ELPEN Pharmaceuticals: pMDI engineering and mixing system

Briggs of Burton are leading providers in sustainable pressurised metered dose inhalant (pMDI) mixing systems. Interfacing with up/ downstream equipment suppliers Briggs led the end to end project delivery. Our engineering experts provided a wide range of inhouse services including detailed design, engineering, bespoke manufacturing, inhouse automation, installation, commissioning and a fully ASME BPE validated system.

ELPEN Pharmaceuticals established in 1965 is one of Greece’s largest manufacturers of pressurized Metered Dose Inhalers (pMDI).

The Briggs Pharma Engineering team designed and engineered a system that can manage three variations of pMDI mixing for the client:

• Single Stage Filling: Active Pharmaceutical Ingredient (API) and Hydrofluoroalkane (HFA) formulation completely pre-mixed.
• Dual Stage Filling: The API and Ethanol formulation is pre-mixed with HFA, more pure HFA is subsequently added.
• Two Stage Filling: The API and Ethanol formulation are pre-mixed without the HFA. The HFA is added to the can afterwards through the valve system.

In anticipation of a planned legislative change to reduce the use of GWP propellants, our team are helping customers transition towards the new generation of pMDI’s. Our engineers have evolved the design of our pilot and commercial mixing systems to incorporate the latest sustainable technologies.

Our engineering team successfully delivered the project within the time scale set by the client. In addition, we are looking forward  to working and developing the next generation of inhalant mixing systems for Elpen Pharmaceuticals in the future.

To get an insight into how pMDI’s are made, follow this link: (2) Briggs of Burton pMDI mixing system – YouTube

Pharma Engineering Equipment

• Design and integration of conditioning vessels, solutions mixing vessel and suspension mixing vessel along with multiple Drug additions vessels to support Single Stage, Two Stage and Dual Filling processes
• Integration of filters, mixers, pumps, and associated equipment into vessel skid assemblies
• Pipework connections to services and to downstream filling process that interface with filler, in terms of control
• Interface with utilities including CIP/SIP, purified water, and sterile air
• Standalone automation system with PLC control and HMI with recipe control
• ATEX rated

Pharma Engineering Services

• URS Development
• Process Design
• 3D Modelling
• Complete software design
• Mechanical design and manufacture
• Project management
• Project engineering
• Development of a validation plan and leverageable FAT protocol
• Develop the design of a top of the range hygienic, ASME BPE compliant system
• Specialist skid manufacture
• Factory Acceptance Testing including riboflavin testing
• Supervision of mechanical and electrical installation
• Preparation of a comprehensive documentation file
• Commissioning