How to test pen injector assembly interfaces from URS to FAT and SAT: verify part tracking, reject confirmation, restarts, and data transfer evidence.
News|Articles|August 1, 2003
- Pharmaceutical Technology-08-01-2003
- Volume 2003 Supplement
- Issue 4
Aseptic Formulation and Filling Using Isolator Technology
Author(s)Jeff L. Folks
Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.
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The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill burden, weakly basic drug release, and process limits.
Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.
Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.
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