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• Freezing – Filled vials are loaded at 5°C (shelf temperature) and the product freeze by reducingthe shelf temperature to -45°C (at 0.2°C/min). Then hold at -45 °C for a duration of not less than240 minutes.
• Annealing – After freezing, the product is subjected to heat annealing by increasing the shelftemperature to -15 °C (at 0.5°C/min). Then hold at -15°C for a duration of not less than 240minutes.
• Refreezing – Refreeze the product by reducing the shelf temperature to -45 °C (at 0.5°C/min).Hold at -45 °C for a duration of not less than 360 minutes.
• Cool the condenser and evacuate the chamber to not more than 100 mTorr throughout primarydrying by pyranic gauge.
• Primary Drying – Sublime the ice by adjusting the shelf temperature to -10°C (at 0.2°C/min)while maintaining chamber pressure at 100 mTorr. for a duration not less than 2520 min.
• Secondary Drying – Desorb bound water by increasing the shelf temperature to final secondarydrying temperature of 35°C (at 0.2°C/min), with an intermittent ramp at 0°C. Hold at 35°C fornot less than 600 minutes.
• Stoppering – At the completion of drying, aerate the chamber with sterile filtered nitrogen, untila pressure of 650 ± 50 Torr, and fully insert the stoppers into the vials by collapsing the shelves.
• Unload the stoppered vials and move the vials to the capping area.
