A consideration of the impact of solution composition on the accumulation of organic substances leached from plastics used in container/closure systems
D Jenke, T Couch - PDA Journal of Pharmaceutical Science and …, 2006 - journal.pda.org
A multi-layered, laminated plastic material, similar to those used in flexible intravenous
solution containers, was loaded to contain known amounts of 15 model compounds whose …
solution containers, was loaded to contain known amounts of 15 model compounds whose …
Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers
DR Jenke, D Zietlow, MJ Garber, S Sadain… - PDA Journal of …, 2007 - journal.pda.org
Plastic materials are widely used in medical items, such as solution containers, transfusion
sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the …
sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the …
Accumulation of extractables in buffer solutions from a polyolefin plastic container
DR Jenke, JM Jene, M Poss, J Story… - International journal of …, 2005 - Elsevier
Plastic materials are widely used in medical items, such as solution containers, transfusion
sets, transfer tubing and devices. An emerging trend in the biotechnology industry is the …
sets, transfer tubing and devices. An emerging trend in the biotechnology industry is the …
A general assessment of the physiochemical factors that influence leachables accumulation in pharmaceutical drug products and related solutions
D Jenke - PDA journal of pharmaceutical science and technology, 2011 - journal.pda.org
The accumulation of organic compounds associated with plastic materials into
pharmaceutical products and their associated solutions has important suitability for use …
pharmaceutical products and their associated solutions has important suitability for use …
The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers
D Jenke, A Odufu, M Poss - European journal of pharmaceutical sciences, 2006 - Elsevier
Material/water equilibrium interaction constants (Eb) were determined for 12 organic model
solutes and a plastic material used in pharmaceutical product containers (non-PVC …
solutes and a plastic material used in pharmaceutical product containers (non-PVC …
Extractables/leachables from plastic tubing used in product manufacturing
DR Jenke, J Story, R Lalani - International Journal of Pharmaceutics, 2006 - Elsevier
While the ability of packaging systems to contribute leached substances to finished drug
products is well established, increasing interest is being focused on the potential …
products is well established, increasing interest is being focused on the potential …
Modeling of the leachables impact on the engineering of parenteral product container systems
DR Jenke, EK Chess, G Jakubowski - International journal of pharmaceutics, 1994 - Elsevier
This study examines the impact, from a leachables perspective, of charging a solution
contact component of a polymeric solution container. By charging such a container …
contact component of a polymeric solution container. By charging such a container …
Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations
DR Jenke - International journal of pharmaceutics, 2001 - Elsevier
The interaction between a medical device and a pharmaceutical solution it contacts may
dictate solution safety and/or efficacy. Of specific concern is the ability of device components …
dictate solution safety and/or efficacy. Of specific concern is the ability of device components …
Organic extractables from packaging materials: Chromatographic methods used for identification and quantification
D Jenke - Journal of liquid chromatography & related …, 2003 - Taylor & Francis
A review is provided, related to the chromatographic methods used to assess the
accumulation of leachable substances from packaging materials used for pharmaceutical …
accumulation of leachable substances from packaging materials used for pharmaceutical …
Validation of a liquid chromatographic method for quantitation of organic compounds leached from a plastic container into a pharmaceutical formulation
D Jenke, M Jo Garber, D Zietlow - Journal of liquid chromatography …, 2005 - Taylor & Francis
Full article: Validation of a Liquid Chromatographic Method for Quantitation of Organic
Compounds Leached from a Plastic Container into a Pharmaceutical Formulation Skip to …
Compounds Leached from a Plastic Container into a Pharmaceutical Formulation Skip to …