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BK357 Metered Dose Inhaler (MDI) Valve and Actuator

The BK357 MDI Valve

As the most technically complex element in a metered dose inhaler (MDI), the valve is critical to delivering a consistent and precise metered dose of medication to patients.
Our MDI valves are firmly established as one of the major HFA valves worldwide, forming a critical component in several FDA approved products. They have been developed to work with a wide range of formulations with low levels of extractables and leachables to ensure that they are both versatile and clean.

Valves

Manufacturing

  • Constructed from regulatory approved plastic, metal and elastomeric materials
  • Specifically developed proprietary elastomer formulation
  • Cleanroom manufacture
  • Supported by in-house elastomer and ethanol extraction manufacturing facilities
  • Robust cGMP compliant commercial supply chain

Device

  • Capillary retention design
  • Exceptionally low levels of extractables and leachables
  • 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
  • Anodised ferrules for cleanliness
  • High speed pressure filling by design
  • Ability to cold fill
  • Designed to fit 20mm neck containers

Customisation

  • Suitable for ethanol and non-ethanol formulations
  • Inverted or upright use with diptube
  • Standard dose size ranges from 25-100µl
  • 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
  • Complimentary press & breathe or dose counting actuators available to optimise valve performance

Support

  • Valve performance supports inhaler shelf life up to 3 years
  • Dedicated in-house laboratory to support product testing
  • DMF documentation available

Actuator

Our actuators are optimised to work with our MDI valves and common canisters. They are 100% airflow tested and supplied ready for immediate use in final packaging operations. Should you need exclusive actuator designs or formula-specific devices, we develop customised actuators in parallel with the chosen container closure system.

Actuators
 

Key Features

  • Available in 2 body lengths to accommodate 14ml and 19ml canisters
  • Supplied with dust cap to keep mouthpiece clean
  • Range of exit orifice diameters and lengths available to suit end application
  • Orifice diameters range from 0.22mm to 0.58mm
  • 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 chain

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