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.
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.
- Sterilization of filled containers of HDPE/LDPE bottles, PVC multi-layer pouches or glass bottles.
- Terminal sterilization of large volume infusion solution in glass bottles, plastic bags.
- High flow circulation centrifugal pumps
- Plate type heat exchanger for efficient heating and cooling of water.
- Special distribution plate arrangement for optimal water shower
- Installation is floor or pit mounted
- Optional automatic loading – unloading system
- Single or double door, semi-automatic hinged type or automatic sliding type
- Water distribution headers & spray nozzles arranged in a manner to ensure uniform heat distribution throughout load
- Temperature & pressure monitoring inside the chamber
- PLC & HMI based control system with provision for SCADA connectivity.
- Range of alarms & safety devices for product, process & operator safety
- Strip chart or paperless recorders available
- High powered centrifugal pump used for re-circulation of water in the system
- All international brands piping and valves used to exemplify the performance of the machine (optional)
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