Insights for the use of Enzyme Indicators in Hydrogen Peroxide Bio-Decontamination Cycle Validation [0.03%]
酶指示剂用于氢 peroxide生物除菌周期验证的思考
Kingslea Gabbott,Emilie Bertin,Callum Dew et al.
Kingslea Gabbott et al.
Enzyme Indicators (EIs) are strips of purified thermostable adenylate kinase (tAK) which are currently used across the world in the pharmaceutical industry to quantitatively assess bio-decontamination efficacy of hydrogen peroxide (H2O2).Ad...
Impact of Storage Orientation and Duration on Prefilled Syringe Performance: Break-Loose and Glide Forces, and Injection Time Across Multiple Time Points [0.03%]
储存方式及时间对预装注射器性能的影响：不同时间点下的初始突破力、滑动阻力和注射时间
Vincent Mensah,Samira Munkaila,Hao Wang et al.
Vincent Mensah et al.
This study investigates the dynamics of break loose glide force (BLGF) in prefilled syringes (PFS) and injection time in autoinjectors (AI) across different orientations and time points, focusing on their impact on drug delivery performance...
Richard Denk,Reinhold Maeck,Dirk Motzkus et al.
Richard Denk et al.
This article provides comprehensive guidance on the safe handling, inactivation and disposal of biohazardous waste generated in biomanufacturing processes. Effective waste treatment is a crucial element of biosafety management, as improper ...
Single-Use Systems between Compliance and Circularity: A Critical View under EU-GMP-Annex 1 and European Green Deal [0.03%]
一次性系统在符合性和循环性之间的关系：在欧盟GMP附录1和欧洲绿色协议下的批判性观点
Nicolas Huber
Nicolas Huber
The revision of EU-GMP-Annex 1 has accelerated the adoption of single-use systems (SUS) in aseptic pharmaceutical manufacturing by favoring closed, prequalified equipment that support contamination control while reducing cleaning effort, cr...
Investigation of Fill-Finish Tubing Compatibility in the Absence of Protein Stabilizers [0.03%]
无蛋白稳定剂时西林瓶与胶塞相容性研究
Stephanie K Vargas,Saeed Moshashaee,TerunaJ Siahaan
Stephanie K Vargas
Optimization of the fill-finish process for a biotherapeutic is imperative for the highest quality drug product. Fill-finish is the last step in manufacturing and the last opportunity for intervention prior to entry into the supply chain. T...
Data-Driven Contamination Control: Leveraging Inferential Statistics to Confirm State of Control Through Objective Performance Indicators [0.03%]
基于数据的污染控制：通过客观绩效指标利用推理统计确认污染控制状态
Walid El Azab
Walid El Azab
Current Contamination Control Strategy (CCS) performance reviews in pharmaceutical manufacturing often rely on descriptive statistical trending of Key Performance Indicators (KPIs), focusing narrowly on compliance within defined periods rat...
Root Cause Determination for Customer Complaint Biopharmaceutical Drug Product Samples with Abnormal Appearance [0.03%]
生物药产品外观异常客户投诉主因确定
Yiwei Ma,Jian Liu,Alejandra Gallegos et al.
Yiwei Ma et al.
Customer complaints due to drug product abnormalities may arise even with strict quality control measures at the manufacturing and healthcare provider levels, posing serious challenges for the manufacturers. In this paper, we report three c...
James Agalloco
James Agalloco
This manuscript reviews the history of terminal sterilization regulation and process expectations. Practices for this culminated in the EMA / PIC/S Decision Trees (EMA/CHMP/CVMP/QWP/850374/2015, March 2019) which outlines recommended proces...
Gamma Irradiation of Ready-to-Use Injectable Aqueous Suspensions: Impact on Particle Size, Rheology, Interfacial Properties, and Polymer Stability [0.03%]
γ射线辐照即用型注射用水性悬浮液的影响：对粒径、流变学、界面性质和聚合物稳定性的影响
Swetha Ainampudi,Matthew Zajac,Sushesh Srivasta Palakurthi et al.
Swetha Ainampudi et al.
Ready-to-use (RTU) long-acting injectable aqueous suspensions offer sustained drug release but present significant challenges for terminal sterilization. While aseptic processing is frequently used for suspension manufacturing, it lacks the...
Development, Validation, and Implementation of a Pharmaceutical Facility Disinfection Program [0.03%]
制药设施消毒计划的制定、验证与实施
James Polarine,Matt Hofacre,Tony Cundell
James Polarine
Maintaining microbial control in pharmaceutical manufacturing environments is a cornerstone of Good Manufacturing Practices (GMP). This comprehensive review outlines the development, validation, and implementation of robust cleaning and dis...