Super Heated Water Spray Sterilizer



Super Heated Water Spray Sterilizer

Terminal Sterilization

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.


Super-heated water spray terminal sterilization is an efficient method for achieving sterility with highest assurance of the end product in sealed pharmaceutical containers.
The product is introduced in the sterilizer chamber on appropriate carriages and trays. The chamber bottom is filled with purified water which contains low bio-burden. This water is circulated in a closed loop, utilizing a high quality centrifugal pump. The water passes through an external heat exchanger to reach appropriate sterilization temperature before it is sprayed through perforated distribution plate from the top of the chamber in the cascade form. The elevated flow rate ensures even temperature throughout the chamber during the sterilization process. The water reaches the sterilization temperature quickly. The counter pressure is applied using the sterile filtered air to prevent any damage to plastic container or rubber closures from being displaced from glass bottles. After the sterilization cycle is over, the water is indirectly cooled through the external heat exchanger. The same cooled water remains in circulation resulting in cooling of load in the chamber. The entire sterilization cycle takes approximately 1 hour.



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