CGA’s July 2020 Safety Publications (New Releases & Revisions)
August 6, 2020
During July 2020, the Compressed Gas Association (CGA) issued the following new and revised safety standards and position statements:
CGA M-25, ICH Q3D Risk Assessment Report Elemental Impurities in Medicinal Gases
Released: July 29, 2020 (1st Edition)
Special Attribute: Harmonized publication
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a harmonized guideline for elemental impurities (EIs), Q3D in pharmaceutical products which includes medical gases, referred to as ICH Q3D.
ICH Q3D recommends a science and risk-based approach to evaluate the potential for introduction of elemental impurities (EIs) into the drug product and to determine if additional controls need to be included in the overall control strategy to ensure product quality and safety. The overall process follows the sequence identify, evaluate, and summarize.
To determine whether medicinal gases are likely to contain any EIs specified in ICH Q3D, members of the European Industrial Gases Association (EIGA) performed a risk assessment (RA) which considered which EIs could theoretically be present in the licensed drug products. The maximum daily dosages (MDD) were also calculated for each medicinal gas to determine which medicinal gases were at the highest risk.
The scope of this publication covers all packaged medicinal gases as listed in CGA M-25 produced by EIGA members and approved as designated medical gases by the U.S. Food and Drug Administration (FDA) or authorized as medicinal products in other jurisdictions. It covers both compressed and liquefied gases, supplied in high pressure cylinders as well as cryogenic liquids, supplied either by tankers into bulk storage tanks or in portable cryogenic containers. It considers all manufacturing processes, including the starting materials used, as well as the container closure systems (CCS) used to supply these medicinal gases for patient use.
CGA M-25 covers the quality of the gas up to the point of delivery into the customer’s storage tank or at the outlet valve in either high pressure cylinders or portable cryogenic containers. It does not address the quality of the gas once it has been distributed to the usage point via the customer’s pipeline system.
CGA PS-61, CGA Position Statement on Ammonia Testing in Carbon Dioxide
Released: July 24, 2020 (1st Edition)
This publication describes CGA’s position on testing for ammonia in carbon dioxide.
CGA PS-62, CGA Position Statement on Maintenance and Safety Devices on Acetylene Compressor Crankcases Without Separation Sections
Released: July 24, 2020 (1st Edition)
This publication describes CGA’s position on compressors that do not have separation sections between the crankcase and the cylinder/piston section and are equipped with a simple breather tube for pressure equilibrium in the crankcase.
CGA PS-65, Position Statement on Sumitomo Precision Products Fabricated Brazed Aluminum Heat Exchangers
Released: July 14, 2020 (1st Edition)
This publication describes CGA’s position on the mechanical integrity of Sumitomo Precision Products fabricated brazed aluminum heat exchangers.
