PDA EU00144 Freeze-Drying in Practice

Freeze drying, also termed lyophilization or sublimation drying, is a gentle drying technique. It has been widely used in the pharmaceutical industry for many years decades to improve the stability of medication both drug substances and drug products.

Biopharmaceuticals require an especially gentle manufacturing process due to their complex and thermosensitive molecular structure. In this regard, freeze-drying represents the method of choice for improving the storage stability of biopharmaceuticals, which may be insufficient in the liquid formulation.

While presently approximately 50% of these products are freeze-dried, a further increase in this percentage is to be expected in the coming years.

A freeze-drying process is divided into three stages: the freezing step process, primary drying, and secondary drying. The freeze-dryers necessary for this are complex, computer-controlled systems. The main components are a vacuum chamber with a vacuum pump and ports for attaching the product as well as the cooled condenser, where a deposit of the subliming steam from the product occurs on its surfaces.

Automated cleaning and sterilization units complete the range of functions. Production freeze-dryers are integrated into process lines and equipped with automatic loading and unloading systems to satisfy both aseptic requirements and higher product throughput while at the same time decreasing error rates.

You will be thoroughly familiar with the freeze-drying process. The structure and operating principle of freeze-dryers are introduced and the interaction of the different functional groups is explained. Moreover, guidance for developing a freeze-drying recipe is provided.

Emphasis is placed on technical support, calibration of the most important sensors, qualification of the system, and preventative maintenance. You will learn how to identify and remedy the most frequently occurring system malfunctions. Understanding the maintenance plan rounds off your skills of servicing a freeze-drying system.

Cleaning and sterilization requirements are discussed intensively and their technical application will be demonstrated on the freeze-dryer. Technical concepts are introduced for automatic loading and unloading.

Interactive training elements, exercises, and experiments in the laboratory and production areas constitute a large part of the course. After you have been familiarized with the theoretical background, you will carry out a freeze-drying process to completion under the guidance of experienced experts. The results are examined, and potential errors and their avoidance are discussed thoroughly. You will obtain insight into the procedures for cleaning and sterilization and will also carry out these processes yourself.

The practical character of the meeting is furthermore supported by the fact that you may pose questions from your everyday work, which will then be discussed collectively. You will receive advice from the experts and have the opportunity to exchange with the other course participants.

Who Should Attend

This training course is generated for operators of pharmaceutical freeze-drying systems. It particularly addresses employees in the areas of:

• Production
• Technology
• Qualification/Validation
• Quality Assurance who are responsible for the planning, purchasing, operation, usage, and qualification/validation of freeze drying systems.

Learning Objectives

You will be thoroughly familiar with the freeze-drying process. The structure and operating principle of freeze-dryers are introduced and the interaction of the different functional groups is explained.

Emphasis is placed on technical support, calibration of the most important sensors, qualification of the system, and preventative maintenance. You will learn how to identify and remedy the most frequently occurring system malfunctions. Understanding the maintenance plan rounds off your skills of servicing a freeze-drying system.

Cleaning and sterilization requirements are discussed intensively and their technical application will be demonstrated on the freeze-dryer. Technical concepts are introduced for automatic loading and unloading.

Interactive training elements, exercises, and experiments in the laboratory and production areas constitute a large part of the course. After you have been familiarized with the theoretical background, you will carry out a freeze-drying process to completion under the guidance of experienced experts. The results are examined, and potential errors and their avoidance are discussed thoroughly. You will obtain insight into the procedures for cleaning and sterilization and will also carry out these processes yourself.

The practical character of the meeting is furthermore supported by the fact that you may pose questions from your everyday work, which will then be discussed collectively. You will receive advice from the experts and have the opportunity to exchange with the other course participants.