1Bio-Process System Alliance Extractables and Leachables Subcommittee. Recommendations for extractables and leachables testing [J. Bioprocess Int, 2007, 5 (1 l) : 36-49.
2Levy RV, Jornitz MW. Types of filtration [J]. Adv Biochem Eng Biotechnol, 2006, 98: 1-26.
3Wakankar AA, Wang Y J, Canova-Davis E, et al. On Developing a process for conducting extractable- leachable assessment of components used for storage of biopharmaceuticals [J]. JPharm Sci, 2010, 99 (5) : 2209-2218.
4Ding W, Martin J. Implementing single-use technology in biopharmaceutical manufacturing. An approach to extratables/ leachables studies. Part one. Connectors and filter E J]. Bioprocess Int, 2008, 6 (9): 34-41.
5Ding W, Martin J. Implementing single-use technology in biopharmaceutical manufacturing. An approach to extratables/ leachables studies. Part two. Tubing and biocontainers [J. Bioprocess Int, 2009, 7 (5) : 46-55.
6Safety thresholds and best practices for extractables and leachables in orally inhaled and nasal drug products, product quality research institute (PQRI), 2006:105-155.
7ELSIE. Extractables and leachables safety information exchange EEB/OL]. http://www.elsiedata.org/elsie-database. htm.
