ComplianceOnline

Lyophilization Technology

Instructor: Jerry Dalfors
Product ID: 704028
  • Duration: 80 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.

Why Should You Attend:

The fundamental principles and technology are coupled with practical aspects of lyophilization in this training program. The principles and concepts presented will form the basis to discuss real world practical applications. The webinar will address 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 Webinar:

  • 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 effects 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

Who Will Benefit:

  • Development
  • Operations
  • Engineering
  • Technical services
  • Quality
  • Validation
  • Regulatory affairs

Instructor Profile:

Mr. Jerry Dalfors has extensive (40+ years) business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including lyophilized 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. Mr. Dalfors is considered an expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.

Topic Background:

Lyophilization, commonly referred to as freeze drying, is the process of removing water from a product by sublimation and desorbtion. This process is performed in lyophilization equipment which consists of a drying chamber with temperature controlled shelves, a condenser to trap water removed from the product, a cooling system to supply refrigerant to the shelves and condenser, and a vacuum system to reduce the pressure in the chamber and condenser to facilitate the drying process. Lyophilizers can be supplied in a wide variety of sizes and configurations and can be equipped with options that allow system controls to range from fully manual to completely automated.

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 than 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.

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