A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT) [0.03%]
使用前/灭菌后完整性测试(PUPSIT)的风险评估及基于风险的方法回顾
Kelly Waldron,Amanda McFarland,Hal Baseman et al.
Kelly Waldron et al.
In January 2023, ICH Q9 was updated to include expanded guidance on risk-based decision-making, emphasizing its application in informing science-driven and strategic decisions. The revised guidance highlights that while quality risk managem...
A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT) [0.03%]
基于风险评估和风险管理的预使用/后灭菌完整性测试(PUPSIT)回顾
Kelly Waldron,Amanda McFarland,Hal Baseman et al.
Kelly Waldron et al.
In January 2023, ICHQ9 was updated to include expanded guidance on risk-based decision-making, emphasizing its application in informing science-driven and strategic decisions. The revised guidance highlights that while quality risk manageme...
Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP Visible Inspection of Injections [0.03%]
案例研究： topical ophthalmic制剂的视觉检查（包装容器为不透明和半透明容器）：向USP注射液可见异物检查标准靠拢的工作
Mary Lee Ciolkowski,Ann T Davis,Alexa Harding et al.
Mary Lee Ciolkowski et al.
Topical ophthalmic solutions, suspensions, and emulsions are typically packaged in opaque or semi-transparent plastic dropper bottles. This packaging provides resistance to breakage and controlled drop size needed in ophthalmic container sy...
Definition of particle visibility threshold in parenteral drug products - towards standardization of visual inspection operator qualification [0.03%]
注射剂产品中可见异物判定标准的确立——视觉检查员资质评定标准化之路
Filip Fedorowicz,Andreas Zerr,Roman Mathaes et al.
Filip Fedorowicz et al.
The detectability size threshold of visible particles (″visibility″ size) in the context of visual inspection of parenteral drug products has been an elusive target for several decades. The current common sense, also reflected in official...
Recommendations for Artificial Intelligence Application in Continued Process Verification [0.03%]
人工智能在持续工艺验证中的应用建议
Mario Stassen,Catarina S Leitao,Toni Manzano et al.
Mario Stassen et al.
This review paper explores the transformative impact of Artificial Intelligence (AI) on Continued Process Verification (CPV) in the biopharmaceutical industry. Originating from the CPV of the Future project, the study investigates the chall...
Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation [0.03%]
针对医疗设备可提取物和浸出物的非目标分析(NTA); 分析评价阈值(AET)和定量方法
Dennis Jenke,Piet Christiaens,Ted Heise
Dennis Jenke
Leachables leached from a medical device during its clinical use are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables as probable leachables) by screen...
Leachables Analysis from a Closed Connected Single-Use mAb Purification Process [0.03%]
封闭式单克隆抗体一次性工艺提取物分析研究报告
Alfred Haglind,Emil Håkansson,Nils Wallménius et al.
Alfred Haglind et al.
During a closed connected single-use monoclonal antibody (mAb) purification process, samples for leachables screening were gathered from two parallel processes (using different capturing chromatography), from perfusion culture to final stor...
Correlating GC/MS Relative Response Factors to Analyte's Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations [0.03%]
通过将GC/MS相对响应因子与分析物的物理化学和色谱特性相关联来促进非目标分析（NTA）中有机可提取和浸出物定量的概念和实证考虑因素
Dennis Jenke,Piet Christiaens,Philippe Verlinde et al.
Dennis Jenke et al.
Leachables in drug products and from medical devices can adversely affect patient health and thus must be identified and quantified. Accurate and protective quantitation in target analysis for leachables (and extractables as potential leach...
Evaluation of extreme depyrogenation conditions on the surface hydrolytic resistance of glass containers for pharmaceutical use [0.03%]
评估极端脱毒素条件对药用玻璃容器表面水解耐受性的影响
Massimo Guglielmi,Satoshi Arai,Peggy Georges et al.
Massimo Guglielmi et al.
This paper is the result of a round robin activity run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). The study was motivated by a concern about the risk that the depyrogenation treatment ...
A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis [0.03%]
用于存储在冷冻条件下的西林瓶容器密封性检查方法的顶空气体氧气分析法研究
Allison Alix Caudill,Ken Victor,James Veale
Allison Alix Caudill
An increasing number of pharmaceutical products require deep cold storage at cryogenic conditions, approximately -150°C to -190°C, to maintain stability and/or activity. Previous work has revealed that, at these extreme conditions, a typi...