Semi-Automated Capsule Filler
Pharma Equipment
- pharma equipment
- EXPLORE - Clinical scale
- Semi-Automated Capsule Filler
Semi-Automated Capsule Filler
The Semi-automated Capsule Filler is part of 3P innovation's Pharma Equipment Explore Range, offering the potential to simplify formulation by eliminating the need for additional ‘formulation for powder filling’ steps.
- Semi-automated
- Scalable, high-speed filling
- Fills spray-dried, pure API, blended, freeze-dried and biological powders
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.
The C500 can fill: capsules, reservoir device filling, single-use devices, blisters, vials, cartridges and syringes all on the same machine.
Machine features
- Rapid changeover
- Scalable, high-speed filling
- Fills spray-dried, pure API, blended, freeze-dried and biological powders
- 100% weight verification and recipe management system with 21CFR11 features compliant
- Semi-automated
- Up to 500 cph
- Mobile - easy to move between cleanroom and labs with a compact 1m x 1m footprint
- Fully GMP compliant
- Sterile manufacturing option
- No powder compaction and no particle shear
Highly flexible
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.
- Versatile and tolerant to variations in powder properties
- Easily scaled for commercial manufacture
- Infinitely variable dose weight without tooling change
- Options include a full range of containment and product transfer solutions from basic guarding to full isolator
Reduce pre-clinical timescales: Fast-track to Phase III
The Semi-Automated Capsule Filler Fill2Weight technology offers the potential to simplify formulation by eliminating the need for additional 'formulations 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 in human (FTIH) milestone.
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.
Precision Dosing for Potent Drugs
Confidently fill low dose weights including pure API or higher concentrations of API with no or limited excipient.
The C500'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.
Supporting Formulation Development
The C500's Fill2Weight system is designed to fill delicate, spray-dried and freeze-dried (lyophilised) powders without damaging powder particles. Fill2Weight only needs a few grams of powder to operate, so customers can benefit from using a production-representative filling process from the earliest stage of formulation development.
Sterile Manufacturing
The C500 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.
Real-time Process Control
The Fill2Weight system is dynamic, compensating for the unstable, changing nature of powders and variations between batches to provide 100% real-time process control.
The HMI records and indicates individual fill weights and highlights out-of-tolerance doses.
MACHINE SPECIFICATIONS | |
Capsule Formats | Hard gelatin/ HPMC capsule bodies Size 000 - 5 |
Containers | Vials 2R - 20R with stoppers and caps Cartridges and syringe |
Devices | Individual dose, MDPls and specials Custom tooling design available for filling, sealing and assembly |
Speed | Up to 500 capsules/containers* per hour *Dependent on device design, dose weight and closure method |
Dosing Parameters | Range: 2.5mg to 500mg at standard Accuracy: <3% RSD typical |
Weight Verification | 100% by weight, 10ug 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 to IBC |
Compaction | 0%, ideal for inhalation and reconstitution application |
Electronic Records | 100% of dose samples 21CFR11 as standard |
Supplies | Electrical: IEC 22 +/- 20V AC @ 50Hz (13A fuse) Pneumatics: 5.5 - 8.0 bar, 8mm push fit pipe |
Application | Formulation development Pre-clinical manufacturing Clinical production Commercial production |