Text Box: Historically freeze dryers controlled the Shelf Temperature and Chamber Pressure in an ‘open loop’ fashion. Adding product sensing provides feedback to shorten and optimize the freeze drying run. End of Freezing By measuring several product probes during the freezing process the system can determine if the vials are frozen. The freezing routine is automatically advanced to a final freeze step to ensure that all product is frozen, thus optimizing the freezing cycle. Eutectic Point For crystalline products, the eutectic point can be used to determine the vacuum level and shelf temperature to provide optimum freeze drying performance. If the Eutectic Point is not known, the system can measure it. End of Primary Drying Primary drying is typically the longest part of a freeze drying cycle and must continue until all the unbound water is removed. To optimize the primary drying phase of freeze drying one of several techniques can be used. 1. Product Temperature End of Primary Drying Setpoint The user enters an ‘end of primary drying’ product temperature (Tpe). When the product temperature average reaches (Tpe) the defined setpoint in the primary drying recipe, the program will automatically advance from the recipe to a predefined (3 step) finishing routine and then secondary drying. The finishing routine can be used to ensure that all vials have completed primary drying before entering secondary drying. If the finishing routine is not programmed, then the recipe jumps automatically to secondary drying. This feature is particularly useful for use with small lots of product. 2. Capacitance Manometer Differential Test (Capacitance manometer is required) The Pirani vacuum gauge measures relative vacuum and responds to the vapor present in the freeze dryer. The capacitance manometer indicates the absolute vacuum and is not affected by vapor pressure. When the two gauges reach within a predetermined level the primary drying process can be considered complete. The user enters a differential (mT). During the primary drying process, when the differential is met, the program jumps to a finishing sequence and then secondary drying. 3. Dew Point via Moisture Sensor (Moisture sensor is required) A moisture sensor may be used to respond to the residual moisture content of the product. The user enters a dew point (deg C) and when the product reaches this point, the program jumps to a finishing sequence and then to secondary drying. 4. Pressure Rise (Isolation valve is required) When the freeze drying chamber is isolated from the condenser and vacuum pump, the vapor pressure will force the vacuum to rise. With ice in the chamber the pressure will rise faster than without ice present, thus indicating that the product has not reached the end of drying. The user enters the test time, the acceptable pressure rise and how often to repeat the test during the primary drying recipe. The program will advance to secondary drying when the pre-set pressure rise rate is reached.

Opti-Dry™ Pro Freeze Drying Optimization Software

Software for R&D, Protocol Cycle

Development, Cycle Automation and

Optimization

Features:

· Eutectic Point Determination

· Product Temperature Feedback optimizes the recipe, both freezing and primary drying

· Primary Drying End Point Determination Methods

· Product Temp

· Capacitance Manometer Differential

· Dew Point

· Pressure Rise

· Automatic Cycles based on Product Critical           Temperature

Pressure Rise Test Screen

Opti-Dry™ Software

© 2006 MILLROCK TECHNOLOGY www.millrocktech.com

MILLROCK TECHNOLOGY, Inc

Kingston, NY 12401

845-339-5700

sales@millrocktech.com