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pro vyhledávání: '"Roger Asselta"'
Publikováno v:
Principles and Practices of Lyophilization in Product Development and Manufacturing ISBN: 9783031126338
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c9c7baa695437ebcd68a70167c39c15c
https://doi.org/10.1007/978-3-031-12634-5_8
https://doi.org/10.1007/978-3-031-12634-5_8
Publikováno v:
Parenteral Medications ISBN: 9780429201400
This chapter discusses the important elements of extractables and leachables, with which those in the pharmaceutical industry should be familiar. Drug products, biological products, and delivery devices are regulated worldwide to protect all consumer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::93825a9f86c6390fec316cd5e9f4b02e
https://doi.org/10.1201/9780429201400-25
https://doi.org/10.1201/9780429201400-25
Autor:
Jason Franck, Roger Asselta, Yusuf Oni, Matthew Schrader, Carolina Flores-Crespo, Rao V. Mantri, Ankur Kulshrestha, Xu Song
Publikováno v:
PDA journal of pharmaceutical science and technology. 73(6)
Container closure integrity (CCI) is one of the requirements for a sterile packaging system. For vial-based systems, the capping process is a critical step in creating and ensuring an adequate seal with acceptable CCI. Container closure integrity tes