The International Society for Pharmaceutical Engineering (ISPE) published the document "ISPE Good Practice Guide - Process Gases" in August 2011.
This detailed document (141 pages) deals with the current best practices for the handling of gases which come into direct contact with the biopharmaceutical and pharmaceutical production processes or products. These include nitrogen, oxygen, argon, carbon dioxide and compressed air.
The main focus of this Guide is on the development, the establishment, the implementation and the qualification of process gas systems regulated by international regulatory authorities, including the FDA and the EMA.
One paragraph is dedicated to "User Requirements" and the necessary documentation and the equipment-performance requirements as well as to the regular maintenance of process gas systems. Further subchapters deal with compressors, air treatment, dryers, filters, valves, monitoring, risk assessment, etc.
The Guide should align with the principles of ICH Q9 and ASTM-E2500. The objective of this Guide is to create a common language and understanding of gas systems for the pharmaceutical industry as well as for the Engineering partners.
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)