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Innovative Solutions for Sterile Manufacturing – Moist-heat Sterilization
WHAT WE DO
We design and manufacture of state-of-the-art process equipment and systems for sterile manufacturing. Our high-performance solutions include custom moist & dry-heat sterilizers, washers, chemical bio-decontamination units, pharmaceutical closures processing systems, sterility test isolators, contamination control solutions and integrated systems with robotized handling.
HOW WE WORK
Our group has started working on various innovative solutions taking an original and unconventional approach: rather than focusing on a component or a technology, we are investing in developing deeper knowledge. A unique feature of Fedegari is its commitment to develop and manufacture components and technologies in-house.
Fedegari U.S. headquarters and Tech Center is located in suburban Philadelphia, PA. Our Tech Center is designed to be an industry resource for hands-on testing & training, replicating activities at actual bio/pharma manufacturing plants.
Sterile Manufacturing – Frequent Asked Questions
HOW TO STERILIZE LIQUIDS:
STEAM-AIR MIXTURE OR SUPERHEATED WATER?
This is a common question faced in sterile manufacturing when treating LVPs, especially if stored in deformable containers. It is often convenient to use superheated water spray or steam-air mixture sterilization processes in order to prevent the effects of differential pressures between inside and outside the containers. However, the selection of either one is often critical. Although both sterilization methods can achieve the same general performances, the final choice is dictated by process needs downstream of sterilization:
Does the load need to be dry?
Does the container show any sign of hydration?
How can the highest productivity be achieved?
Are other loads to be sterilized through the same machine?
FEDEGARI TECH CENTER USA
Fedegari Tech Center USA is located in Sellersville (PA) within Fedegari Technologies, Inc. facilities.
In Fedegari Tech Center USA customers can benefit from technical support, training and R&D personnel expertise on process and cycle development.
Fedegari Tech Center USA is equipped with the following process machines for hands-on training and tests:
Lab Division:
BINDER incubator
Industrial Division:
FCDV – Chemical bio-decontamination unit (hydrogen peroxide)
FOAF – Steam sterilizer / Steam-air Mixture Sterilizer (moist-heat)
FOWS – Washer-sterilizer
FOW – Super-heated water sterilizer
FEDEGARI TECH CENTER USA
Address 1228 Bethlehem Pike, Sellersville, PA 18960
Telephone +1 215-453-0400
Email info@fedegariusa.com
Tech Center
Tech Center
In our Tech Center customers can benefit from technical support, training and R&D personnel expertise on process and cycle development.
E-book 'F0' - How to use it?
On moist-heat sterilization processes, the F0 value is used for process setup, adjustment, control and validation. Want to learn more?
Talk to our experts
Talk to our experts
Are you facing any challenge on sterile manufacturing? We can support you.
Talk to our experts
Talk to our experts
Are you facing any challenge on sterile manufacturing? We can support you.
Schedule your visit
Tech Center
Tech Center
In our Tech Center customers can benefit from technical support, training and R&D personnel expertise on process and cycle development.
E-book 'F0' - How to use it?
On moist-heat sterilization processes, the F0 value is used for process setup, adjustment, control and validation. Want to learn more?
Talk to our experts
Talk to our experts
Are you facing any challenge on sterile manufacturing? We can support you.