Cover -- Title Page -- Copyright -- Contents -- Preface -- General Remarks -- Chapter 1 Medicinal Gases - Manufacturing -- 1.1 Where Do the Gases Come from? -- 1.1.1 Gases Obtained from Air: Oxygen, Nitrogen, Argon, Xenon -- 1.1.1.1 Oxygen -- 1.1.1.2 Nitrogen -- 1.1.1.3 Argon -- 1.1.1.4 Xenon -- 1.1.2 Gases Separated from Other Sources: Helium, Carbon Monoxide, Methane -- 1.1.2.1 Helium -- 1.1.2.2 Carbon Monoxide -- 1.1.2.3 Methane -- 1.1.3 Gases from Chemical Synthesis: Carbon Dioxide, Nitric Oxide, Nitrous Oxide -- 1.1.3.1 Carbon Dioxide -- 1.1.3.2 Nitric Oxide -- 1.1.3.3 Nitrous Oxide -- 1.1.4 Gas Mixtures for Inhalation -- 1.1.4.1 Reconstituted (Synthetic) Air -- 1.1.4.2 Compressed Medical Air -- 1.1.4.3 Nitrous Oxide 50 vol% in Oxygen -- 1.1.4.4 Nitric Oxide Approximately 1000 ppm in Nitrogen -- 1.1.4.5 Mixtures with the General Composition Carbon Monoxide, Helium in Synthetic Air (Carbon Monoxide Ranging between 0.2 and 0.3 vol%, Helium between 8 and 18 vol%) -- 1.1.4.6 Carbogen (5 vol% Carbon Dioxide in Oxygen) -- 1.1.5 Gas Mixtures for Reference - Calibration Gas Mixtures -- Chapter 2 Pressure Vessels and Their Accessories -- 2.1 Transportable Pressure Receptacles: Pressure Cylinders -- 2.1.1 Seamless Steel Cylinders -- 2.1.2 Seamless Aluminum Cylinders -- 2.1.2.1 Specifics of Aluminum Cylinders -- 2.1.3 Welded Steel Vessels -- 2.1.4 Lightweight Wrapped Steel or Aluminum Cylinders -- 2.1.5 Pharmaceutical View on Cylinders as Containment for Drugs -- 2.1.5.1 European Pharmacopoeia View on Cylinders as Containment for Drugs -- 2.1.5.2 Inner and Outer Surfaces of Cylinders -- 2.1.6 Accessories for Cylinders: Valves -- 2.1.6.1 Accessories for Valves: Gaskets -- 2.1.6.2 Valves with Integrated Residual Pressure/Nonreturn Cartridge (NRV/PRV) -- 2.1.6.3 Integrated Valves.

2.2 Non-transportable Pressure Receptacles: Stationary (Pressure) Tanks for Cryogenic Liquids -- 2.2.1 Safety Measures on Stationary Tanks -- 2.2.2 European Pharmacopoeia View on Cryo-Tanks as Containment for Drugs -- 2.2.3 Inner and Outer Surfaces of Cryo-Tanks -- 2.2.4 Accessories for Cryo-Containers -- 2.2.5 Choice of the Good Location for Tanks -- 2.3 Medicinal Gas Pipeline Systems (MGPS) -- 2.3.1 Elements of a Medical Gas Pipeline System (MGPS) -- 2.3.1.1 Gas Terminal Units (Wall Sockets) -- 2.3.2 Tests and Checks before Going Onstream -- 2.3.3 Operation of a Central Medical Supply System -- 2.3.4 Maintenance and Service, Pharmaceutical View -- Chapter 3 Analytical Methods for Gases (as Described in Ph. Eur.) -- 3.1 Sampling -- 3.1.1 Permanent Gases -- 3.1.2 Gases Liquefied under Pressure -- 3.1.3 Cryogenic Gases -- 3.2 Gas Analytical Methods -- 3.2.1 Infrared (IR-) Spectrometry -- 3.2.1.1 Calibration -- 3.2.2 Gas Chromatography (Lit) -- 3.2.2.1 Calibration -- 3.2.3 Chemiluminescence -- 3.2.3.1 Calibration -- 3.2.4 Paramagnetic Measurement -- 3.2.4.1 Calibration -- 3.2.5 Moisture Measurement -- 3.2.5.1 Calibration -- 3.2.6 Fluorescence Analysis -- 3.2.6.1 Calibration -- 3.2.7 Test Tubes -- Chapter 4 Monographs for Gases in the European and National Pharmacopoeias -- 4.1 European Pharmacopoeia Specifications -- 4.1.1 General Composition of Monographs -- 4.1.2 Use of Monographs in the Industry -- 4.1.3 Other Descriptions from the Ph. Eur. -- Chapter 5 Production of Medical Gases - Special Handling to Comply with GMP Rulings -- 5.1 History - Gases Becoming Medicinal Products -- 5.2 Classification of Gases or Gas Mixtures as Medicinal Products -- 5.2.1 Conclusion -- 5.3 Basic Requirements (Volume 4, Part I) ([79] - GMP-Guidelines) -- 5.3.1 Pharmaceutical Quality System (PQS) and ICH Q10 -- 5.3.2 Personnel.

5.3.3 Premises and Equipment -- 5.3.3.1 Annex 6 -- 5.3.4 Documentation -- 5.3.5 Production -- 5.3.5.1 Annex 6 -- 5.3.6 Quality Control -- 5.3.6.1 Annex 6 -- 5.3.7 Outsourced Activities -- 5.3.8 Complaints and Product Recall -- 5.3.9 Self-Inspection -- 5.4 Basic Requirements for Active Substances Used as Starting Materials (Part II of the GMP-Guide) -- 5.4.1 Annex 6 -- 5.5 GMP-Related Documents (Part III of the GMP Guide) -- 5.5.1 Site Master File (SMF) -- 5.5.2 ICH-Q9 Quality Risk Management -- 5.5.3 Q10 Note for Guidance: PQS -- 5.5.4 MRA Batch Certificate -- 5.5.5 Written Confirmation -- Chapter 6 Requirements of the New Good Distribution Practice (GDP) -- 6.1 Gas in Packages - No Difference from Other Medicinal Products -- 6.1.1 GDP - Targets and Tools -- 6.1.1.1 GDP - Quality Management -- 6.1.1.2 GDP - Personnel -- 6.1.1.3 GDP - Premises and Equipment -- 6.1.1.4 GDP - Documentation -- 6.1.1.5 GDP - Operations -- 6.1.1.6 GDP - Complaints, Returns, Suspected Falsified Medicinal Products, and Medicinal Product Recalls -- 6.1.1.7 GDP - Outsourced Activities -- 6.1.1.8 GDP - Self-Inspections -- 6.1.1.9 GDP - Transportation -- 6.1.1.10 GDP - Specific Provisions for Brokers -- 6.1.1.11 GDP - Conclusions -- Chapter 7 Safe Handling of Gases -- 7.1 Safe Handling of Gases -- 7.1.1 Hazards and Risks -- 7.1.2 Safety and the Pressure Container -- 7.1.3 Main Technical Risks -- 7.1.3.1 Storage -- 7.1.3.2 Transport -- 7.1.3.3 Application -- 7.1.4 Pharmaceutical Safety -- 7.2 Safety and Pressure -- 7.3 The Compound's Chemical Properties -- 7.4 Cryogenic Liquids: Low Temperature and Vast Development of Gas -- 7.5 Gases Tapped from Piping Systems: Cross-Contamination and Contamination by Insufficient Handling, Memory Effects -- References -- Abbreviations -- Index -- EULA.