Developing a good quality aseptic program at your facility may appear to be a daunting enterprise. Regulations are tightening, and the ability to run an aseptic operation in a quality manner while maintaining efficiency is often looked upon as difficult. However, utilization of effective quality practices can actually provide an appreciable improvement in efficiency as well. This session will discuss the basic elements of a high quality aseptic program. The discussions will include a review of efficient batch record generation, facility disinfection, gowning, autoclaving, and cleanroom behavior. Attendance at this seminar will inform the audience on high quality and effective ways to perform each of the following:

• How to create good, clear batch records, and their importance to the quality process
• How to train for the gowning process
• How to train for clean room behavior
• How to efficiently sterilize disinfection tools and materials
• How to efficiently sterilize machine parts
• How to develop the zero-failure mind set

Insight into the lyophilization process is rooted in understanding the basic concepts, underlying theories, as well as mechanism for each process step. Using an example of a lyophilization cycle, discussions will entail an overview of the parameters and conditions for freezing, primary and secondary drying along with a focus on the underlying principles. These discussions will address each step of the process separately as well as integrated parts of the process. Real world examples to illustrate the concepts will be included. This workshop is designed to introduce the fundamental aspects of lyophilization and provide an understanding of the critical aspects. The information to be presented is intended as an introduction for those having a beginning interest as well as a refresher for the more experienced. An informal and interactive forum, attendees will be able to participate in the discussions on:

• Principles and mechanism

• Critical and key process parameters
• Interdependence of the process steps
• Influences of the process on the product
• Product attributes - formulation and process factors