The Crystal® Technology, based on the Ready-to-Fill Closed Vial, enables safer and easier operations as it eliminates exposure to contamination and particles, and facilitates complete operations: from filling to the use by healthcare professionals.
The main advantages of the Crystal® Technology are:
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Higher sterility assurance level and reduced particle contamination:
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Vials and stoppers molded and directly closed in a ISO 5 clean room, followed by gamma irradiation for sterilization, ensure clean and sterile Ready-to-Fill Closed Vial;
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Vial inside never exposed during the complete process as they remain closed, so each vial behave as an isolator;
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Sterility assurance of the piercing area during storage maintained by the cap;
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Meets latest authorities’ requirement for Good Manufacturing Practices.
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Elimination of the most complex steps of glass vial filling to simplify operations:
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No vial/stopper washing, no siliconization, no sterilization, no depyrogenization, no cooling tunnel where open vials are exposed.
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No stoppering, easy high-speed capping
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No need for water for injection on the filling line
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Reduced QA/QC at validation and on regular basis
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Safer supply chain:
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No spillage outside container during filling;
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In line coding possible and ready for RFID identification and tracking;
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Closed sterile container resistant to damages;
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Closed Vial preferred by end-users:
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Reduction of investment and operating expenses:
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Reduced clean room space for the equipment (up to a factor three);
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Residual volume in the vial reduced by stopper design can lead to lower overfill required;
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Reduction of vial loss by breakage;
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Less operators and less QA/QC work.