Production, Applications, and Safety
Medical gases are widely used in the healthcare industry. When working with medical gases, there are a lot of issues to be aware of, starting from the regulations concerning Good Manufacturing Practice when producing the gas to the safe storage and finally its utilization. An essential, one-stop guide for researchers and professionals whose work includes the manufacture, handling, or use of medical gases.
About the author:
Dr. Hartwig Müller was head of the Safety Department of Air Liquide Medical in Germany, a subsidiary of Air Liquide. He is a chemist from Berlin’s Technical University and spent more than 30 years in the gas industry, occupied with Specialty and Medical Gases and their analytics. During his time as pharmaceutical responsible person for Messer Griesheim (1979-2005) he was member of international working groups of the European Industrial Gas Association and an Expert to the European Pharmacopoeia Commission sub-group for Medical Gases (1984 – 2005).
GIT: What knowledge is prerequisite for the book?
Müller: The book is written to provide background knowledge for chemists and pharmacists not familiar with gases or cryogenic liquids. They should be fine with the book. Helpful would be experience in the analytical lab, not necessarily equipped for the analyses of medical gases.
GIT: What is the structure of the book?
Müller: In order to provide a clear view to previsions and needs the book describes the origin, the transport media, analytical methods, and pharmacopoeia input.
These chapters lead directly to the production methods and distribution of gases. The book ends with a detailed description of the various safety measures, indispensable to keep a high and safe working standard.
GIT: What are the typical errors encountered when it comes to handling medical gases?
Müller: Medical Gases often are underestimated because they play only a little role in the big scene of drugs and medicinal products. All gases require special handling and precautions by the user to meet numerous legal technical requirements e.g. for storage and handling, and simultaneously, when used as medicinal product, for pharmaceutical regulations. In this sense ‘Medical Gases’ gives an introductory description of the procedures and safety advice to make the user conscious of the properties and inherent hazards of gases and cryogenic liquids. Gaseous drugs are delivered in at least two different physical states, requiring different knowledge for example as cryogenic liquids or high-pressure steel cylinders. Another very common installation in hospitals related to medical gases is the medicinal central gas supply system, which is classified and operated as medical device and thus representing another set of skills related to the operation of medical devices.
GIT: Is there a big difference in national regulations regarding the analysis of gases?
Müller: Thanks to the work of the European Directorate of Quality of Medicines and Healthcare, numerous directives and rules of the European Union (summarized in the Eudralex guides) and last but not least the work of the ICH/PIC the legal requirements are at least in the European union quite similar, but with different roll-out status, depending upon the year getting membership to the union. While the European Pharmacopoeia defines specifications and provides validated analytical methods, the GMP annex 6 describes the precautions and organization during production of medical gases. As all occupied bodies are involved in communication and exchange among each other and with the industry, national authorities, and customers, a continuous flow of information about development and changes is created. This book provides descriptions of most of the important sources, so the reader can establish an information flow composed to match his individual needs.
GIT: What is your main focus in research, what is your main scientific interest?
Müller: Gases represent a fascinating class of substances, used in many different fields of medical services and industry. Important is the knowledge of how to analyze efficiently by connecting to the knowledge of the origin of the gases. Safety issues during handling of cryogenic gases remain a very important task after several accidents in this field. As the author tried to write the book without major backing of a gas company, it can be used throughout the industry.
GIT: What is the target audience for the book?
Müller: The target audience for this book includes those managers, experts or students who get in touch by chance or by profession with medical gases. The book can give a concise overview about the gases, their origin, their properties and valuable references for deeper diving into the subject. It can help closing a knowledge gap emerging both in the industry and the different country authorities.
GIT: What was the reason to write the book?
Müller: Due to the economical situation in the industry, numerous consolidations had taken place in the last twenty years. As a result, during long times since the early nineties the recruiting figures in the gas industry remained low, with the result that nowadays a complete change of management staff is taking place in most of the companies, and a huge number of experts changes to retirement in only a couple of years. By this development the knowledge basis is melting down continuously. It is part of my role as senior-expert to pass knowledge to the younger experts now growing up into their positions. Another gap is the discrepancy created by the more theoretical approach of the auditing authorities. Here this book can deliver valuable background information on why the gases are so different to other fluids. Creating a unique and solid knowledge basis is substantial to reach efficient and safe work as well as for the industry and for the authority.