OzUK Unveils New ATEX-Rated Pilot Plant for Low GWP Product Development
At OzUK, we are proud to announce the installation and qualification of our state-of-the-art pilot plant, designed to support the development of metered dose inhalers (MDIs) using low Global Warming Potential (GWP) propellants. This cutting-edge facility, fully compliant with ATEX (Atmosphères Explosibles) directives, enables OzUK to produce both solution and suspension batches using 152a for pilot and feasibility studies under Good Laboratory Practice (GLP).
Advancing Innovation with Sustainable Propellants
As regulatory and environmental pressures increase the need for sustainable alternatives to traditional HFA propellants, OzUK’s pilot plant is positioned at the forefront of the industry, supporting clients in developing MDIs with low GWP propellants. By focusing on GLP rather than full GMP compliance, we offer a flexible, efficient pathway for iterative product development and testing, allowing clients to innovate at a rapid pace without compromising safety or quality.
Key Features of Our Pilot Plant
Fully ATEX Rated: Our facility meets stringent ATEX safety requirements, allowing us to work safely with HFA 152a essential for aerosol and inhalation formulations as well as HFO1234Ze and legacy propellants.
Solution & Suspension Batches: Whether clients require solution-based formulations or suspension systems, our pilot plant is equipped to handle both, meeting diverse project needs.
Flexible Production for Pilot & Feasibility Studies: From early-stage concept testing to detailed feasibility studies, our pilot plant is adaptable to various project phases, making it ideal for those seeking agile development.
Streamlined Development Under GLP
Operating under GLP standards offers our clients a streamlined approach to testing, stability studies, and iterative development, providing valuable data without the constraints of full GMP. This flexibility enables pharmaceutical companies to refine formulations and conduct stability assessments with ease, making it faster and simpler to evaluate the potential of new or reformulated molecules before scaling up to GMP manufacturing.
Comprehensive Development Programs & Testing Services
Beyond batch production, OzUK offers comprehensive development programs for novel and reformulated molecules in new low-GWP propellants. Our expertise in the MDI field, coupled with advanced testing services, ensures that clients receive support at every stage of development. From initial formulation through to performance testing, stability programs, and regulatory documentation, OzUK’s services are designed to facilitate seamless product commercialisation.
Partner with OzUK for Leading MDI Innovation
At OzUK, we understand the challenges and opportunities associated with transitioning to sustainable propellant options. Our new pilot plant is a testament to our commitment to innovation and environmental responsibility in the pharmaceutical industry. Whether you are looking to develop a novel molecule, reformulate an existing product, or simply explore the potential of low GWP propellants, OzUK provides the resources, expertise, and flexibility to support your journey.
Contact us today to learn how OzUK’s pilot plant and development services can help bring your MDI products to market with confidence.
