Evaluation of the Endosafe(R) Portable Testing SystemTM for the Rapid Analysis of Biopharmaceutical Samples [0.03%]
Endosafe®便携测试系统（PTS）快速分析生物制剂样品评估研究报告摘要
Luis Jimenez,Narendra Rana,Kasey Travers et al.
Luis Jimenez et al.
The Endosafe® Portable Testing System™ (PTS™) portable system for endotoxin testing was evaluated to analyze biopharmaceutical samples such as raw materials and finished products. The installation, operational, and performance qualificat...
Extraction of stearate salts from plastic materials used in pharmaceutical applications [0.03%]
药用塑料材料中硬脂酸盐的提取
Dennis Jenke
Dennis Jenke
Plastic materials are widely used in medical items such as solution containers, infusion sets, transfer tubing, devices, processing equipment and systems, filters, and the like. Components in medical items can leach out of such items when t...
Investigation into the potential of electroporation facilitated topical delivery of cyclosporin a [0.03%]
电穿孔促进环孢素A经皮给药的潜力研究
Hong-Zhuo Liu,Yong-Jun Wang,Lu Xu et al.
Hong-Zhuo Liu et al.
Purpose: The potential for electroporation-facilitated topical transport of cyclosporin A (CysA) was investigated using rat skin. Methods: ...
Happy Birthday, ICH! [0.03%]
ICH生日快乐！
Antonio Moreira
Antonio Moreira
Visualization Techniques for Assessing Design Factors That Affect the Interaction between Pharmaceutical Vials and Stoppers [0.03%]
用于评估药用安瓿瓶与胶塞之间相互作用的设计因素的可视化技术
Philippe Lam,Al Stern
Philippe Lam
We developed several techniques for visualizing the fit between a stopper and a vial in the critical flange area, a location typically hidden from view. Using these tools, it is possible to identify surfaces involved in forming the initial ...
Evaluation of the MicroWorks, Inc. Swab Sampling System (MSSSTM) for Use in Performing Quantitative Swab Sampling [0.03%]
MicroWorks，Inc.采样布系统(MS3TM)定量擦拭取样法性能评估
Sandy Rubio,Dawn McIver,Natalie Behm et al.
Sandy Rubio et al.
The purpose of this study was to qualify the MicroWorks, Inc. Swab Sampling System (MSSS™) swab kit for use in sampling cleanroom surfaces for bioburden. A six-part study was performed to demonstrate the suitability of the swab materials, ...
The bacterial diversity of pharmaceutical clean rooms analyzed by the Fatty Acid methyl ester technique [0.03%]
脂肪酸甲酯技术在药用洁净室细菌多样性分析中的应用
Fábio Luiz C Pacheco,Terezinha De Jesus A Pinto
Fábio Luiz C Pacheco
Clean rooms are largely employed in pharmaceutical companies whose purpose is to produce sterile drugs and devices. We employed Gram staining and gas chromatography of fatty acid methyl esters extracted from whole cells of environmental iso...
Equivalence of quality control strains of microorganisms used in the compendial microbiological tests: are national culture collection strains identical? [0.03%]
用于药典微生物检测的质量控制菌株的等同性：各国菌种保藏机构保存的菌株是否相同？
Anthony M Cundell,Sonia Chatellier,Peter Schumann et al.
Anthony M Cundell et al.
The pharmacopoeias list a number of microorganisms to be used in the compendial microbiological tests for confirming the growth-promoting, indicative, and inhibitory properties of the media and demonstrating the suitability of the test for ...
A Risk-Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA Technical Report 1 Load Equivalence Topic [0.03%]
基于风险的变量灭菌装载配置验证方法学研究及应用——PDA TR No.1关于装载等同性议题的应用
Anthony Pavell,Keith A Hughes
Anthony Pavell
This article describes a method for achieving the load equivalence model, described in Parenteral Drug Association Technical Report 1, using a mass-based approach. The item and load bracketing approach allows for mixed equipment load size v...
Oleic Acid enhances all-trans retinoic Acid loading in nano-lipid emulsions [0.03%]
油酸增强全反式维甲酸在纳米脂质乳中的负载量研究
Akhayachatra Chinsriwongkul,Praneet Opanasopit,Tanasait Ngawhirunpat et al.
Akhayachatra Chinsriwongkul et al.
The aim of this study was to investigate the enhancement of all-trans retinoic acid (ATRA) loading in nano-lipid emulsions and stability by using oleic acid. The effect of formulation factors including initial ATRA concentration and the typ...