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PDA PTC Isolators-2020
Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
This document is designed to communicate best practices and considerations and to encourage further dialog 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. In 2001, PDA issued Technical Report No. 34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products. Since then, much has been learned by industry, and several important regulatory guidelines, scientific articles, and conference presentations have been published. In an effort to address the impact of the knowledge gained, this task force was established to focus on important regulatory and technology updates impacting isolator design, validation, and operations for aseptic processing. Two primary types of isolators—open and closed—will be addressed in this Points to Consider (PtC) document (see Glossary). Additional related topics, such as sterility testing isolators and containment isolators, will be discussed in a separate PtC document in the future.
Parenteral Drug Association [pda]