ISPE 2018: Fedegari US Tech Center Tour

11 December 2018

Fedegari Tech Center Tour – ISPE 2018 Annual Meeting & Expo, on November 7th

A Knowledge sharing experience

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

Our Tech Center proudly received 20 visitors who have shared their knowledge with our experts discussing the main challenges on how to improve pharma manufacturing with the latest techonologies on robotized solutions for aseptic processing and contamination control.

 

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Fedegari Tech Center US

‘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.

‘Our Tech Center has been built to deliver tailor-made solutions for pharmaceutical professionals, operators, and engineers through training, technical support, cycle development, and knowledge transfer in process expertise. For example, before a unit is delivered, we can study a customer’s specific product and, through testing, develop an optimized cycle that can be pre-loaded and delivered on the unit.  Doing so allows our customers to reduce qualification time and utilize their equipment in commercial production much faster’, concludes Siterlet.

Fedegari 10.000 square-foot facility in Sellersville (PA), currently under expansion, has recently been equipped with a state-of-the-art 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.

 

Services Fedegari Tech Center US

Our Tech Centers are the perfect environment for end-users and experts to meet and exchange experiences for the development of new and cost-effective solutions to real-world problems. Through state-of-the-art centers, Fedegari aims to increase the interaction with partners and customers for continuous education in the field of sterilization and contamination control. To accomplish that, our company have invested more than $16 million in process equipment installed in the facilities in USA, Italy and UK (in partnership with Steritech).

Microbiological trials

• Microbiological assessment of sterilization effectiveness
• Microbiological assessment of depyrogenation effectiveness
• Microbiological assessment of decontamination effectiveness (with hydrogen peroxide)
• Microbiological assessment of washing cycles (Endotoxins reduction, microorganisms reduction)
• Microbiological assessment of washing/disinfecting cycles
• Microbiological assessment of washing/sterilizing cycles

Washers

• Cycle development of a washing cycle
• Cycle development of a washing/sterilizing cycle
• Cycle development of a washing/disinfecting cycle
• Cleaning validation protocol
• Spray coverage test

Sterilizers

• Cycle development according to customer’s URS
• Evaluation of chemical, microbiological quality of the product at the end of the cycle
• Evaluation of package integrity/quality at the endof the cycle
• Primary packaging stress test
• Cycle time optimization

Bio-decontamination Units

• Decontamination cycle development according to customer’s URS
• Evaluation of chemical, microbiological quality of the product at the end of the cycle
• Evaluation of package integrity/quality at the end of the cycle
• Decontamination cycle time optimization

 

After-Sales Services

• Installation/startup/commissioning
• Qualification (IQ/OQ/PQ)
• FAT & SAT
• Process/load optimization
• Validation
• Preventive maintenance plans
• On-demand maintenance services
• Revamping of old machines
• Process controller updating (SW e HW)

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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

Fedegari Tech Center / Fedegari Technologies, Inc.

1228 Bethlehem Pike
Sellersville, PA 18960 USA
T +1 215-453-0400
F +1 215-453-0406
info@fedegariusa.com

Contact us

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

INTERPHEX NY 2019

Fedegari is getting ready to join Interphex NY next April 2-4. We will showcase our latest developments on aseptic processing and contamination control for pharma manufacturing. At the exhibition, visitors will have the opportunity to explore the integration of different Fedegari processes and technologies, but not only.

 Visit us at Interphex New York, Javits Center – Booth #3461

Learn more about our participation at Interphex 2019