Sterilization requires conditions

A product to be labelled sterile must be flee of viable microoiganisms. To achieve this, the product, or its ingredients, must undergo a sterilization process of sufficient microbiocidal capacity to ensure a minimum level of sterihty assurance (Chapter 20). It is essential that the required conditions for sterihzation be achieved and maintained through every operation of the sterilizer. 

A door locking system that corresponds to sterile room conditions and that also fulfills all safety requirements should be taken into account. 

Sterilization. Sterility Is a necessary requirement for all membrane devices used clinically, and the sterilization procedure must not change the functional or blocompatlble character of the device. Sterility, the condition of absolute absence of viable life forms, can be achieved by physical (heat. Irradiation) or chemical means. Chemicals used to sterilize membrane devices may be either gaseous (ethylene oxide) or liquid (formaldehyde, peroxides, hypochlorite) In nature. The generally accepted... 

Sterilization procedures must be established so that all parts of the load to be sterilized are submitted to the required conditions of sterilization. 

Sterilization requires appropriate conditions of humidity, gas concentration, temperature and time. 

Correct sterilization requires that the materials and products are completely subjected to the conditions of the respective process. For this purpose, the process used must be validated with consideration of the type of lot. This validation must be repeated by a specified schedule and must also be performed whenever significant equipment modifications are made. 

Safe condition at the time of delivery by the seller will, however, include proper packaging, necessary sterilization, and other precautions required to permit the product to remain safe for a normal length of time... 

Monitoring by Electromechanical Instrumentation. According to basic engineering principles, no process can be conducted safely and effectively unless instantaneous information is available about its conditions. AH sterilizers are equipped with gauges, sensors (qv), and timers for the measurement of the various critical process parameters. More and more sterilizers are equipped with computerized control to eliminate the possibiUty of human error. However, electromechanical instmmentation is subject to random breakdowns or drifts from caUbrated settings and requires regular preventive maintenance procedures. 

Processing in Hquid sterilants results in wet products which require highly specialized packaging. Therefore, Hquid sterilization should only be considered if the sterilized article is to be used almost immediately. Liquid sterilants or their residues can be harmful to living tissues. Therefore it is always necessary to rinse articles with sterile water or saline solution foUowing treatment. Whereas Hquid sterilization is an extremely useful method for articles that caimot withstand the conditions of steam sterilization, the problems associated with its use limit its appHcation. 

Production and service provision - Operate production and service provision under controlled conditions, maintain batch records, validation processes that cannct be verified, maintain identification and traceability of materials, address specific requirements for sterile products, provide suitable conditions for storage and distribution... 

All disinfection and sterilization processes for equipment should be validated, for preference using a microbiological challenge with an organism of appropriate resistance to the disinfectant, sterilant or sterilizing conditions. Once the required log reduction of the challenge organism has been achieved, physical and/or chemical parameters can be set which form the critical control points for the process. 

Organisms are more resistant to ethylene oxide treatment in a dried state, as are those protected from the gas by inclusion in crystalline or dried organic deposits. Thus, a further condition to be satisfied in ethylene oxide sterilization is attainment of a minimum level of moisture in the immediate product environment. This requires a sterilizer humidity of 30-70% and frequently a preconditioning of the load at relative humidities of greater than 50%. 

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