Bespak Scale-up to Manufacture Unique Bromobutyl Elastomer
Bespak, a leader in devices for inhaled drug delivery and anaesthesia, has today announced its intention to scale up manufacture of its unique Bromobutyl Elastomer formulation for use in pressurised Metered Dose Inhalers (pMDIs).
The formulation, realised by Bespak's in-house team of developers, offers pharmaceutical partners a compatible elastomer with lower leakage and lower moisture ingress characteristics than current alternatives and that demonstrates comparable leachables and shot-weight profiles.
Chosen for its inertia to both ethanol and HFA propellant, Bromobutyl was selected as the base polymer and Bespak engineers have further developed the formulation using a unique accelerator to enhance the curing process and minimise extractables.
The formulation has been scaled up to Process Qualification (PQ) stage at Bespak's dedicated Elastomer facility in King's Lynn and is already on trial with a number of customers. The purpose-built, state-of-the-art facility commissioned in 2005 will, at full production, be capable of delivering all of the anticipated annual demand for valve seats and gaskets.
Richard Warby, Bespak's Principle Manager for Valve & Actuator Development, commented, "Since 1995, pharmaceutical partners have had a limited choice to make when specifying an elastomer for their device development programmes. Our Bromobutyl offers customers a credible, robust and proven alternative to the established options."
Chris Hall, General Manager of Bespak's Respiratory division, added, "The development of our own in-house elastomer is a major step forward for Bespak and its clients. When you consider the complete package of support we are able to offer, from integrated dose counting actuators to our novel Easifill valve and now a unique elastomer, we can truly claim an unrivalled capability in the development and manufacture of pressurised pMDI valves."
Notes for editors
About Bespak plc
Bespak plc is a leader in devices for inhaled drug delivery and anaesthesia. The Group develops drug delivery systems for the pharmaceutical industry and disposable airway management products for critical care settings in hospitals. Bespak develops and manufactures metered dose inhaler valves, actuators, compliance aids, dry powder devices, disposable face masks, breathing circuits and laryngeal tubes. The Group has facilities in King's Lynn and Milton Keynes in the UK, Indianapolis, Indiana and Kent, Ohio in the US, and Mumbai, India. Bespak is a public company quoted on the full list of the London Stock Exchange (LSE: BPK). For more information, please visit www.bespak.com
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