From Traditional Statistics to Adaptive Multivariate Models: Exploring the Role of AI in Modern Pharmaceutical Manufacturing [0.03%]
从传统统计到自适应多元模型：探讨人工智能在现代制药制造中的作用
Mario Stassen,Matt Schmucki,Francisco Valero et al.
Mario Stassen et al.
Modern pharmaceutical manufacturing increasingly relies on high-frequency, high-dimensional and dynamically evolving data. Traditional statistical tools-such as univariate Statistical Process Control (SPC), Shewhart logic and Nelson's rules...
Issues to Consider in Liquid Extraction Testing of Surfaces for Particulate Matter [0.03%]
表面液相提取法测试颗粒物需考虑的关键问题
Klaus Wormuth,Fanny Gaston,Veronique Cantin et al.
Klaus Wormuth et al.
Formulation ingredients, process fluids, drug substance, and drug product contact many types of material surfaces during the manufacturing of pharmaceuticals. To achieve the requirements for subvisible and visible particulate matter in fina...
Justification and Impact of Reduced Sampling Flow Rates for Total Particle Counting in Grade A Environments [0.03%]
净化A级区内颗粒物总数检测时减少取样流量的理由及影响因素分析
Petra Merker,Didier Hélal,Svetlana Kiseleva et al.
Petra Merker et al.
The increasing evaluation and adoption of Biofluorescent Particle Counters (BFPCs) for Grade A environments have introduced instruments that operate at lower flow rates, such as 5 L/min, to simultaneously count both viable and total particl...
Inner diameter of hypodermic needles: A critical factor in prefilled syringe design [0.03%]
预填充注射器设计中针头内径这一关键因素
Remo Eugster,Cormac McCrea,Simon Knappke et al.
Remo Eugster et al.
In the frame of pharmaceutical device development, the evaluation of component properties and their effects on overall device performance characteristics poses a substantial challenge. The hydrodynamic inner diameter (IDh) of a staked-in ne...
A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas [0.03%]
基于PAT的粒子计数系统安装及运行框架用于ISO-8(非无菌)控制区预限值粒径分布变化检测
Gowtham Nakka,Sakshi Gupta,Kartik Reddy Katti
Gowtham Nakka
ISO 14644-1 defines ISO-8 cleanrooms, often found in pharmaceutical manufacturing facilities, by maximum allowable concentrations of airborne particles at specified threshold sizes (commonly ≥0.5 μm and ≥5.0 μm) within a classification ...
Using Positive Controls to Define the Defect Detection Range for CCIT Method Development and Validation [0.03%]
利用阳性对照定义CCIT方法开发和验证中的缺陷检测范围
Ken Victor,Allison Alix Caudill,Peter Grant et al.
Ken Victor et al.
In recent years, the pharmaceutical industry has moved towards using quality by design (QbD) principles to ensure safety and efficacy in parenteral products. Developing and validating container closure integrity test (CCIT) methods that can...
Patient-Centric Drug Delivery: Establishing Injection Hold Time Limits for Large Volume Autoinjectors [0.03%]
以患者为中心的药物递送：建立大体积自动注射器的持针时间限制
Dana Cabrita,Daniel Miranda,Ankur Kulshrestha
Dana Cabrita
Administering large volumes of medication via subcutaneous or intramuscular injection often requires tradeoffs to balance patient comfort with effective therapeutic outcomes. The shift toward patient-centric drug delivery has driven the dev...
Gas flow through micro-capillaries â which flow law is most suitable to predict the flow rate through micro-capillaries? [0.03%]
微管气体流动研究——哪种流体动力学规律可以最好地预测微管的气体流量？
Christian Proff,Charles E Pierce,Irwann Le Bouquin
Christian Proff
In pharmaceutical quality control, capillaries are the primary positive controls able to cover a wide range of gas flow rates during Container Closure Integrity (CCI) testing. They serve as the physical benchmarks for analytical methods to ...
Laura Brennan,Dr Terra Kremer,Gary Feehan et al.
Laura Brennan et al.
Aim: Pharmaceutical manufacturing companies have rotated different cleanroom disinfectants for many years. However, the reasons for this rotation have not always been clear and if the question is posed to several differen...