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

Scapa Healthcare

Scapa Healthcare specialize in providing wound dressings at their site in Gargrave, UK. The viscous mixture produced at this site is one of the key components in the manufacture of one of their wound dressing products. Briggs of Burton have a long standing relationship with the client previously providing mixing systems. Briggs were appointed to design and build a facility to improve and increase their production capacity and inhouse capability.

The Briggs Pharma Engineering team led the creation of a User Requirement Specification (URS) in the early stages of the project, developed P&ID drawings and 3D models for the client to visualize their new facility. During the detailed design, Briggs conducted a HAZOP with the client to mitigate any process risks. With process support from Briggs the client converted an existing storage and packaging area into a clean room which houses the Briggs 2 vessel sanitary mixing solution with a fully compliant control system and HMI operator interface.

The Briggs team supported the client with their IQ, OQ and PQ validation processes which also included product trials and operator training. The project was delivered within the time scale set by the client and Briggs look forward to developing future systems with Scapa Healthcare globally.

Pharma Equipment

  • An aseptic vessel for the manufacture of a highly viscous ointment complete with.
    • Lid lift
    • Contra-rotating agitation with anchor scraper
    • Homogenizer
    • Thermal regulation jacket for both cooling and heating
    • Pressure and Temperature control
    • Level monitoring
  • A Phase vessel complete with
    • Agitator
    • Heating jacket
    • Pressure and Temperature monitoring
    • Level monitoring
  • A variety of mobile product addition/ recirculation pumps
  • Mobile access platforms
  • Vacuum transfer system
  • Fully compliant control system and HMI operator interface

Pharma Engineering

  • Detailed mechanical and electrical design
  • P&ID Development
  • URS Development
  • Equipment specification
  • Equipment layouts
  • 3D modelling
  • Project Engineering
  • Equipment procurement
  • Project planning
  • Specialist skid manufacture
  • Site management of mechanical and electrical installation
  • Commissioning
  • Preparation of all documentation and operation and maintenance manuals
  • Site Acceptance Testing (SAT)
  • Validation Support (IQ, OQ and PQ)
  • Training
  • After Sales Support

Flammable Flavourings Handling and Production

US company with a UK manufacturing operation. Producing flavours for Red Bull

Overall Scope

  • Sugar dissolving systems
  • Stainless steel distillation system including bespoke vapour condenser.
  • Vacuum, steam, water, cooling and chilling systems
  • Flavour Preparation Vessels
  • Scrubber system receiving vapour/vent from still and tanks.
  • High Integrity CIP system – ‘dump to drain‘ to prevent cross-over and taint issues for product quality
  • ATEX-rated SCADA/PLC control system

Offering the Hard Seltzer Industry

  • Concept Studies / Front-End Loading (FEL 1-3)
  • Detailed Design
  • Specialist Equipment Design and Manufacture
  • Leading Hard Seltzer Technologies
  • Process Engineering
  • Project Management
  • Functional Safety and Hazardous Area Design
  • Automation and Control

11 Skid based mixing systems

Briggs of Burton have supported a major pharmaceutical company in designing, building, and commissioning a complete mixing suite capable of producing sterile aluminium salts. Aluminium salts are recognised to enhance the human body’s response to immunisation. 11 New skids and CIP system were manufactured at Burton on Trent for the new pharmaceutical production facility located in Scotland.

Project Scope

  • 11 Pre-assembled vessel skid assemblies including solution preparation, precipitation, mixing, sterilisation, and cooling processes
  • Vessel design and manufacture
  • Integration of filters, mixers, and associated equipment into vessel skid assemblies
  • Pipework to services in the ceiling void, to downstream processes and interconnection between skids
  • Interface with Water for Injectables (WFI) supply
  • ATEX rated for ammonia use
  • Local panelling and remote IO for interface with Delta-V system (provided by others)

Engineering Services

  • Design works including 3D modelling
  • Mechanical design and manufacture
  • Project management
  • Construction management
  • Supervision of mechanical and electrical installation
  • Factory Acceptance Testing including riboflavin testing
  • Site Acceptance Testing and commissioning
  • Training

Second Generation Biofuel Pilot Facility

Briggs of Burton worked with TMO Renewables to design and build their Process Development Unit (PDU) to scale-up from current laboratory operations and also optimise a bioethanol process for the commercialisation of the technology. The PDU was designed to be capable of accepting a wide variety of raw material feed stocks to generate ethanol from fermentable sugars, and also included a smaller scale pilot “Scale-through” plant.

Project Scope

  • Raw material handling including storage, weighing and batching of raw material
  • Pre-treatment to adjust moisture content, pH and high temperature thermal hydrolysis of raw material plus Flash Vessel
  • 2 Stage high solids loading enzyme hydrolysis of pre-treated material to degrade biomass and release fermentable sugars with external heat exchangers – 1 x 12,000 L & 2 x 6,000 L
  • 3 Stage bacterial culture growth system
  • Batch & Continuous Fermentation of enzyme hydrolysed material to convert sugars to Bioethanol with external heat exchangers – 2 x 6,000 L & 1 x 1,000 L.
  • Product handling including receipt, treatment and storage / disposal of fermented product and other waste materials – 2 x 27,500 L.
  • 1/10 size Scale-through plant comprising; Reactor, Flash Vessel, 160 L2 x 60 L enzyme hydrolysis vessel and fermentation vessels.
  • Scrubber system
  • 3 tank recovery CIP system, plus SIP facilities.
  • Dedicated enzyme & chemical dosing systems
  • Utilities generation and distribution required to operate the process areas detailed above; steam, electricity, water, chilled water, compressed air.

