RT Journal Article
SR Electronic
T1 Extractables from Integrated Single-Use Systems in BioPharmaceutical Manufacturing. Part I. Study on Components (Pall Kleenpak™ Connector and Kleenpak Filter Capsule)
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 322
OP 338
VO 63
IS 4
A1 Weibing Ding
A1 Rebecca Nash
YR 2009
UL http://journal.pda.org/content/63/4/322.abstract
AB Single-use systems for manufacturing biopharmaceuticals can include filter capsules, connectors, tubing, and polymeric film biocontainers. In order to tackle the variety of extractable compounds from these fairly complex systems, we first studied such systems' representative components, and then examined an entire single-use system comprised of filtesr, connectors, tubing, and biocontainers. This approach greatly simplifies the identification of the extractable compounds from the whole system. The test design was based on common, actual processes conducted under worst-case conditions. Part 1 of this series of papers describes a systematic study of extractables from two components, a sterile connector and a capsule filter, in water and ethanol as model solvent extractants. The complete extractables results were obtained using a combination of qualified analytical methods. The results indicated that the potential for the connector and the capsule filter to release leachable materials in significant amounts into the chemically compatible drug product is very low, taking into account the less vigorous conditions in most processes and dilution effects when compared to the water and ethanol extraction conditions reported here. Application of study results is discussed.