Precision Calibration and Cutting Machine for Pharmaceutical Implants
New drug delivery systems, such as ocular implants or subcutaneous implants, require precise production with strict tolerances for the diameter and length of polymer filaments. The post-extrusion CaliCut system is the next generation of instruments for precise calibration of polymer filaments and their cutting into well-defined implants. Adapted to a variety of polymer formulations and application fields, the post-extrusion CaliCut system is a highly modular instrument that can be adjusted to meet a wide range of product specifications.
High Precision
The compact post-extrusion CaliCut system is placed right next to the extruder die, so the polymer filament can be directly guided through a 1D laser diameter gauge and onto the conveyor without major cooling. Based on the laser measurement, the conveyor speed is adjusted to pull the filament, allowing the diameter to be adjusted within defined tolerances. Depending on the extruder die, the CaliCut system can handle a nominal filament diameter of 0.2 mm to 6 mm. The nominal length of an implant can be set from 1 mm to 200 mm.
Maximum Flexibility
Before a filament enters the cutting section of the instrument, the length of the conveyor ensures sufficient cooling of the filament, allowing for cutting with maximum precision. To meet a wide range of polymer formulations and throughput needs, the instrument is available with conveyor lengths of 350 mm, 700 mm, or even 1200 mm. Cooling can be accelerated with compressed air.
The cutting of an implant is a crucial step, and smooth cutting surfaces depend greatly on the polymer formulation and the cutting method applied. Therefore, the post-extrusion CaliCut system can be equipped with two different cutting mechanisms: a rotary blade and a linear blade. Both cutters can be parameterized to ensure the best possible cut for all implant materials. Adjustment possibilities for different cutting cone geometries enable the realization of cutting solutions for various product qualities. As a production device, the CaliCut system is suitable for up to 600 cuts/min.
Pharmaceutical Application
The computer control of the CaliCut system is housed in a robust stainless steel enclosure that complies with GMP guidelines. It can be placed on or next to the instrument to best fit the production line layout. The user interface is easy to use, provides full access to all machine parameters, and monitors the analytical performance with a live diagram of the measured filament diameter. The software offers different user levels with customizable access rights, secure data export, and audit trail support for 21 CFR Part 11 compliance. The post-extrusion CaliCut system comes with comprehensive IQ/OQ documentation.
With its great flexibility and interchangeable parts, the CaliCut system can be configured for use in research and development as well as in commercial production.
