Accelerating Freeze-Drying: From Model to Production of a Semi-Continuous Aseptic Spray Freeze-Dryer

Accelerating Freeze-Drying: From Model to Production of a Semi-Continuous Aseptic Spray Freeze-Dryer

04/17/2018, 10:30 AM - 11:15 AM

Technical Conference Stage 3, Booth 1376, Exhibit Hall

Language:
English

Freeze drying has traditionally been a batch process making it both, time consuming and energy intensive (Rambhatla et al., 2003; Liu et al., 2008). While the use of new process analytical technology has aided in- process understanding, the design of equipment is still based largely on legacy designs adapted for new customer requirements. In the conventional approach to freeze-drying, the product is placed in a containment directly on the shelf. The drying rate is controlled by setting the shelf temperature and chamber pressure in the product chamber. (Nail, 1980) identified poor thermal contact between the shelf and the vial as the rate limiting resistance to heat transfer. Moreover, the drying rate in such a configuration is a function of the coldest front in the product volume, the sublimation front. Recent findings (Ganguly et al., 2013) have demonstrated the importance of radiation in the low-pressure environment. With such findings, it becomes apparent that even though the process understanding has improved in leaps and bounds, its application to designing an optimum process is far removed. Thus, there is a need to re-think the heat and mass transfer for making the process more efficient. The current work focuses on developing a robust yet gentle aseptic process for freeze drying with an eye toward achieving high throughput/ high cycle efficiency. Understanding the freezing and drying behavior are critical to designing a spray freeze-dried process with uniform product characteristics. Here we utilize a high-speed camera augmented with image processing techniques to first understand the product spray characteristics. The drying behavior is then characterized using both, physics based models and measurements. In addition, the final presentation will discuss product characterization using scanning electron microscopy and optical micrographs for product uniformity and reconstitution times with the overarching goal of comparing the process with tradition freeze drying techniques. Finally, the authors will cover the design, build and manufacture of an aseptic spray freeze dryer. REFERENCES • Ganguly, A., Nail, S.L., and Alexeenko, A. "Experimental Determination of the Key Heat Transfer Mechanisms in Pharmaceutical Freeze Drying", J. Pharm. Sci., 102(5), pp.1610-1625, 2013 • Liu, Y., Zhao, Y. and Feng, X. Exergy analysis for a freeze-drying process. Appl. Thermal Engr., 28:675–690, 2008 • Nail, S.L. The effect of chamber pressure on heat transfer in the freeze drying of parenteral solutions. J. Parenteral Drug Assoc., 34:358–368, 1980 • Rambhatla, S. and Pikal, M.J., "Heat and Mass Transfer Scale-up Issues during Freeze-drying: I. Atypical Radiation and the Edge Vial Effect", AAPS PharmSciTech., 4(2): 14, 2003

Contributors

  • Arnab Ganguly

    Speaker

    Technology Manager

    IMA Life

    Arnab received a PhD in the School of Aeronautics & Astronautics at Purdue University in 2014 with a focus on modeling low-pressure water-vapor flows...

  • Frank DeMarco

    Speaker

    Product Manager, Freeze Drying

    IMA Life

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Market outlook for need of spray freeze drying 2. What does the process involve 3. Design, build and manufacture of an aseptic spray freeze-dryer

Categories

  1. Track
    Manufacturing Efficiencies & Improvements

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