Contract Pharma Staff11.10.20
Dalton Pharma Services, a North-American contract drug manufacturing organization has added instrumentation to perform extractables and leachables determining on container closure systems.
Extractables are organic and inorganic contaminants such as plasticizers, elastomers, oligomers, dyes, elemental impurities etc. that can be extracted from the surfaces of packaging components under extreme conditions such as elevated temperature and pressure or with exposure to organic solvents. Leachables are defined as organic and inorganic contaminants that can be released from the surface of container closure systems under standard storage conditions.
Extractables and leachables (E&Ls) may be inherently toxic and can contaminate the drug product. The enhanced regulatory standards necessitates pharma industry to develop sensitive and accurate analytical methods to detect, identify, and quantitate extractables and leacheables in drug product, as per U.S. FDA 21 CFR 211.94(a) and European Commission Directive (2001/83/EC).
“We are excited to add extractables and leachables contract analytical testing services to our Drug Development capabilities,” said Peter Pekos, chief executive officer, Dalton Pharma Services. “Dalton can now ensure that container closure systems in aseptic fill/finish are suitable in the development of our innovative clients’ new medicines. Adding this service to Dalton’s drug development and manufacturing capabilities ensures that our client’s products are free from impurities and sources of contamination in our clients products from containers and packaging materials.”
Extractables are organic and inorganic contaminants such as plasticizers, elastomers, oligomers, dyes, elemental impurities etc. that can be extracted from the surfaces of packaging components under extreme conditions such as elevated temperature and pressure or with exposure to organic solvents. Leachables are defined as organic and inorganic contaminants that can be released from the surface of container closure systems under standard storage conditions.
Extractables and leachables (E&Ls) may be inherently toxic and can contaminate the drug product. The enhanced regulatory standards necessitates pharma industry to develop sensitive and accurate analytical methods to detect, identify, and quantitate extractables and leacheables in drug product, as per U.S. FDA 21 CFR 211.94(a) and European Commission Directive (2001/83/EC).
“We are excited to add extractables and leachables contract analytical testing services to our Drug Development capabilities,” said Peter Pekos, chief executive officer, Dalton Pharma Services. “Dalton can now ensure that container closure systems in aseptic fill/finish are suitable in the development of our innovative clients’ new medicines. Adding this service to Dalton’s drug development and manufacturing capabilities ensures that our client’s products are free from impurities and sources of contamination in our clients products from containers and packaging materials.”
