Produce high-quality, injectable drug delivery systems with the Thermo Scientific™ Pharma mini Implant Line. This automated end-to-end solution meets cGMP and FDA requirements. Accurate dosing of pre-blended material enters the extruder, which moves material through a die to produce a filament. A closed-loop filament control system ensures that the implant strand has minimal diameter variability. The strand is cut to the required implant diameter and length. Out-of-specification implants are automatically discarded, assuring 100% quality.
Description
The Pharma mini Implant Line offers a complete solution for developing and producing injectable drug delivery systems. High-quality components and precise automation with integrated Quality Control and documentation assures consistent drug implant manufacturing.
Pharma mini Implant Line Advantages
- Hermetically sealed material container for maximum operator and product safety
- High accuracy gravimetric feeding (± 0.5%, depending on material)
- Reproducible and stable extrusion process up to 100 g/h
- Accurate diameter control adjustable in the range of 0.5 mm and 2.0 mm; precision of final product is ± 0.005% to 0.05% (depending on physical parameters of the compound used)
- Exact cutting of implant strand into specified length
- Automated sorting of in-spec and out-of-spec product for 100% quality assurance
- Integrated software control system for process monitoring, documentation and displaying all relevant system and process data
- 21 CFR part 11 compliant Batch Report and Audit Trail
Pharma mini Implant Line Components
- Container with containment valve
- Gravimetric feeder with feeder screws and feeder stand
- Pharma mini HME micro compounder with co- or counter-rotating screws
- Filament diameter control and cutting unit with sorting unit
- PLC with integration of all Pharma mini implant line instruments
- Chiller unit