DuPont™ Dymel® 227ea/P is a non-ozone-depleting alternative propellant for pharmaceutical applications. It is available for commercial use, is manufactured in full compliance with the U.S. Food and Drug Administration's (U.S. FDA) "current Good Manufacturing Practices" (cGMP) and meets the requirements of health authorities worldwide.
Dymel® 227ea/P is supplied from our El Dorato plant in Arkansas, which has been through very thorough and detailed cGMP inspections by the U.S. FDA. On all occasions, the plant was found to be in compliance, and was not cited for any deficiencies. As a result, it has been designated by the U.S. FDA as an approved site for the supply of pharmaceutical grade propellants.
DuPont owns and operates its own facilities and manages its own compliance. Dymel® 227ea/P is manufactured in a separate facility that is cGMP compliant and dedicated solely to its production. This propellant and its blends are shipped throughout the world in dedicated containers ranging in size from 68 kg to 20 metric tons.
The chemical composition of Dymel® 227ea/P is 1,1,1,2,3,3,3-heptafluoropropane (HFA-227) and the pharmaceutical grade has stringent purity and handling requirements. Dymel® 227ea/P is a medium pressure, non-flammable, non-ozone-depleting fluorocarbon propellant.
The International Pharmaceutical Aerosol Consortium for Toxicology Testing of HFA-227 (IPACT-II) is an industry organization of pharmaceutical companies that has evaluated the safety of HFA-227ea for use in MDIs. IPACT-II's toxicological and clinical evaluations establish HFA-227ea's safety in support of its members' marketing applications for pharmaceutical products such as MDIs. Drug Master Files have been submitted worldwide. As a result, Dymel® 227ea/P received affirmation from worldwide governmental bodies for use in metered-dose inhalers and other pharmaceutical applications. Drug Master files have been submitted for Dymel® 227ea/P in the U.S. and Canada and an Excipient Master File for this material has been deposited in the European Union.
Contact us to request an Access Letter to the DuPont™ Dymel® 227ea/P Drug Master File in conjunction with your company's product approval.