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Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs. Generating very large frozen particles due to the initial freezing process can cause the sedimentation rate to go way up causing a much longer cycle than effective design of the process can accomplish making the process more cost effective and higher quality.
Why should you Attend: The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. Principles and concepts presented are later used to discuss real world pracdtical applications. The long term training sessions include participants in development, operations, engineering, technical services, quality, validation, and regulatory affairs. Brief on-line training addresses critical aspects of freeze drying to ensure compliance, validation and minimization of patient risk based on the development of the product proven to have been during the clinical trials before the product was transferred into commercial scale operations.
Areas Covered in the Session:
Who Will Benefit:
- Essentially a brief discussion about each of the Critical Aspects and related affects of Variables
- Lyophilization 101 – Comprehension on each step of the Freeze Drying/Lyophilization Process
- Understanding why various steps of the process become more advantageous and cost effective
- Sublimation Rate Variability
- Heat Transfer
- Loss of Protein Activity
- Freezing Affects on Primary Drying
- Optimization of Primary Drying and Proof of the effectiveness of Secondary Drying
- Effects of Freezing Method and Excipients on Protein Surface
- Influence of Packing Density and the container selection
- Residual Moisture Regulatory Considerations by the FDA
- Compliance Manager
- Process Engineer
- Validation Manager
- Regulatory Manager
Jerry Dalfors has extensive (40 years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.
He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.
He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training.
Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry.