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Exhibit 12: SX-310-RDL for feeding, filling, and closing of vials with RayDyLyo® caps
NJM is the exclusive distributor for Dara Pharmaceutical Equipment in the USA and Canada.
Dara Pharmaceutical designs, develops, and manufactures technologically advanced equipment for washing, sterilizing, filling, freeze-drying, and closing vials, bottles, syringes, cartridges, and IV Bags in sterile conditions.
The SX-310-RDL fills vials from 0.1 ÷ 250 ml with 100% IPC at output up to 7,200 uph.
Options
- Washing unit and sterilization tunnel for vials supplied in bulk.
- 100% checkweighing.
- Gas flushing before, during or after the filling process.
- Dosing system for CIP / SIP conditions.
- Vacuum-assisted insertion of stoppers to reduce the presence of oxygen in headspace.
- Automatic rejection of defective vials.
- SCADA software to process data acquisition in accor-dance with FDA 21CFR Part 11.
- Monitoring and particle counting.
- Laminar flow / RABS / Isolator.
- IQ / OQ validation package.
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