Super Heated Water Spray Sterilizer
Certain products need to be sterilized in its final container as this permits the measurement and evaluation of quantifiable microbial lethality. This is called terminal sterilization. Terminally sterilized products are treated in a microbially lethal process and hence represent the lowest risk category of sterile pharmaceutical products unlike products aseptically manufactured in a microbiologically controlled environment.
Us Pharmacopeia Guidelines
Terminally sterilized products must have a probability of non-sterility (PNS) of not more than one in a million units produced. This is often stated as PNS of 106, or the probability of product bio-burden surviving the sterilization process in any single unit of product is less than one in one million. The proof that a terminally sterilized product complies with the 10×6 PNS can be accomplished by several different sterilization cycle development approaches. The proper application of this method requires extensive scientific knowledge regarding the sterilization method selected for use with a specific product.