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.We are well known high quality capsule filling machine supplier in India since last 10+ years.
The R500/R1000 capsule filling machine range provides the opportunity to reduce or eliminate ‘formulation for filling’ steps in 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, micronized, blended and bulk lyophilized powders. Fully automated, GMP compliant and suitable for sterile manufacture.
Benefits summary:
Fill capsules, containers and devices on the same machine
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- 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 the 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. The 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 vapor (HPV) sterilization 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 (lyophilized) powders without damaging powder particles. The technology also offers the opportunity for pharma manufacturers to fill tray (or bulk) lyophilized powders to reduce the overall costs associated with in-vial lyophilization, opening up a whole new world of choice with regard to a 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.
