ISPE Good Practice Guide: Process Gases PDF

The ISPE Good Practice Guide: Process Gases aims to define current good practices within pharmaceutical manufacturing applications, providing information to allow organizations to benchmark their practices, and improve upon them.

This Guide considers gases that come into direct contact with the biopharmaceutical and pharmaceutical manufacturing process streams, including:

• nitrogen
• oxygen
• argon
• carbon dioxide
• compressed air

These process streams include bodily contact surfaces of invasive medical devices and fluid paths of medical devices that are used for intravenous solution, blood, or other critical applications to administer life saving or sustaining fluids.

The Guide focuses on defining cost effective engineering approaches and practices used to deliver a process gas systems for a manufacturing facility in a timely manner providing clarification of issues critical to product quality for the production of biopharmaceutical and pharmaceutical drug substances and drug products.

Specifically, the Guide addresses the process of designing, constructing, commissioning, and qualifying a process gas system regulated by the FDA or other regulatory authority, such as the EMA.

This Guide provides the pharmaceutical manufacturing and engineering community with a common language and understanding of gas systems, promoting a Science and Risk-Based basis for the planning, construction, commissioning, and qualification of gas systems used to support production.

Five key concepts are applied throughout the Guide:

• Product and Process Understanding
• Life Cycle Approach within a Quality Management System
• Scalable Lifecycle Activities
• Science-Based Quality Risk Management
• Utilizing Supplier Involvement

The Guide is intended to align with:

• ICH Q9 Quality Risk Management
• ASTM E2500-07 Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment