TABLE OF CONTENTS One of the greatest concerns in sterilisation processes and qualification/validation is assurance that the product or item being sterilised is sterile. To fully appreciate the role that statistics plays in sterility assurance, let us start from scratch and begin with the word, sterile.
Sterile is defined as the complete freedom from all living or reproducing organisms or entities. The term implies an all or nothing condition. Either all micro-organisms are killed or removed or they are not. There is a tendency at times, to mistakenly use sterile in the wrong context. For example, in early medical practice sterile meant to destroy only disease organisms. In the home, baby bottles that were boiled were considered sterile.
Sterilisation must be differentiated from lesser ways of destroying or removing microbes. Terms and techniques such as disinfection, sanitisation, pasteurisation, and clean are not synonyms of sterile and to use them or apply them as such only leads to the abuse and misunderstanding of sterilisation. So when the House of Representative was sanitised with chlorine dioxide to eliminate Bacillus anthracis (anthrax), it was not intended to mean sterilisation or complete inactivation of all microbes or terrorist biological agents.
If it were sterile, it would not compromise the safety and health of inhabitants, users, or other persons passing by; it would be free not only from Bacillus anthracis, but freed from all micro-organisms.
To determine sterility it must be tested for, and one must know what sterile means.
Sterile...
