BSM flexible clinical scale aseptic filling system do not restricts the choice of the container and has been considered a revolutionary solution by pharma manufacturers.Berkshire Sterile Manufacturing in collaboration with Fedegari is now able to offer a cost-effective solution using a flexible isolator based sterile manufacturing system. BSM is already working closely with pharmaceutical industries to help advance their product candidate into the pre-clinical or clinical setting. 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. Flexibility in primary containers The result of the collaboration between Fedegari and Berkshire is an isolator based filling system that 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) custom containers (glass and plastic) The system works with both liquid and lyophilized products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator. “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. Syringe Filling Vial Filling Lyophilization Specialty Filling Cartridge Filling Terminal Steam Sterilization The new Berkshire Corporate Center was inaugurated last year. It is equipped with the newest and most advanced technologies in the market – including Fedegari process equipment – to manufacture sterile drugs. Learn more at: http://fedegari.com

1. CLEANROOM
TECHNOLOGY
November 2016 49
STERILE FILLING
FLEXIBLE CLINICAL SCALE FILLING
SYSTEM FOR ALL CONTAINERS
Berkshire Sterile Manufacturing is implementing a cost-ejfective production strategy using a
flexible isolator-based sterile manufacturing system engineered by Fedegari
Many aseptic contract manufacturing
organisations face the challenges of small
batch sizes, varying primary container
types and sizes, and customer
expectations of the latest technologies in
sterile manufacturing.
lt is cost-prohibitive to have multiple
production lines, each of which is
dedicated to one primary container type
(vial, syringe, cartridge or custom).
Isolators represent the current trend in
sterile filling technologies, but can add
significant capita! expense to process
manufacturing.
'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 vapour
hydrogen peroxide far all primary
container packaging,' explains Shawn
Kinney, CEO of Berkshire Sterile
Manufacturing (BSM).
BSM is implementing a cost-effective
strategy using a flexible isolator-based
sterile manufacturing system to face all
these challenges, and clean and sterile
process equipment developer Fedegari is
involved in this endeavour with experts in
various aspects offill, finish and
contamination control technologies.
The result of this collaboration is an
isolator-based filling system that is able to
fill the following primary containers:
• bulk glass vials,
• pre-sterilised nested vials (glass and
plastic) and syringes (glass and plastic)
• pre-sterilised nested cartridges (glass
and plastic)
• custom containers (glass and plastic)
The system works with both liquid and
lyophilised products and the primary
containers do not have to be exposed to
hydrogen peroxide before entering the
isolator.
Giuseppe Fedegari, president of
Fedegari Group, explains: 'More than
supplying state-of-the-art equipment to
Berkshire's new facility, we are investing
in this partnership to face the challenges
The view from outside Berkshire Sterile
Manufacturing's new cleanroom
Low volume sterile filling within a flexible isolator
system
of the post-blockbuster pharmaceutical
industries.'
He adds: 'We have worked together with
BSM to design and develop the highest
performance customised solutions far the
American market. This collaboration is a
very promising beginning to a long and
fruitful co-operation. Our partnership is
making available the excellence in sterile
manufacturing to improve drug industry
productivity in many aspects.'
The biopharmaceutical start-up from
Lee in Berkshire County, Massachusetts,
focuses on contract manufacturing sterile
drugs in the pre-clinical and clinica!
phases far pharmaceutical, biotech, and
medica! device companies at its new
facility.
lts services include the filling of
syringes, vials, cartridges and dual
chamber devices and it also provides
formulation development, terminal
sterilisation, freeze-drying, analytical
chemistry and microbiologica! testing,
quality assurance and stability studies.
BSM's goal is to address the risks that
are associated with drugs produced by
small sterile drug manufacturing ...
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