Effects of Gamma Irradiation on Elastomeric Closures
伽马射线对橡胶容器的作用影响
Table of Contents 内容列表（目录）
MISSIO任务 S1
INTRODUCTION 绪论 S1
EXPEJXIMENTAL DESIGN 实验性设计 S1
PHASE I-ELASTOMER SCREENING STUDY 人造橡胶的筛选研究 S2
Materials and Methods 材料和方法
1. Elastomers 人造橡胶
2. Gamma Irradiation 伽马射线
3. Test Methods 测试方法
a) tensile strength 抗张强度
b) elongation at阅读故事
break 断裂伸长率
c) modulus 系数
PHASE 11-ELASTOMER PERFORMANCE EVALUATION
第二阶段----人造橡胶的性能评估
Materials and Methods 材料和方法
1. Elastomers 人造橡胶
2. Gamma Irradiation 伽马射线
3. Test Methods 测试方法
a) chemical tests 化学测试
-turbidity 浑浊度
-reducing agents 还原剂
-heavy metals 重金属物
-pH change PH值
-total extractables 全部萃取物
b) physical tests 物理测试
-crosslink density 耦合密度
-durometer measurement 硬度测量
-compression t 压缩应变
-surface characteristics 表面特征
-viscoelasticity 粘弹性
c) u related tests 应用相关的测试
-coring 取芯
-coefficient of friction 摩擦系数
-tackiness 黏滞性
-needle penetration force 穿透力
4. Results 结果
a) chemical tests 化学测试
b) physical tests 物理测试
-crosslink density 耦合密度
-durometer measurement 硬度测量
-compression t 压缩应变
-surface characteristics 表面特征
-viscoelasticity 粘弹性
c) u related tests 应用相关的测试
-coring 取芯
-coefficient of friction 摩擦系数
-tackiness 黏滞性
-needle penetration force 穿透力
TABLES 表格
I. PDA Irradiation of Rubber Formulations 合成橡胶的配方的辐射PDA
I-A. Formulation Ingredient Details 配方原料的详细资料
11. PDA Irradiation of足球赛新闻稿
Rubber Formulations 合成橡胶的配方的辐射PDA
-Physical Properties 物理属性
111. Pha I1 Elastomer Formulations 第二阶段的人造橡胶配方
IV. Dosimetry Summary Stoppers and Discs 瓶塞和圆盘的测试放射剂量概要
V. Stopper Durometer Hardness Study 瓶塞硬度的研究
VI. DMA Viscoelasticity DMA粘弹性
FIGURES 图解
1. Dumbbells for Physical Tests 哑铃状的物理测试效果图
2. 20mm Stopper 20mm的瓶塞
3. Typical Rheometer Curing Curve 典型的固化的流变曲线
4. Compressiion Set Plugs 压缩应变测试的效果图
5. Closure discs for DMA 用于DMA的封闭塑料圆盘
6. Compression Set Device 压缩应变测试的设备
7. Closure Disc Cut for DMA 用于封闭塑料圆盘的切片
8. Turbidity 浑浊度
9. Reducing Agents 还原剂
10. pH shift PH值
11. Total Extractables 全部的萃取物
12. Crosslink Density 耦合度
13. Durometer Measurement Manually Held Stoppers
14. Compression Set 压缩应变
15. Coring 取芯
16. Coefficient of Friction 摩擦系数
17. Needle Penetration Force 穿透力
APPENDICES 附录
I. Stopper Durometer Test Procedure 瓶塞硬度的测试流程
11. Needle Penetration Force Test Procedure 穿透力的测试流程
INTRODUCTION 绪论
Traditionally dry or wet heat, or chemical sterilants such as ethylene oxide. However, heat nsitive polymeric packaging materials or drug products cannot tolerate autoclaving or dry heat sterilization. Disposal of ethylene oxide and its toxic degradation products is a growing concern with the environmentally conscious and aeration of the chemicals from the sterilized product requires time consuming handling procedures. As a result, radiation sterilization has incread in popularity as a sterilization process for medical devices, pharniaceutical process and packaging. Yet even with the wide acceptance of radiation sterilization, consideration must be given to the medicament as well as the package to ascertai词语两个字
n whether or not any deleterious effects have occurred as a result of irradiation。
