Proveris’s Actuation Parameter Determination Services
Drug developers that engage Proveris for actuation parameter determination services, commonly known as Ergo™ device hand studies, produce better spray and aerosol drug products that reach patients faster than ever before. They also save millions of dollars in development costs. The service is a component of Proveris’s Quality by Design [QbD] patented process, Proveris by Design™. Results from actuation parameter determination services have helped laboratories select pumps and devices. They have also reduced, if not eliminated entirely, the need for costly re-testing later in the development cycle when a problem is discovered that could have been discovered with a hand study. The results of actuation parameter determination studies thus reduce pharmaceutical spray and aerosol drug development time and costs.
Who should care?
Pharmaceutical spray and aerosol drug developers who want to:
- streamline their product development efforts
- simplify the transfer of development methods to production for release testing
- reduce overall development time by 12 to 18 months
- save millions of dollars in development costs
- comply with current FDA guidelines and reduce the risk of problems during regulatory review
How does a hand study fit into the Proveris by Design process?
The Proveris by Design process is a patented, step-by-step testing protocol that begins with a hand study and takes pharmaceutical spray and aerosol drug developers from pump selection to release testing for the life of a drug product. The process is rooted in Proveris’s deep understanding of regulatory guidelines and stems from Proveris’s experience helping global drug developers improve the quality of regulatory submission packages. What results? Better spray and aerosol drug products that start helping patients sooner than ever.
Why does the Proveris by Design process help?
The Proveris by Design process helps by:
- establishing an optimized range of actuation parameters that can be used to perform spray and aerosol tests for the life of the product.
- reliably determining the length of a spray drug’s conical region and the plume angle.
- providing a scientific basis for distances employed for spray pattern and droplet/particle size distribution by laser diffraction tests.
- measuring how people in the drug product’s age and gender range use the product and using the measurements as the basis for programming our Vereo actuation systems to help ensure the effectiveness of spray and aerosol drugs and ultimate patient safety as recommended by the FDA.
- supporting Process Analytical Technology [PAT] and QbD principles.
- providing a solid, scientific basis for method establishment and assisting with regulatory requirement compliance.
When should actuation parameter determination services be performed?
Pharmaceutical spray and aerosol drug developers that began the Proveris by Design process during the pump selection stage have reduced overall development time by 12 to 18 months. They have also saved millions of dollars.
Starting the process later in development can also save millions of dollars by reducing costly set backs after significant funds have been spent, when problems are discovered that could have been discovered months, if not years, earlier.
Where can I learn more about actuation parameter determination services and the Proveris by Design process?
Contact Proveris for more information regarding the Proveris by Design process and how it can help your company streamline its spray or aerosol drug development, reduce time to regulatory submission, save millions of dollars, and ensure drug product efficacy and safety.