Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole? [0.03%]
微生物污染与隔离器手套：如果这一切都归结于一个洞的大小？
Edith Filaire,Vincent Rochette,Elodie Pierre et al.
Edith Filaire et al.
Isolators play a critical role in protecting both the product and the environment, as well as the personnel involved in pharmaceutical manufacturing, analytical procedures, and sterility testing. Gloves attached to the windows and doors of ...
A Commentary on "Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit" [0.03%]
《“生物荧光颗粒计数与菌落形成单位不等价性”的述评》
Félix A Montero Julian
Félix A Montero Julian
Degradation of Obidoxime Chloride Solution for Injection upon Long-Term Storage under Field Conditions of Mediterranean Climate vs the Controlled Environment [0.03%]
奥苯溴铵氯化注射溶液在地中海气候条件下长期储存时的降解情况与控制环境下的对比研究
Constantin Itin,Meital Zur,Pavel Gorenbein
Constantin Itin
Obidoxime chloride is an antidote for nerve gas intoxication. As an emergency medicine, it is being stored by the Israel Defense Forces (IDF) scattered throughout Israel in depots without a controlled environment (field conditions), thus be...
Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water [0.03%]
开发和验证用于药物用水中痕量过氧化氢检测的Amplex UltraRed定制化检测试剂盒及测定法
Alexandra H Heussner,Marlene Hermann,Melanie Zerulla-Wernitz
Alexandra H Heussner
For clean-room technologies such as isolators and restricted access barrier systems (RABS), decontamination using hydrogen peroxide (H2O2) is increasingly attractive to fulfill regulatory requirements. Several approaches are currently used,...
Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices [0.03%]
二元醇/水溶剂体系与血液对比萃取接触血液的医疗器械中提取物的研究
Mark Anderson Jordi,Taryn Meade,Kevin Rowland et al.
Mark Anderson Jordi et al.
The analysis of extractables and leachables and subsequent risk assessment is an important aspect of the determination of biocompatibility for many medical devices. Leachable chemicals have the potential to pose a toxicological risk to pati...
Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management [0.03%]
PDA技术报告No. 89《疫苗研发及生命周期管理策略》适用性的变更实例分析及改进过程开发方法的思考
Cristiana Campa,Didier ClÉnet,Jane Halpern et al.
Cristiana Campa et al.
Vaccines are complex and a very diverse group of products with relatively long product life cycles. The manufacturing programs for these vaccines need to be continually updated to comply with evolving regulatory expectations. Members of the...
Impact of NaCl on Monoclonal Antibody Aggregation Induced by Agitation [0.03%]
NaCl对搅拌诱导的单克隆抗体聚集行为的影响
Justin K Y Hong,Wei Liu,Kai Zheng
Justin K Y Hong
Monoclonal antibodies (mAbs) are a successful class of therapeutics, but their development can be challenging due to the risk of degradation that could happen during manufacturing, storage, and clinical use. One of the common causes of degr...
Letter to the Editor [0.03%]
读者来信
Tony Cundell
Tony Cundell
Nonlinear Tissue Permeability Drives Tissue Pressure and Injection Distribution: A Computational Investigation of Subcutaneous Injections [0.03%]
非线性组织渗透性驱动组织压力和注射分布：皮下注射的计算研究
Scott Lovald,Shashank Agarwal,Anuradha Radhakrishnan et al.
Scott Lovald et al.
There is a significant opportunity to expand the understanding of subcutaneous injection mechanics with an aim to increase injectable volume while controlling tissue strain and associated subject pain. Computational modeling can evaluate th...
Finite Element Analysis of Skin Deformation and Puncture for Microneedle Array Design [0.03%]
用于微针阵列设计的皮肤变形与穿刺的有限元分析
Scott Lovald,Chris Berkey,Nikita Pak et al.
Scott Lovald et al.
The mechanics of microneedle insertion have thus far been studied in a limited manner. Previous work has focused on buckling and failure of microneedle devices, while providing little insight into skin deformation, puncture, and the final p...