PT  - JOURNAL ARTICLE
AU  - Dennis R. Jenke
AU  - David Zietlow
AU  - Mary Jo Garber
AU  - Salma Sadain
AU  - Duane Reiber
AU  - William Terbush
TI  - Accumulation of Organic Compounds Leached From Plastic Materials Used in Biopharmaceutical Process Containers
DP  - 2007 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 286--302
VI  - 61
IP  - 4
4099  - http://journal.pda.org/content/61/4/286.short
4100  - http://journal.pda.org/content/61/4/286.full
SO  - PDA J Pharm Sci Technol2007 Jul 01; 61
AB  - 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 utilization of plastic containers to prepare, transport, and store an assortment of solutions including buffers, media, and in-process and finished product. The direct contact of such containers with the product at one or more points in its lifetime raises the possibility that container leachables may accumulate in the finished product. The interaction between several commercially available container materials and numerous model test solutions (representative of buffers and media used in biopharmaceutical applications) was investigated. This paper summarizes the identification of leachables associated with the container materials and documents the levels to which targeted leachables accumulate in the test solutions under defined storage conditions.