply, with appropriate interpretation of the terms work station and environment . 

The continuous bioreactor offers more operational control and flexibility over batch bioreactors. Practical production is made simpler and more profitable due to the possibility for automation and the lack of cleaning and sterilization processes (Bellgardt, 2000b). The added equipment cost is offset with operational savings while control schemes, which are limited to a few hundred variables, are often much simpler than the corresponding batch bioreactor systems (Simon et al., 2006 Williams, 2002). 

An automated machine has been developed for sterilization of medical, surgical, and dental instruments. It uses buffered peracetic acid liquid of 0.1-0.5% concentration. Peracetic acid sterilization systems have been adopted for hemodialyzers. The food processing and beverage industries use peracetic acid extensively because the breakdown products in high dilution do not produce objectionable odor, taste, or toxicity. Since rinsing is not necessary in this use, time and money are saved. 

The use of trays during lyophilization is less common, nevertheless, ring trays with removable bottoms are sometimes used to transfer vials to/from the lyophilizer. Where trays are used, they must be cleaned and sterilized prior to each batch. Large lyophilization facilities will sometimes use an automated loading/unloading system in which all shelves or a shelf at a time are processed. Regardless of the practice, ISO 5 conditions are required for all areas of the facility in which partially stoppered containers are transferred or handled. As previously mentioned, it may be possible in some operations to transfer containers in a manner that they are not exposed to the environment during transfer. 

Fig. 9 Two superheated water spray autoclaves with a chamber capacity of approximately 4m, with a rotating load and sliding double doors. The man-machine interface of the process controller is not shown. The automated loading/unloading systems, frequently used with large sterilizers to allow faster loading and unloading operations, are shown instead. (Adapted from Ref.t l.)...

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