Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators

Jun 2020
PDA Item Number

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

PDF Single user
Member Price
Nonmember Price
Government Price

Focusing on important regulatory and technical updates surrounding isolator design, validation, and operations for aseptic processing, this Points to Consider addresses two primary types of isolators - open and closed - and is intended to support identification and use of modern technology. It does not represent a standard or regulatory guidance.

It is organized by topics related to what to consider in designing and managing isolator systems, followed by relevant points to consider. Each point begins with a problem statement in the form of a question, representing issues or points needing clarification on the specific topic. Recommendations from subject matter experts are presented in response to each question, along with the rationale for the recommendations and references where available.

Learn about best practices and considerations and encourage further dialogue with industry, health authorities, and suppliers of technology and materials while taking into account the changes and needs of the modern, global, sterile healthcare product manufacturing industry.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 2.77 MB)

*To purchase licensing, please contact PDA at [email protected].

Table of Contents

Table of Contents:

Click here to download >>> Table of Contents
Topic 1: Isolator Design
Topic 2: Physical Environment
Topic 3: Personnel
Topic 4: Integrity Testing of Isolator and Gloves
Topic 5: Environmental Monitoring
Topic 6: Material Transport and Loading of Isolators
Topic 7: Cleaning, Disinfection, Decontamination: Cycle Development and Validation
Topic 8: Aseptic Process Simulations (APS)
Topic 9: Best Practices in Aseptic Operations