Fully Jacketed 316L Chamber Large Steam Sterilizer With Super Heat Water Spray
Features:
Highly polished mirror finish chambers
Meets and exceeds FDA cGMP’s
316L stainless steel sanitary piping
Piping sloped to drain with no dead legs
Sanitary valves and components
Extensive Validation documentation
Chamber doors secured on four sides
Solid stainless steel door—no welding
Lubricant-free door gaskets
Horizontal sliding doors that are precision machined operate with exceptional smoothness
while providing a safer environment for the operator.
Door gaskets operate without the need for lubrication allowing for less maintenance and
longer life span.
The chamber jacket design utilizes a unique plate and beam construction that provides for
a complete envelop around the chamber.
PLC-based control systems are intuitive, easily understood and operated, while providing
the sophistication for maximum flexibility and ease in validation.
Technical of process control
The process begins with filling the chamber to a predetermined level with purified water.
The water is circulated by the pump through an external heat exchanger that is heated by
plant steam.
The water is then sprayed onto the product as the temperature rises.
Due to the efficient heat transfer, the product is heated rapidly.
Compressed air at an over-pressure is injected into the chamber to compensate for the rising
temperature and pressure that builds inside liquid containers when heated.
At the end of the exposure step, cooling begins.
The circulating water is cooled by an external heat exchanger that is cooled with cooling or
chilled water.
The product is quickly cooled to ambient temperature by continuously spraying the circulating
water over the load.
This method of sterilization is the fastest method for sterilization of liquids in sealed containers.
Sanitary Piping Systems
All piping and ports in contact with the chamber are constructed of 316L stainless steel and are
sloped for drain-ability.
Easily removable sanitary clamp fittings are used for ease in removal of components.
Non-proprietary sanitary valves and components are selected for their reliability and availability
to reduce down time.
Validation
Every Medpharm water spray sterilizer is subject to rigorous pre-validation testing at the
factory and shipped with an extensive documentation package in order to minimize the time
required for on-site validation.
IQ/OQ protocols as well as on-site execution are available as options.
Program Parameter
|
Cycle name |
Further details |
Application |
|
Instruments/Tools |
3 times Vacuum, expose temperature 132, expose time 8 min, drying time 5 min. |
Solid materials to be sterilized: Packaged instruments Empty glass containers Empty metal containers Porous materials to be sterilized: Rubber articles |
|
Clothing |
3 times Vacuum, expose temperature 121, expose time 15 min, drying time 25 min. |
Materials to be sterilized from which air can’t be easily displaced Textile |
|
User Programmable |
All preset parameters can be reset; Multiple customized programs can be set and stored by user. |
Customized |
|
Test programs and utilities |
||
|
B-D Test |
3 times Vacuum, expose temperature 134, expose time 4 min, drying time 3 min. |
Test program |
|
Vacuum Leakage Test |
Test the chamber connecting parts’ tightness effect. It’s important to ensure the sterilization effect. |
Test program |
