Part of 3P innovation’s Pharma Equipment Discover range this Tamping Pin Dosator has been developed to fill capsules during early phase pharmaceutical formulation and to automatically produce early phase clinical batches.

• Increase laboratory capability and eliminate scale-up risk
• Minimise process uncertainty 
• Post-process dosing parameters

A key advantage of this Tamping Pin Dosator is that the small size of the powder bowl actively supports process understanding at a stage when quantities of the active ingredient, available for process optimisation, can be extremely limited. This significantly reduces the cost of studies into compaction and dissolution.

Increase laboratory capability and eliminate scale-up risk

This Tamping Pin Dosator is designed to fit on a bench or within a fume extraction envionment an yet replicates full scale commercial proccesses. Scale-up issues are eliminated by the flexible design uses, wither 3P’s or clients existing commerical pin sets (00 to 4).

It also operates with small amounts of active pharmaceutical ingredient, to match early stage formulation requirements. The system measures and records the force and position of each of the six tamping pins in real time together with dispensed weight to provide a “window” into the process. The ability to rapidly and cost effectively feedback represntative process data into the formulation process significantly increase labriatory capability, adding value and eliminating risk.

Minimise process uncertainty 

Specifically targeting capsule based formulations the Tamping Pin Dosator is designed to replicate a standard commerical process and so can be used to screen formulations during the production cycle and before new powdered ingredients are run through existing production facilities.

Since the Tamping Pin Dosator records and permanently stores critical process parameters, quality becnhmarks can be easily established against which reject criteria can be set. The ability to screen supplier products before issues are indentified in-production can save signifiant equipment down time, removes uncertainties and strengthens in-house quality and supplier control procedures.

Post-process dosing parameters

The Tamping Pin Dosator is provided with data logging capabilities that provides users with details of the tamping pin displacement and compression forces assocaited with each stage of the pwder slug’s formation. The data files can be exported to a number of common packages, such that key process metrics can b established. The data is also presented graphically. Such data is critcal during dissolution charactisation assessments.

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

• • 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.