Pharma mini Implant Line

제조사  : 독일 Thermo Electron Karlsruhe GmbH

가    격  : 전화문의 [02-3143-2740]

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. 

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