Consort Medical
Metered dose inhaler expert standing in manufacturing area in King's Lynn

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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