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R500 & R1000

R500 & R1000

The R500/R1000 machine range provides the opportunity to reduce or eliminate 'formulation for filling' steps in a new development; Integrating our world-leading Fill2Weight technology, it is capable of handling the most challenging powders with the worst flow properties, including spray-dried powders, pure API, micronised, blended and bulk lyophilised powders.

Challenge:

Drug and device manufacturing is costly, time consuming and can present multiple challenges, such as complex formulation requirements,  potent powder handling issues, limited drug availability at the start of a development and the need to ensure that early stage manufacturing processes can be de-risked but also scaled easily to meet commercial volume requirements.  At 3P, we understand these challenges and therefore focus on developing technologies and machine solutions which will help customers manage the complete life-cycle of a product, with scalable production solutions to support development, clinical and commercial manufacturing needs. 

The R500/R1000 robotic powder filling platform is an excellent example of a machine technology that helps customers address all of the challenges highlighted above.

Solution:

Our innovative R500 & R1000 robotic capsule and device fillers include our patented Fill2Weight gravimetric powder filling system that accurately fills and weighs every single capsule or device. More accuracy means less product waste and reduced production costs. Thanks to our Fill2Weight technology, each batch can be accurately dispensed, as the machine can automatically account for powder properties’ changes between batches and even within the same batch. The R500 & R1000 are able to handle a wide variety of different powders with varying properties, such as spray-dried powders, pure APIs and lyophilised powders, with the potential to avoid the need to add excipients, which means the pre-clinical stage timescale can be significantly reduced as the product does not need to be reformulated for the filling process. As a direct consequence of this, companies using the R500/R1000 are able to reach the ‘First-In-Human’ milestone faster.

The R500/R1000  robotic capsule and device filler is fully automated, which completely eliminates the human element from the drug manufacturing process, reducing the risk of product contamination and providing better safety for both the drug product and the operator. Both machines are flexible and fully scalable, easily adapted to be integrated in lab, clinical and commercial production lines. With a multitude of add-ons and interchangeable modules, this technology can be adapted to perfectly match specific consumer needs.

Benefits:

In addition to the different technologies integrated within our R500 & R1000 machines, both robotic fillers provide an extensive list of key benefits to the customer. These include but are not limited to:

  • Full isolator option for containment, humidity and temperature control.
  • Gravimetric powder micro-dosing technology;   every dose is measured and recorded, improving product quality and maximising yield.
  • Flexibility: the Fill2Weight technology  is extremely versatile and can be adapted to handle a huge range of different powders, including those with poor flow, delicate particle properties and challenging morphology.  
  • The machine can fill both capsules (from sizes 00 to 4) and devices, enabled by change parts in conjunction with a powerful recipe management system.

  • Easily scalable for commercial, high-volume production. CMOs and CDMOs benefit from using this technology
  • Faster clinical scale production leading to faster ‘First-in-Human’ milestone achievement
  • Improved compliance – eliminating the human element implies reduced risk of contamination and errors (overfilling, underfilling, powder spillage or capsules/device damage)
  • Fully GMP and 21CFR11 compliant
  • Improved operator safety
  • Improved product quality and yield
  • Fills the range of standard capsule sizes from size 00 to 4.
  • Gentle bulk powder handling and feeding
  • Minimal operator intervention required;  Once loaded, the machine can run ‘lights-out’ for complete shifts and/or batches.

Example of a 10,000 capsule extended run, filling 12.5mg of powder into a size 3 capsule:

Dose: 12.5mg

Max: 13.6mg

Min: 11.4mg

Good dose: 99.3%

RSD: 2.13%

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