ISPE Publishes Guide for Process Gases - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

ISPE Publishes Guide for Process Gases


ePT--the Electronic Newsletter of Pharmaceutical Technology

Last week, the International Society for Pharmaceutical Engineering (ISPE) published a guidance document titled ISPE Good Practice Guide: Process Gases. The guide defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams (e.g., nitrogen, oxygen, argon, carbon dioxide, and compressed air).

ISPE Good Practice Guide: Process Gases describes cost-effective engineering approaches for establishing a process-gas system for a manufacturing facility in a timely manner. The guide is meant to help users avoid increasing facility installation and operation costs. It also examines issues crucial to product quality for the production of biopharmaceutical and pharmaceutical drug substances and drug products.

The bulk of the guide is dedicated to the process of designing, constructing, commissioning, and qualifying a process-gas system that is regulated by international regulatory authorities, including FDA and EMA. One section provides advice about developing user-requirements documentation, including how to define user requirements, equipment-performance requirements, and maintenance requirements, for a process-gas system. Other sections describe design options for process-gas generation systems, compressed-air systems, distribution systems, and control and monitoring systems. Finally, the guide explains how to assess the risk in process-gas systems, how to establish the systems’ final design, and how to shape maintenance and operation protocols for the systems.

The guide is intended to provide a common language and understanding of gas systems to the pharmaceutical-manufacturing and engineering communities. It addresses the key concepts of product and process understanding, a life-cycle approach within a quality-management system, scalable life-cycle activities, science-based quality risk management, and using supplier involvement. The guide promotes a science- and risk-based approach to process-gas systems, and is intended to follow the principles of ICH Q9 and ASTM-E2500.

ISPE is an international, not-for-profit association of pharmaceutical science and manufacturing professionals who collaborate with global regulatory agencies and industry leaders. The organization develops guides and solutions for good manufacturing practices that are intended to improve the industry’s operations.

ISPE Good Practice Guide: Process Gases
www.ISPE.org/ispegpg/ProcessGases

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here