MDI VALVES AND ACTUATORS - Bespak

1 The valve is the most technically complex element in an MDI, and critical to delivering a consistent and precise metered dose of medication to users Our range of elastomers helps ensure our MDI VALVES are developed to work with a wide range of formulations and are particularly clean with exceptionally low levels of extractables and leachables Our ACTUATORS have been optimised to function with all common MDI VALVES and canisters. All capped ACTUATORS are 100% airflow tested and are supplied ready for immediate use in final packaging operations Where customers require exclusive actuator designs or formula-specific devices, we can develop customised ACTUATORS in parallel with the chosen container closure system. Through proven expertise and experience, customers can benefit from a total system approach which ensures that the delivered actuator partners the valve for optimum drug delivery MDI VALVES AND ACTUATORS At Bespak we are proud to say that we are a leading developer and manufacturer of metered dose Inhaler (MDI) VALVES , serving the needs of the global CLASS DEVICES.

2 DELIVERING QUALITY. AT EVERY , a Consort Medical Company, is a global market leader in the development and manufacture of drug delivery devices for Inhalation and Injectables markets. Bespak has contributed to the design, development and industrialisation of some of the world s leading medical devices. With an in-depth understanding of design for manufacture and a robust continuous improvement methodology, Bespak s programme management capability supports the full lifecycle of a product. Bespak supports device programmes from pilot-scale to commercial supply. Over 500m devices per annum 26,790m of manufacturing space 17,359m of clean rooms 30 fully automated assembly suites 125 injection moulding machines billion components assembled annually billion plastic components moulded annually Six sigma quality (less than defects/million) High standards of regulatory compliance, including ISO 13485 MHRA commercial drug handling license Figures correct as at.

3 Discover how we can support your needs @bespak_Valve key features Firmly established as one of the major HFA VALVES worldwide Established 35+ year pMDI technology Approved by the FDA for multiple products Robust cGMP compliant commercial supply chain Capillary retention design Designed to fit 20mm neck containers Suitable for ethanol and non-ethanol formulations Standard metering chamber volumes of 25, 40, 50, 63 and 100mcl Inverted or upright use with diptube Constructed from regulatory approved plastic, metal and elastomeric materials Available with EPDM, Nitrile and Butyl seals Exceptionally low levels of extractables and leachables Design fine-tuneable to meet specific customer requirements: Leakage Shot weight Emitted dose Compatibility with active Usable with HFA propellant 134a and 227 Compatible with cut edge & roll neck aluminium or stainless steel canisters Compatible with glass bottle containers Consistent through life performance Low drug deposition onto material surfaces Low drug absorption into components Low moisture ingress Materials inert to interaction with formulation Loss of prime characteristics to support dosing regime Complimentary press & breathe or dose counting ACTUATORS available to optimise valve performance Anodised ferrules for cleanliness High speed pressure filling by design Ability to cold fill Valve performance supports inhaler shelf life up to 3 years Dedicated in-house

4 Laboratory to support product testing Supported by in-house elastomer and ethanol extraction manufacturing facilities Cleanroom manufacture DMF documentation availableActuators key features For use with a metered dose Inhaler Valve (MDI) inhaler Available in 2 body lengths to accommodate 14ml and 19ml canisters Supplied with dust cap to keep mouthpiece clean Full range of exit orifice diameters and lengths available to suit end application Standard orifice diameters of , , , , and Fully customisable sump geometry available 100% airflow tested to specification Available in standard range of colours or customisable to pantone reference actuator and dust cap can be provided with embossed detail or plain Polypropylene construction with 21 CFR material compliance Robust cGMP compliant commercial supply chai