Articles by Frances DeGrazio - Pharmaceutical Technology

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Articles by Frances DeGrazio

Considering Extractables And Leachables For Prefilled Syringes

Feb 1, 2011

Multiple materials are involved in the packaging of drug products in prefillable syringes.

The Importance of Leachables and Extractables Testing for a Successful Product Launch

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.
Jan 2, 2008

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.

Injectable Administration Systems

During the past 30 years, manufacturers have developed sophisticated packaging and delivery systems to support the requirements of traditional and complex biologics. Highest among the requirements during this time has been the increased focus on quality and cleanliness. This article discusses the evolution of packaging and delivery systems for injectable administration systems as the pharmaceutical and biotechnology industry evolved during the past 30 years. It also explores the future of packaging and..
Jul 2, 2007

During the past 30 years, manufacturers developed sophisticated packaging and delivery systems to support the requirements of traditional and complex biologics, including quality and cleanliness. This article discusses the evolution of packaging and delivery systems for injectable administration systems as the pharmaceutical and biotechnology industry evolved during the past 30 years. It also explores the future of packaging and delivery systems as technology and drug development advance.

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