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.

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.