Sterility viable life forms

Sterility is defined as the total absence of all viable life forms. Parenteral products and ophthalmic products are expected to be sterile. Parenteral products must be sterile because their route of administration overrides the body s external physical barriers to infection. Ophthalmic products must be sterile because eye damage is often irreparable. No distinction can be made between microorganisms that are known to be specific causative agents of disease and those that are not. 

Sterility has an absolute definition (absence of ALL viable life forms). As with all absolutes, it is difficult, if not impossible, to prove. 

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... 

Sterility is defined as the total absence of viable life-forms (Table 1). The concept of sterility is absolute and acknowledges no boundaries. However, life-forms are ubiquitous on this earth, and sterile conditions can only exist within some form of boundary. Once these boundaries are broken down the sterile condition is inevitably lost. 

In summary, there is always a finite probability of a survivor occurring, no matter the strength or duration of a sterilization process. In other words, absolute sterility, in the sense of total freedom from all viable life forms, can never be achieved in practice. The acceptance of exponential inactivation lunetics has led to two different approaches to the establishment of standards of satisfactory sterilization treatment, the inactivation factor approach and the sterility assurance level (SAL) approach. 

Bioburden is a jargon word that can assume at least two different meanings. As a determinant of sterility (Vq) it means each and every viable life-form contaminating the product item. As a practical concept it usually means an estimate of the numbers of microorganisms contaminating a product item, subject to all the... 

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