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Course description

Key Topics Covered:

Who Should Attend?

Learning Outcomes

Background

The definition of freeze drying and some of the advantages of freeze drying as a storage technique and the potential disadvantages of the technique are defined. Likely freeze drying candidates with reference to the pharmaceutical industry are identified

The Freeze Drying Cycle

An overview of water physics including the triple point and phase diagrams. The ancilliary activities within a complete freeze drying cycle, in addition to the three stages (freezing, primary and secondary drying) will be described and discussed within the ancilliary activities section.

Freezing

The purpose and importance of freezing and how solutions freeze including homogenous and heterogeneous freezing will be defined. The differences between eutectic crystallisations and glass transitions and their relationship to collapse and melting. How to measure solidification temperatures including the techniques of the freeze drying microscope, resistance, DSC and DTA measurements. How to control ice crystal structure to enable efficient freeze drying.

Primary Drying

The freeze drying interface and the progression of drying. The driving force of freeze drying due to differing vapour pressure in the different parts of the freeze dryer. How to control drying rates for optimal freeze drying cycles. How to measure the progress of the freeze drying cycles including techniques for end point determination.

Secondary Drying

The removal of absorbed moisture to attain low final moisture levels giving long term storage stability. How to control and measure final moisture levels.

Ancillary activities

The ancilliary activities in a commercial freeze drying cycles are described in detail including

  • Stoppering
  • Backfilling
  • Aeration
  • Loading and unloading
  • Sterilisation
  • Defrosting
  • CIP
  • Filter integrity testing.

Problem Areas

The potential problem areas, and how to avoid collapse, melting, ablation and high final moistures are discussed.

Practical aspects

Practical aspects of freeze dryer operation are discussed including probe placement, leak testing and chart interpretation

The Freeze Dryer

The component parts and systems within a freeze dryer are considered including

    • Refrigeration
    • Shelf thermoregulation
    • Stoppering
    • Vacuum system
    • Control system
    • Data recording
    • Steam sterilisation system
    • CIP system

PAT

A review of the process analytical techniques (PAT) available to the freeze drying technologist, the background to the technique and its advantages

Formulation

The basics of formulation are considered including the use of buffers, sugars and bulking agents. The damage to biomolecules caused by freezing effects are discussed and how to avoid damage by the use of cryoprotective agents. The avoidance of chaotropic excipients

Practical Freeze Drying in Industry

The pharmaceutical industry operates in a tight regulatory environment. GMP is defined with the regulatory expectations of FDA, EMEA and WHO.

Practical aspects including

    • Validation
    • Sterile Manufacture
    • Manufacturing areas
    • Batch Size and capacity
    • Scheduling

Are also discussed

Questions/ Discussion.

• Formulation
• Product Modelling
• Plant Operations
• Medical Devices
• Quality control and Assurance
• Product and Process R & D
• Production, engineering
• Sterile Manufacturing
• Process Technicians
• Plant Leaders
• Operation Technicians
• Biotechologist and Microbiologist
• Pharmacist and Chemist

• Pharmaceutical
• Biotechnology
• Biomedical engineering
• Diagnostics
• Food Industries

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Section 1
Final Quiz