Innovation meets sterile manufacturing!

25 September 2017

Fedegari is proud to take part at Berkshire sterile manufacturing (BSM) Workshop entitled “Innovation meets sterile manufacturing!“. The event will take place on October 19th at new Berkshire Corporate Center, Lee (MA) USA. The Center was inaugurated last year and is equipped with the newest and most advanced technologies in the market – including Fedegari process equipment – to manufacture sterile drugs.

Fedegari Group is proud to be among the sponsors of the workshop, together with OMPI, SiO2, Colanar, IMA, Clean Air Technologies, Germfree Bio/Pharma that will present innovative projects and their latest developments in sterile manufacturing. The workshop has limited spots and will engage all participants by providing them access to the  leading companies that work in the sterile manufacturing field. 

Flexibility in primary containers

During the workshop, our R&D Manager, Maria Luisa Bernuzzi, will present a project developed by Fedegari for BSM “A flexible filling System for all containers: work flow and use” . This innovative isolator based filling system offers flexibility for primary containers while working with both liquid and lyophilized productsThe system is able to fill different primary containers: bulk glass vials, pre-sterilized nested vials (glass and plastic), pre-sterilized nested syringes (glass and plastic), pre-sterilized nested cartridges (glass and plastic) and custom containers (glass and plastic).

It is cost prohibitive to have multiple production lines, each of which is dedicated to one primary container type (vial, syringe, cartridge, or custom).  Isolator based ‘flex’ lines capable of multiple containers have been used by some industries, but most are unable to accommodate bulk glass vials and some require previous treatment with vapor hydrogen peroxide for all primary container packaging”, explains the CEO of BSM, Shawn Kinney.

“We have worked together with BSM to design and develop the highest performance customized solutions for the American market. This collaboration is a very promising beginning to a long and fruitful cooperation. Our partnership is making available the excellence in sterile manufacturing to improve drug industry productivity in many aspects”, said Giuseppe Fedegari, president of Fedegari Group.

 

Technical discussions and hands-on sessions

After the presentations, BSM will be taking participants on a tour of the facility where they will be able to explore the state-of-the-art solutions and equipments used by the CMO. Attendees will have the possibility to meet with each sponsor to learn through either a technical talk/discussion or hands-on activity.

BSM Innovation workshop is a great opportunity to improve your knowledge and to keep up to date with the innovations in sterile manufacturing.

With the necessary experience and capability to provide quality services that do not restrict the choice of the container, BSM is the unique CMO that incorporates 100% isolator technology to the filling lines utilizing state-of-the-art equipment. This technology allows to remove the risk of human contamination from the filling and formulation process as highly suggested by FDA, EMEA and other regulatory bodies.

 

bsm-fedegari -sterile-manufacturing

Save the date:

October 19th

 

Where?

480 Pleasant Street | Lee, MA 01238 | (413) 243-0330

 

When?

The event is on October 19th at 2 p.m.

 

INFO

info@berkshiresterile.com

 

RSVP

Find out more about this event or register from this link:

http://berkshiresterilemanufacturing.com/innovation-rsvp/

 

Learn more about BSM Aseptic Filling Services

 

Syringe Filling
Vial Filling
Lyophilization
Specialty Filling
Cartridge Filling
Terminal Steam Sterilization