RT Journal Article
SR Electronic
T1 Accumulation of Organic Compounds Leached From Plastic Materials Used in Biopharmaceutical Process Containers
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 286
OP 302
VO 61
IS 4
A1 Jenke, Dennis R.
A1 Zietlow, David
A1 Garber, Mary Jo
A1 Sadain, Salma
A1 Reiber, Duane
A1 Terbush, William
YR 2007
UL http://journal.pda.org/content/61/4/286.abstract
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.