Engineering Services

  • Innovative process design of novel processes including Steam Explosion Thermal Pre-treatment, High solids hydrolysis and fermentation.
  • Process Flow Diagrams (PFDs)
  • User Requirement Specification (URS)
  • Capacity planning including utility and effluent loading
  • Overall Plant configuration and equipment sizing
  • Piping and instrumentation diagram (P&IDs)
  • 3D Model and 2D Layouts including major equipment and piping
  • Electrical design and implementation
  • Functional Design Specification (FDS)
  • Automation Control system and software writing
  • HAZOP review

Compounding Vessels and Clean in Place (CIP) System

Briggs of Burton has recently worked with a global pharmaceutical company that ranks among the leading generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers and runs a specialty business focused on respiratory, allergy and psychiatric therapies.

Pharmaceutical Equipment

Briggs of Burton designed, engineering and built a range of sanitary vessels. All of the vessels manufactured were capable of a 5 bar pressure rating and featured a high standard of internal finish (<0.5 microRa internal finish after electro-polishing). Vessels were also fitted with agitators and in-line equipment including: sprayballs, valves, sight glasses and bursting discs.

  • 300 Litre mobile vessel
  • 1,500 Litre fixing compounding vessel
  • 300 Litre CIP vessel
  • Pipework and skid frames
  • Local panels and instrumentation

Pharmaceutical Engineering Services

Detailed mechanical and electrical design.

  • Equipment layouts
  • 3D modelling
  • Project engineering
  • Equipment procurement
  • Project planning
  • Supervision of mechanical and electrical installation
  • Commissioning
  • Preparation of documentation and operation and maintenance manuals
  • Design Qualification (DQ)
  • Factory Acceptance Testing (FAT)
  • Installation Qualification (IQ)
  • Site Acceptance Testing (SAT)
  • Training

Chemical Handling System

Briggs of Burton has helped the UK manufacturing site of a world leader in embedded applications to install a chemical handling system. The site is primarily involved in the research and development of hardware and software solutions for low-power wireless networks and Internet of Things (IoT). The chemical handling system supports the overall production process and required specialist pipework to handle the potentially hazardous chemicals.

Project Scope

  • PFA pipework
  • Fittings
  • Valves
  • Flow coding
  • Electrical equipment
  • Field wiring
  • Instrumentation
  • External trace heating

Capable of handling a wide range of chemicals including:

  • Sulphuric Acid
  • Hydrogen Peroxide
  • Hydrochloric Acid
  • Ammonia
  • Hydrogen Fluoride

Engineering Services

  • Project Management
  • Process Engineering
  • CAD / Draughting
  • Electrical, PLC and SCADA Engineering

Novel Agarose Bead Production Facility

Purolite Life Sciences’ have invested in a multimillion pound production facility in Wales capable of producing 30% of the world’s agarose demand. The state-of-the-art manufacturing facility designed and built by Briggs of Burton will be located at Purolite’s R&D Centre of Excellence in South Wales. It will be capable of producing 100,000L of high flow agarose resin for their Praesto® range of ion-exchange and Protein A affinity resins, designed for the purification of monoclonal antibodies.

Bespoke Production System

Briggs of Burton supported Purolite in scaling up their process that is capable of handling a range of liquids and powders to produce their product range. Process and Tank Farm/Utility Vessel Package including:

  • Wide range of heating and cooling vessels with agitators
  • Several mobile vessels fitted with agitators
  • A number of wash columns

Integration of Utilities:

  • Design and integration of compressed air and nitrogen systems
  • Chiller system and purified water system
  • Segregated effluent system design to storage tanks
  • Bulk chemical and waste distribution design and storage
  • IBC/drum & dry goods transfer/pumping stations & distribution design

Automation and Control:

  • Complete electrical design and installation
  • Complete Siemens platform SCADA
  • Control room

Engineering Services

Briggs of Burton were successful in completing the Front End Engineering Design (FEED) and the subsequent Detailed Design, which included the following deliverables.

  • Process Flow Diagrams (PFDs)
  • Basis of Design
  • User Requirement Specification (URS)
  • Capacity planning including utility and effluent loading
  • Support on emissions modelling during planning
  • Overall plant configuration and equipment sizing
  • Piping and Instrumentation Diagram (P&IDs)
  • 3D Model and 2D layouts including major equipment and piping
  • Electrical design and implementation
  • Automation control system and software writing
  • HAZOP review
  • DSEAR/ATEX risk assessment, zone specification & explosion protection document

Irish Malt Distillery Mashing Plant

Briggs of Burton’s Distilling team supported Beam Suntory in the complete design and installation of a new mashing plant at Cooley Distillery. Cooley Distillery features both pot and patent stills allowing them to produce both malt and grain whiskey including famous brands such as Kilbeggan, Tyrconnell, Connemara Peated Single Malt and Greenore Single Grain Irish whiskey.

Distillery Equipment

Briggs of Burton Distilling team designed and engineered:

  • Dry Goods Handling system including Grist case and Pneumatic slide valve
  • New Mashing Plant including Briggs Steeles masher,  4.5m diameter Full Lauter Tun, Draff chute and Wort/CIP pump, valves and in-line components
  • Upgrade included new electrical and process control including electrical design, supply and installation
  • MCC/Control panel and Instrumentation
  • PLC/SCADA automation and control using existing WinCC SCADA and New S7 400 PLC with new remote I/O equipment
  • Training and Software simulation

“We replaced their existing Mash Tun (4.9m, 5.80 Te charge, 14 h turnaround time) with new Briggs Distillery Lauter Tun (4.5m, 3.2 Te charge, 6 h turnaround time). The new smaller tun is quicker and more efficient, achieving >98% extract recovery.”

John Hancock, Briggs Technical Director