AMS Labo

THERMOFISHER SCIENTIFIC

Pharma mini Implant Line

UGS 553-6060 Catégorie

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.

UGS 553-6060 Catégorie

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 0.5mm and 2.0mm; 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

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