Consort Medical, has developed an innovative UnidoseTM Xtra nasal spray device to provide unique performance advantages through a novel, patented device actuation and drug delivery solution. The nasal route is particularly suitable for delivering drugs that require rapid onset of action. Example applications include the treatment of anaphylaxis, pain, migraine and, in particular, opioid overdose.
The UnidoseTM Xtra device is compact, simple and intuitive to use, with a low actuation force and a reliable drug delivery that is independent of the force or speed being provided by the end user.
Consort Medical, is providing API and finished dose formulation development and manufacturing service for the device, and as part of this service had a requirement to establish highly flexible but scalable liquid filling and stoppering system capable of precisely filling a wide range of different liquids and viscosities. In addition, the system needed to be designed for GMP manufacture and capable of nitrogen flushing the drug container for oxygen-free filling and stoppering of their cartridge.
In response to the above, and conscious of the increasing pressures from regulatory bodies such as the FDA to automate more to improve the safety of drug manufacturing for both end product and operators, 3P innovation designed and manufactured a versatile, lab-scale liquid filling and vacuum stoppering system, our Liquid Fill-Finish Platform, capable of filling cartridges, vials, syringes and other special containers. The core filling and stoppering processes are automated and inherently scalable, avoiding the need to revalidate the process when faster production speeds and higher throughput is required.
The machine helps clients by providing:
- A cost-effective means to develop and de-risk new devices and combination products at an early stage in their project.
- Valuable insight and clear understanding of manufacturing process and capability – providing data essential to ensure a robust manufacturing process that will stand up to scrutiny and validation.
- Top quality equipment with which to demonstrate manufacturing know-how and scale-up route to their end customers.
- The means for quick and easy manufacture of pre-clinical and GMP volumes of product to support clinical trials, performance testing, human factors studies, stability trials etc.
Developing and refining device design has never been easier. This invention allows for the end-product to be tested sooner to measure feasibility quicker. In addition to that, the individual unit operations are representative of production, meaning that validation does not need to be repeated when a scaled-up solution is required. The result is a faster product launch and faster ROI.
3P’s servo-controlled filling system provides extremely accurate filling needle positioning, allowing for bottom-up control, avoiding splashing, frothing or contamination of the stoppering zone. A variety of pump technologies can be integrated, including peristaltic and rotary piston pumps, providing variable flow-rates and catering for all liquid types and viscosities. The servo-controlled, vacuum stoppering system provides finely-adjustable and precise placement of stoppers, enabling quality critical device features to be achieved. An optional Nitrogen purge station is also available for oxygen-sensitive drug products.
The cGMP filler is flexible, scalable, easy to use and clean, and can be integrated with other modules for higher-volume semi-automated and fully automated production. Fully sterile machine options are also available, capable of aseptic manufacturing and resistant to HPV / VHP and other sterilisation methods.
''3P listened to our needs and responded with flexible, precise and user-friendly machines that have been invaluable in helping us to understand and develop our device more effectively. Our operators have all commented on just how easy and intuitive it is to use! Thank you 3P for your close cooperation and for a quick turn-around!'' - Dave Bland, Development Director at Consort Medical