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The new ISPE Guide on Process Gases
GxP
Regulatory and SpecificationsProcess and EquipmentMonitoringCommissioning and QualificationConclusion
Keywords: Compressed Air | Clean Gases | GMP | ISPE | Sustainability
Abstract
About two years have now passed since the last series of articles on the subject of sustainability [1]. Are all heating, ventilation and air conditioning (HVAC) and water systems now highly efficient? This article provides new material to continue the journey towards CO2 neutrality in pharmaceutical facilities. In Oct 2023, a new ISPE Good Practice Guide on Process Gases was published [2]. The guide deals with compressed air generation in pharmaceutical facilities and pharmaceutical gases. This article explains what has changed since the last edition and why it is worth reading the new ISPE guide.
Dipl. Ing. (FH) Fritz Röder · Merck Healthcare and M. Sc. Stephan Neumann · Boehringer Ingelheim Corporate Center
Correspondence:
Dipl. Ing. (FH) Fritz Röder
Merck Healthcare KGaA, Frankfurter Str. 250, 64293 Darmstadt
roederfritz@gmail.com
 | Dipl. Ing. (FH) Fritz Röder is Director – Site Account Engineer at Merck Healthcare KGaA in Darmstadt. He has 16 years of industry experience in various companies and roles within engineering, quality and project management. Fritz is a member of the European Directorate for the Quality of Medicines & HealthCare (EDQM) water group and the International Society for Pharmaceutical Engineering (ISPE). |
 | M. Sc. |
