Lyophilization of parenterals

Course Details

Module length 
1 Day
Learning tools 
Presentations, Lectures, Case Studies, Discussion, Question & Answers session


Target audience 
Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance


Theoretical bases
Critical Process parameters
Equipment & Process description
Cycle Development
Industrial production
EU-Annex 1 revision contents
Economics of the process
Equipment Qualification and Process Validation

Regulatory & technical references

  • EU GMP Annex 1: “Manufacture of sterile medicinal products”
  • FDA - Guide to inspection of Lyophilization of parenteral
  • Development of an Efficient Single-Step Freeze Drying Cycle for Protein Formulation (Beyong S. Chang and Norman Fisher) - Pharmaceutical Research, Vol. 12 No.6, 1995
  • A Design Space Approach to Freeze Drying Cycle Development (Biopharma Solution, April 2016)
  • Observation and Implication of Sonic Water Vapor Flow during Freeze Drying (American Pharmaceutical Review, 2018)
  • Lyophilization Process Design Space (Sajal M. Patel, Michael J. Pikal), Journal of Pharmaceutical Sciences 102: 3883-3887, 2013
  • Freeze Drying (Peter Haseley and George-Wilhelm Oetjen), WILEY-VCH 201
  • Choked Flow and Importance of Mach I in Freeze Drying Process Design (Sajal M. Patel, Swetaprovo Chandhuri, Michael J. Pikal), Chemical Engineering Sciences 65 (2010) 5716-5727)
  • Freeze Drying of Pharmaceuticals and Biopharmaceuticals - Principles and Practice (Felix Franks in association with Tony Auffret), The Royal Society of Chemistry 2007
  • Freeze Drying/Lyophilization of Pharmaceuticals and Biologicals Products (Louis Rey and Joan C. May), Drug and Pharmaceutical Science Volume 206
  • Excipients used in lyophilization of small molecules (Ankit Baheti, Lokesh Kumar, Arvind K. Bansal), J. Excipients and Food Chem. 1 (1) 2010
  • Lyophilization Process Design Space , (Sajal Manubhai Patel , Michael J. Pikal ) Published online 14 August 2013 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/jps.237 
  • Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice (Xialoin (Charlie) Tang and Michael J. Pikal), Pharmaceutical Research, Vol. 21, No. 2, February 2004
  • European Journal of Pharmaceutics and Biopharmaceutics 85 (2013) 214–222.
  • Controlled ice nucleation in the field of freeze-drying: Fundamentals and technology review R. Geidobler, G. Winter. AAPS PharmSciTech, Vol. 10, No. 4, December 2009 (# 2009) DOI: 10.1208/s12249-009-9338-7
  • Reduced Pressure Ice Fog Technique for Controlled Ice Nucleation during Freeze-Drying Sajal M. Patel, 1 Chandan Bhugra, 2 and Michael J. Pikal 1,3

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