ISPE Briefs: New Good Practice Guide Covers Pharmaceutical Gas Systems
The new ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction materials and updates on current good practices. It was revised based on the latest International Organization for Standardization in Pharmaceuticals, American Society for Testing and Materials, and American Society of Mechanical Engineers standards and is aligned with the latest regulatory guidance.
“This guide provides comprehensive information about process gases,” said Guide Co-Lead Stephan Neumann, Global Governance, Critical Utilities, Boehringer Ingelheim GmbH. “It covers all aspects of pharmaceutical gas systems, including generation technologies and design options for control/monitoring and system operation, and sustainability requirements. It also presents general properties and characteristics of the atmospheric gases and compressed air, along with pharmacopeia requirements.”
This second edition adopts the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) integrated commissioning and qualification strategy to streamline the effort for process gas systems. System designers are encouraged to consider where the gas will be used and for what purpose when developing the user requirements for use points.
“This is the best guidance in the industry for process gases,” said guide Co-Lead Nissan Cohen, Owner, Bio-pharmaceutical Water Doc. “There are annexes of the guide illustrating examples for sampling strategies for oral solid dosage, active pharmaceutical ingredients, and sterile fill and finish plants using risk assessment methodologies, process analytical technology principles, and modern manufacturing systems. This document is the only comprehensive process gas guideline in the entire biopharmaceutical industry.”
To learn more about this and other ISPE guides, visit ISPE.org/publications/guidance-documents
Meet the ISPE Staff: Nina Wang
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Nina Wang, Editor-in-Chief, Pharmaceutical Engineering®
Tell us about your role at ISPE: What do you do each day?
Before stepping into my new role as Editor-in-Chief, I served as a technical editor for guidance documents here at ISPE. While my primary responsibility was content review and refinement, my daily routine encompassed a wide range of tasks throughout the guide development process—from getting authoring teams off the ground and running and coordinating schedules all the way to the final proofread just before publication.
What do you love about your job?
The people! One of the most rewarding aspects of working at ISPE is the opportunity to collaborate with our global network of volunteers. We have the privilege of uniting individuals from around the world, each contributing their expertise and a genuine passion for sharing their knowledge. I would be remiss if I did not also mention the dedicated and hardworking team of ISPE staff.
What do you like to do when you are not at work?
On the weekends, you’ll often find me on the sidelines of a soccer field, cheering on my kids and their teams. We also enjoy discovering new places to eat or immersing ourselves in the beauty of the redwoods, as well as planning our next vacation
