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.
It 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 capital 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 for all primary container packaging,' said CEO of BSM, Shawn Kinney.
Berkshire Sterile Manufacturing is implementing a cost-effective strategy using a flexible isolator based sterile manufacturing system to face all these challenges and Fedegari is involved in this endeavour with experts in various aspects of fill, 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) and 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 said: 'More than supplying state-of-the-art equipment to Berkshire's new facility, we are investing in this partnership to face the challenges of the post-blockbuster pharma industries.
'We are pleased that BSM has recognised Fedegari as a partner who shares their vision for an advanced, cost-effective and flexible pharma manufacturing.
'We have worked together with BSM to design and develop the highest performance customised 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,' Fedegari added.
The biopharmaceutical firm focuses on contract manufacturing sterile drugs in the pre-clinical and clinical phases for pharmaceutical, biotech, and medical device companies at its new facility.
Berkshire Sterile’s services include the filling of syringes, vials, cartridges, and dual chamber devices and also provide formulation development, terminal sterilisation, freeze-drying, analytical chemistry and microbiological testing, quality assurance, and stability studies.
BSM’s goal is to address the risks that are associated with drugs manufactured by small sterile drug manufacturing companies that lack adequate modern facilities and rigorous quality systems.
The company wants to alleviate these concerns by using state-of-the art manufacturing equipment, isolators, flexible sterile filling equipment, and modern cleanroom and terminal steam sterilisation capabilities.
The new Berkshire Corporate Center, inaugurated last October, is equipped with the most advanced technologies in the market – including Fedegari process equipment – to manufacture sterile drugs.
FDA, EMEA and other regulatory bodies have stated for years that contamination in cleanrooms are mostly generated by human intervention and for this reason, the use of isolators for all products requiring aseptic fillings have been highly suggested.
However, the lack of flexibility, cost and overall difficulty with employing this technology has hindered its wider embracement.
Over the past 10 years, a revolution in terms of technology has occurred on filling and container systems, and partnerships with the most innovative companies in pharma manufacturing is allowing CMO’s like Berkshire Sterile manufacturing to bring this technology to their customers.