Next Generation Propellant Technology for Pharmaceutical MDI Applications
Challenge from the Client
A global manufacturer and distributor of bulk propellant materials, infrastructure products and services develops the next generation of fluorine-based novel product propellant technology for pharmaceutical metered dose inhalation (MDI) applications.
This project extended our clients current business scope of operation in line with their integration strategy of delivering products and services for MDI by:
- Providing CGMP development, pre-clinical sample materials supply and testing service to organization’s seeking to bring MDI products to market.
- Providing contract manufacturing capability to organisations seeking to supply clinical and product launch materials to market based on novel propellant product technology.
- Providing contract manufacturing capability to organisations seeking to outsource or supplement their MDI product manufacturing and distribution capabilities.
Our Approach & Solution
By taking a modular and “plug and play” approach to process design, full production operation for the commercial line will increase to 500 litres bulk manufacturing scale producing 40,000 aerosols per batch.
The manufacturing process was based on flammable propellants that required ATEX zoned areas. Both the manufacturing formulation and filling equipment were located in controlled operating environments having a minimum cleanroom classification equivalent to EU GMP classified Grade D, and ATEX ratings of Zone 1 for the manufacturing and Zone 2 for the filling room. Both manufacturing and filling rooms had pressure-relieving and pressure-resistant building construction to minimize the damage caused by the potential for combustion explosions whilst maintaining full cleanroom environments. The facility design and site master planning allowed for multiple MDI line additions as business grows over time without impacting current manufacturing/filling operations.
An external service yard with hazardous bulk material storage area for bulk API propellant, solvent intermediates and solvent recovery systems was connected by overhead pipe bridges to the new facility.
The Health Hazard Categories for the active ingredients range from OEB2 to OEB4. Exposure control strategies are commensurate with exposure risk. This is accomplished through guidance providing appropriate risk-based exposure control strategies for the processing equipment.
Initially, UK MHRA licences will be obtained, closely followed by US FDA and other significant worldwide equivalents.
IPS provided technical expertise with their understanding of site master planning new facilities and infrastructure as well as define MDI process technology, supporting infrastructure and environmental design requirements.
The initial design concepts and 3D visualisations of both process and facility enabled the client to leverage new commercial opportunities within the MDI market sector and in parallel develop their business case and capital investment required to progress the project internally.