Blueprint for implementing USP chapter 797 for compounding sterile preparations
ES Kastango - American journal of health-system pharmacy, 2005 - academic.oup.com
Purpose. Guidelines for adopting and successfully implementing the requirements of the
United States Pharmacopeia (USP) chapter 797 for compounding sterile preparations are …
United States Pharmacopeia (USP) chapter 797 for compounding sterile preparations are …
[HTML][HTML] Comparison of tunable diode laser absorption spectroscopy and isothermal micro-calorimetry for non-invasive detection of microbial growth in media fills
D Brueckner, D Roesti, UG Zuber, R Schmidt… - Scientific reports, 2016 - nature.com
Two methods were investigated for non-invasive microbial growth-detection in intact glass
vials as possible techniques for automated inspection of media-filled units. Tunable diode …
vials as possible techniques for automated inspection of media-filled units. Tunable diode …
Quality-control analytical methods: USP chapter< 797> compounded sterile preparations sterility requirements and their relationship to beyond-use dating
ES Kastango - International Journal of Pharmaceutical …, 2004 - search.proquest.com
High 24 hours 3 days 45 days lary (USP-NF) has been setting stan-dards since 1820; it has
been setting official enforceable standards since Table 2. Beyond-Use Dates for …
been setting official enforceable standards since Table 2. Beyond-Use Dates for …
Sterility test and procedures
L Jimenez - Microbial contamination control in the pharmaceutical …, 2004 - taylorfrancis.com
Introducing microorganisms by a contaminated pharmaceutical product parenterally or
through broken skin into the body cavities can result into disease and mortality …
through broken skin into the body cavities can result into disease and mortality …
培地充てん試験法の許容値と充てん本数および製品品質保証レベル
川村邦夫， 阿部寛 - 日本 PDA 学術誌 GMP とバリデーション, 2002 - jstage.jst.go.jp
抄録 It is no doubt that media fill (simulation) test is the best method to evaluate aseptic
processing. However, there are some problems concerning the acceptable criteria of “a …
processing. However, there are some problems concerning the acceptable criteria of “a …
[CITATION][C] Making the switch to robotic iv preparation
SJ Ciullo, I Pustovalova, J Zahra - 2019