Fedegari Tech Center Tour – ISPE 2018 Annual Meeting & Expo

The facility tour of Fedegari Tech Center (Sellersville, PA) took place during ISPE 2018 Annual Meeting & Expo, on November 7th, in Philadelphia.

During this ISPE meeting, over 20 visitors gained the exclusive opportunity to extend their knowledge with our experts discussing the main challenges on how to improve pharma manufacturing with the latest technologies and robotized solutions.

‘Fedegari Tech Center is equipped with various process machines for hands-on training and tests, simulating the same activities pharma industries carry on at their sites’, explains Jeffrey Siterlet, Managing Director of Fedegari Technologies.

Fedegari 10.000 square-foot facility in Sellersville (PA), currently under expansion, has recently been equipped with a machine prototype. The system is intended to wash, sterilize and dry aluminum kegs to be filled with sterile powder. All the activities are carried inside a gloveless robotized isolator downstream of the process machine.

The prototype has been presented by Fedegari experts and Pierre Winnepenninckx from No Deviation Pte Ltd (Singapore), who explained how to introduce such disruptive solutions for contamination control in regulated manufacturing environments.

Pierre Winnepenninckx‘s key note entitled ‘Dare to reduce the risk’ was aimed to discuss the impact of innovative robotized solutions for clean and sterile processes in terms of risk reduction.

“We must put the patient in the center of everything we. By understanding our pharma process we are able to identify and control the risk to fully implement a risk based approach – explained Winnepenninckx.  The more manual the process is the higher the risk“, he concluded.

ISPE 2018

Over 2.000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo. The four-day conference focused on the promise of new developments that ISPE members are helping the pharmaceutical industry tackle. The theme this year was “Vision to Reality”.

Learn more at the event website

Equipment available at Fedegari Tech Center

‘Our Tech Center is available for pharma professionals and operators who need technical support, training and knowledge sharing on process expertise and cycle development. According to specific needs – such as the load to be treated – our experts study together the most effective cycle. We perform tests to deliver a tailor made solution for the many bio-/pharma manufacturing challenges’, concludes Siterlet.

Process equipment available at Fedegari Tech Center:

FCDV   Chemical bio-decontamination unit (hydrogen peroxide)

FOAF   Steam sterilizer / Steam-air sterilizer (moist-heat)

FOWS   Washer-sterilizer 

FOW   Super-heated water sterilizer

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