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Machines

Powder Filling

R500 & R1000

Reach 'First-in-Human' milestones faster.  Compressing clinical development timescales and reducing costs, the R500/1000 provides a highly flexible and scalable powder filling capability for capsules, devices and other containers.  

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. Fully automated, GMP compliant and suitable for sterile manufacture.

Benefits summary:

  • Fill capsules, containers and devices on the same machine
  • Rapid changeover
  • Scalable, high-speed filling
  • Fills spray-dried, pure API, blended, freeze-dried and biological powders
  • 500 - 1000 cph on same machine footprint
  • 100% weight verification and 21CFR11 compliant
  • Fully automated
  • Mobile: easy to move between clean room and labs
  • Compact: 1m x 1m footprint
  • Fully GMP compliant
  • Sterile manufacturing option

How the R500/R1000 adds value:

  • Reduce Pre-clinical Timescales: Fast-track to Phase III

The R500 and R1000’s Fill2Weight technology offers the potential to simplify formulation by eliminating the need for additional ‘formulation for filling’ steps. Its ability to handle and fill challenging formulations, such as cohesive, adhesive, light and fluffy powders, reduces development time and associated costs and helps accelerate achievement of clinical Phase I and the first time in human (FTIH) milestone.
Not only does the R500/R1000 support faster achievement of Phase I, the fact that reduced formulation for filling is required may also mean that costly and time-consuming stability trials necessary to evaluate these additional processes are reduced accordingly.
The system is highly flexible — system parameters can be quickly and easily adjusted to suit different powders, varying environments and varying bulk powder properties. Resulting ‘recipes’ can be stored and can be quickly called up for future batches.

  • Sterile Manufacturing

The R500/R1000 is designed for sterile filling and can withstand hydrogen peroxide vapour (HPV) sterilisation as well as Wash in Place (WIP) and Clean in Place (CIP) processes with a variety of cleaning agents. 3P can provide full containment and environmental solutions to meet specific needs.

  • Precision Dosing for Potent Drugs

Confidently fill low dose weights including pure API or higher concentrations of API with no or limited excipient. The R500/R1000’s Fill2Weight system is designed to meet the challenges of low dose and potent drug handling and provides a versatile tool to support next-generation powders and formulations of the future.

  • Biological Drug Development

The R500/R1000’s Fill2Weight system is designed to handle and fill delicate, spray-dried and freeze-dried (lyophilised) powders without damaging powder particles. The technology also offers the opportunity for pharma manufacturers to fill tray (or bulk) lyophilised powders to reduce the overall costs associated with in-vial lyophilisation, opening up a whole new world of choice with regard to container or device type.

  • Real-time Process Control

The R500 and R1000 machines are fully automated, requiring minimal operator intervention. The Fill2Weight system incorporated in R500/R1000 is dynamic, compensating for the unstable, changing nature of powders and variations between batches to provide 100% real-time process control.

                                                      TECHNICAL DETAILS
Capsule formats Hard gelatin/HPMC capsule bodies
Sizes 000 - 5
Containers Vials 2R - 20R with stoppers and caps
Cartridges and syringes
Devices Individual dose, mDPIs and specials
Custom tooling design available for filling, sealing and assembly
Output R500: Up to 500 capsules/devices* per hour
R1000: Up to 1000 capsules/devices* per hour
* Dependent on device design, dose weight and closure method
Dosing parameters Range: 2.5mg to 500mg as standard
Accuracy: <3% RSD typical
Weight Verification 100% by weight, 10μg resolution
Powder Types / Capability Cohesive and non-cohesive without modification
Self learning algorithms adjust to individual powders and
environmental conditions
Bulk Powder Feed Options Manual top-up
Cross-feed from bag or IBC
Rotary, auger or vibratory feed from bag or IBC
Compaction 0%, ideal for inhalation and reconstitution applications
Electronic records 100% of dosed samples
21CFR11 as standard
Supplies Electrical: IEC 220+/-20V [email protected] (13A fuse)
Pneumatics: 5.5 - 8.0 bar, 8mm push fit pipe
Applications Formulation development
Pre-clinical manufacturing
Clinical production
Commercial production

 

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