In 2003, PDA issued a Points to Consider (PtC) for Aseptic Processing document; however, there have been many updates in the industry in the 13 years since the original PtC document was published.

In an effort to address the impact of this gained knowledge, PDA set up a task force of experts to develop a revision to this important document. In January of 2015, PDA published a Part 1 revision, which focused on current topics, best practices and areas of clarification on environmental monitoring, material transfer, filter integrity testing and more.

The just-released Points to Consider for Aseptic Processing: Part 2 was created to address aseptic process simulation and validation, modern blow/fill/seal technology, RABS and isolators, cleaning, disinfection and sterilization and critical utilities.

These PtC documents are not standards or regulatory requirements; they are consensus-based best practice guidance documents developed within the subject matter expertise of PDA's membership to improve sterile healthcare products.

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Table of Contents:

1. Physical Environment
2. Environmental Monitoring and Control
3. Validation (Process Simulation)
4. Cleaning, Disinfection and Sterilization
5. Critical Utilities