Points to Consider for Aseptic Processing: Part 1 provides revisions to PDA's Points to Consider for Aseptic Processing document issued in 2003. These revisions are based on the impact of knowledge gained in the industry as determined by a task force of subject matter experts.

The revision provides positions on current topics, best practices, and areas of clarification that are important to the manufacturing of quality sterile products. Many of the topics result directly from input provided by PDA members at conferences and meetings.

Primarily, the topics align with those addressed in the 2003 report, although the revision addresses some additional topics. Part 1 and Part 2 of this revision are meant to replace the 2003 Points to Consider for Aseptic Processing.

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Table of Contents:

1. Physical Environment
2. Environmental Monitoring
3. Validation
4. Personnel
5. Material Transfer
6. Cleaning, Disinfection and Sterilization
7. Critical Utilities