Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Hal Baseman"'
Publikováno v:
Biomedical Instrumentation & Technology. 57:8-17
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5524a2c743a23e1daba8b7a14515775e
https://doi.org/10.2345/0899-8205-57.1.8
https://doi.org/10.2345/0899-8205-57.1.8
Publikováno v:
Biomed Instrum Technol
In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufa
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4f2078ce383ed98cec6688c19925aaf
https://doi.org/10.5731/pdajpst.2021.012706
https://doi.org/10.5731/pdajpst.2021.012706
Publikováno v:
PDA journal of pharmaceutical science and technology. 76(6)
Interventions performed by personnel during an aseptic process can be a key source of microbiological contamination of sterile biopharmaceutical products, irrespective of the type of manufacturing system used. Understanding the relative risk of this
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2f9abddd0cb0c11636dd2d6ad1cfd7a4
https://pubmed.ncbi.nlm.nih.gov/35613741
https://pubmed.ncbi.nlm.nih.gov/35613741
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, thi
Autor:
Hal Baseman, Trabue D. Bryans, Harry Frederick Bushar, Joyce M. Hansen, Eamonn Victor Hoxey, Stan Lam, Byron J. Lambert, Vu H. Le, Andrew L. Lewis, Brad Lundahl, James Niederecker, Michael H. Scholla, Jane Severin, Marc L. Speck, Donna Swenson, Steven Turtil, Jennifer Van Mullekom, Thierry Wagner, Scott Weiss
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::32381f9087817f7c4d01e08735518ccc
https://doi.org/10.1016/b978-0-12-805082-8.09994-1
https://doi.org/10.1016/b978-0-12-805082-8.09994-1
Autor:
Sue Schniepp, Post-Sterilization Integrity Test Task Force, Karen Bartel, Hemisha Ly, Gabriele Gori, Hal Baseman, Pda Pre Use, Michiel Rook, Russell E. Madsen, Maik Jornitz, Richard Levy
Publikováno v:
PDA journal of pharmaceutical science and technology. 66(5)
EU Annex I, paragraph 113 states: “The integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such as bubble point, diffusive flow or pressure hold.” The paragraph w
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94811e9542cd244ae0c19a33337ca13b
https://pubmed.ncbi.nlm.nih.gov/23035023
https://pubmed.ncbi.nlm.nih.gov/23035023
Autor:
Hal Baseman
Publikováno v:
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition ISBN: 9781439850930
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3cf7084ccd6ebe501d45bffe1897dc9e
https://doi.org/10.1201/b12013-3
https://doi.org/10.1201/b12013-3
Autor:
James, Agalloco, James, Akers, Hal, Baseman, Richard, Boeh, Russell, Madsen, Steven, Ostrove, Anthony, Pavell
Publikováno v:
PDA journal of pharmaceutical science and technology. 63(1)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::2620802f53332406cd81f41a5e559559
https://pubmed.ncbi.nlm.nih.gov/19455938
https://pubmed.ncbi.nlm.nih.gov/19455938