Application and Insights for Lyophilization of Parenteral Products (single user digital version)

Apr 2009
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This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 1

Lyophilization has been used since the mid 1930s (Flosdorf et al., 1938) with the intent of preserving health care products that are not stable in a liquid ready-to-use form in the presence of water. The limited stability is due to degradation involving hydrolysis reactions with water. Preservation for adequate long term storage for such parenteral products is achieved by converting the product from the liquid to the dried state. In preparation of a solid sterile product for administration to a patient, a diluent, often water for Injection (WFI), is added to return the product to a liquid, suitable for parenteral administration. Though the application of this technology was first applied to plasma and antibiotic parenteral products, lyophilized parenterals continue to include antibiotics, human derived plasma products, vaccines, now encompassing entities such as recombinant proteins, liposomes and nanoparticles.

The scientific basis of this technology is rooted in fundamental principles of basic chemistry and biochemistry, physics and the applied physical sciences. This presentation on the subject is designed to provide an overview of the unique aspects and principles applied to producing diverse types of parenteral products.

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Format: Digital PDF (1 file - 3.20 MB)

Table of Contents

Table of Contents:

  • Introduction
  • Applications of Lyophilization in Sterile Product Processing
  • Unique Requirements of Lyophilized Products
  • Characteristics of Lyophilized Parenterals
  • Processing Steps
  • Lyophilization Process Overview
  • Freezing
  • Primary Drying
  • Secondary Drying
  • Applications of Basic Principles
  • Methods of Analysis
  • Importance of the Phase Transition Temperature
  • Examples of Freeze Drying Cycles
  • Influences of Aseptic Process in Manufacturing
  • Process Control Parameters
  • Lyophilization Equipment
  • References
  • About the Authors

    About the Authors

    Edward H. Trappler
    is founder and president of Lyophilization Technology, Inc. a contract research, technical services and clinical material manufacturing firm dedicated to freeze drying. He has over 30 years experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production. Ed has authored and presented numerous papers and courses in freeze drying in the United States, Europe, Japan and China. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Validation Task Force. He is also a member of the American Association of Pharmaceutical Scientists, American Institute of Chemical Engineering, and International Society of Pharmaceutical Engineers.