Hudson Valley Lyomac
  • Freeze Dryers
    • Stratus MP3® Large Freeze Dryer
    • Trilogy® Series Freeze Dryer
    • Trident® Series Freeze Dryer
    • Futura® Series Freeze Dryer
    • BT-1000 ® Lab Benchtop Freeze Dryer
    • Industrial Freeze Dryers
  • Pharmaceutical
    • COVID-19
  • Laboratory
  • Dual Condenser
  • TESTIMONIALS
  • About Us
    • WORK WITH US
  • Contact
    • Request a Quote
  • Quality In Freeze Drying
  • Quantifying Vial Capping Process - Webinar
  • Complex Injectables - Webinar
  • Deuterium Exchange - Webinar
  • Continuous Lyophilization - Webinar
  • Lyophilized Drug Appearances
  • Refurbished Freeze Dryers
  • Freeze Dryer Size Calculators
  • Legal
Picture
Lyophilized Drug Cake Appearance: What is acceptable? - Patel, Sajal

Download Link Here

Abstract:

Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophilized drug product. However, “sometimes” a non-ideal cake appearance has no impact on product quality and is an inherent characteristic of the product (due to formulation, drug product presentation, and freeze-drying process). This commentary provides a summary of challenges related to visual appearance testing of freeze-dried products, particularly on how to judge the criticality of cake appearance. Furthermore, a harmonized nomenclature and description for variations in cake appearance from the ideal expectation of uniform and elegant is provided, including representative images. Finally, a science and risk-based approach is discussed on establishing acceptance criteria for cake appearance.
Request Lyophilizer Pricing or Information

Ordering and Technical Information

Hudson Valley Lyomac maintains a staff of qualified Field Service Engineers that provide technical assistance for the installation, commissioning, repair, and maintenance of  Hudson Valley Lyomac freeze-dryers. Our technical support centers are located in Europe and the US, as well as in key regional Customer Centers worldwide. 
CONTACT LYOMAC
Need Help? 

Have a question? Need Our Assistance?
Email: sales@hudsonvalleylyomac.com
Phone: 518-828-2180 / 800-836-0744 

​Mailing Address
Hudson Valley/Lyomac
793 Route 66
Hudson, NY 12534 USA

  • Freeze Dryers
    • Stratus MP3® Large Freeze Dryer
    • Trilogy® Series Freeze Dryer
    • Trident® Series Freeze Dryer
    • Futura® Series Freeze Dryer
    • BT-1000 ® Lab Benchtop Freeze Dryer
    • Industrial Freeze Dryers
  • Pharmaceutical
    • COVID-19
  • Laboratory
  • Dual Condenser
  • TESTIMONIALS
  • About Us
    • WORK WITH US
  • Contact
    • Request a Quote
  • Quality In Freeze Drying
  • Quantifying Vial Capping Process - Webinar
  • Complex Injectables - Webinar
  • Deuterium Exchange - Webinar
  • Continuous Lyophilization - Webinar
  • Lyophilized Drug Appearances
  • Refurbished Freeze Dryers
  • Freeze Dryer Size Calculators
  • Legal