Combining a Respiration-Based Method with Universal qPCR for 3-Day Rapid Sterility Testing [0.03%]
结合呼吸法和通用qPCR的3天快速无菌检测方法
Noah E Wallace,Afshan S Kidwai,Michael Knight et al.
Noah E Wallace et al.
In this article, we present a rapid sterility method with a time to detection of 3 days and a limit of detection (LOD) of 1 CFU for testing both cell-therapy drug products and E. coli DNA plasmid preparations. The new method combines the au...
Pseudomonas aeruginosa contamination in purified water systems: case study in a pharmaceutical industry [0.03%]
制药行业中纯化水系统的铜绿假单胞菌污染：案例研究
Larissa Moreira Ribeiro,Rafael Marques Pereira Poeys de Carvalho,Gustavo Luis de Paiva Anciens Ramos
Larissa Moreira Ribeiro
Purified water is critical to the pharmaceutical industry. It is used at various stages of production and is subject to strict quality standards. This paper presents a case study of Pseudomonas aeruginosa microbiological contamination in a ...
Recommendations to Streamline and Optimize USP Sterilization Informational Chapters: PDA Comments to USP and [0.03%]
关于优化USP灭菌信息章节的建议:PDA致USP的意见书
Michael Sadowski,Kenneth Paddock,Arnan Ben-David et al.
Michael Sadowski et al.
This paper reviews USP's proposed consolidation of sterilization informational chapters, particularly revised USP and , concluding that it creates significant technical gaps and perpetuates redundancies and areas of misalignment with estab...
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...