Course 1 : Lyophilization Basics for Pharmaceuticals: History, Scientific Principles, Cycles and Formulations
Course 2 : Lyophilization Basics for Pharmaceuticals: Unit operations, equipment, instrumentation, and performance

An Overview of Lyophilization Pharmaceutical Course

This Lyophilization Pharmaceutical Course is sure to act as an outline for freeze-drying of pharmacological parenteral products. Many medicine substances necessitate the extra protection that lyophilization usually comes with, and the preparation of the liquid drug product must be designed to enhance the efficiency of the completely dried product. This course will cover multiple objectives right from how lyophilization functions to changing a liquid drug product into a dried, more-stable powder. Cycle and preparation design will be elucidated, along with the methodical values that are at play.

This course will also cover manufacturing operations for freeze dried pharmaceuticals, as well as instruct attendees about the equipment, systems, subsystems, and instrumentation utilized in a commercial lyophilizer. Performance limitations will be described, as well as techniques to optimize equipment capability and freeze dry cycles.  


Reasons for You To Attend Lyophilization Pharmaceutical Course:

To study the process and reasons for formulating and designing lyophilization cycles for drugs that will gain an advantage from the freeze-drying procedure


Learning Objectives

  • Definition of freeze-drying or Lyophilization
  • Classify perfect features of a freeze-dried product
  • Regulate when freeze-drying is essential
  • Phases of the lyo cycle, and the methodical principles that drive each stage
  • Framing drug products for fruitful freeze-drying
  • Analytical tools used to aid in the formulation and cycle development
  • Understanding of manufacturing process
  • Identification of all systems and subsystems within a freeze dryer
  • Proper use of freeze dryer instrumentation
  • Understanding and examples of Process Analytical Technologies
  • Characterization of process control limitations
  • Use of design space for primary and secondary drying

Agenda Course 01

Section 1: History and background

  • Definition of freeze-drying or Lyophilization, history, and commonly freeze-dried materials
  • Anticipated freeze-dried features
  • Rewards/ advantages and limitations of freeze-drying
  • Procedure overview

Section 2: Physical, chemical, and engineering principles

  • Vapor pressure
  • Sublimation and the phase diagram of water
  • The heat of sublimation of ice
  • Rate processes in freeze drying – heat transfer and mass transfer
  • States of matter – crystalline and amorphous

Section 3: Lyo-cycle phases

  • Freezing (with optional annealing)
  • Primary drying (sublimation of water vapor)
  • Secondary drying (diffusion and evaporation of water that did not freeze as ice)

Section 4: Lyo formulations

  • Excipients for small and large molecules

Section 5: Quality product attributes

  • General and specific to freeze-dried products
  • Influence of collapse and eutectic melting

Agenda Course 02

Unit operations for freeze-dried pharmaceuticals

  • Formulation
  • Component prep
  • Filling
  • Lyo / capping
  • Inspection
  • Labeling and packaging

Freeze-Drying equipment

  • Basic components 
  • Systems and subsystems
  • Sequence of operations

Instrumentation

  • Temperature and pressure measurements
  • Process Analytical Technology (pressure, moisture, gas flow, TDLAS, FM spectroscopy, NIR)

Performance

  • Sources for process control imprecision (variables affecting heat and mass transfer)
  • Choked flow
  • Measurement of equipment capability
  • Freezing Optimization via controlled nucleation
  • Cycle optimization via design spaces for primary and secondary drying

Who Will Benefit

  • Professionals in Quality Control
  •  Quality Assurance
  • Validation
  • R&D Groups
  • Biochemists
  • Pilot Plant Operators
  • Chemical Engineers
  • Production Supervisors
  • Chemists
  • Equipment Maintenance
  • Mechanical Engineers

The course will also benefit those in other departments who find lyophilization among their responsibilities.

Faculty Lisa Hardwick Thompson

Faculty Lisa Hardwick Thompson 

Pharmaceutical Lyophilization Expert at Lyo Blackboard LLC

Nashville, Indiana, United States

Lisa Hardwick Thompson is a pharmaceutical technology consultant and educator with quality, regulatory, product/process development, and technical management experience at Cook Medical, Baxter, Catalent, and start-up businesses. During her career based in the pharmaceutical CMO sector, her expertise has been dedicated to the creation and/or transfer of clinical and commercial formulations and processes, specifically focused on lyophilized parenteral drug products. Her current role at Lyo Blackboard is devoted to consultation and education in the field of lyophilization.

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