行业组件数据 · 2026

穿刺区域

The designated area on a rubber stopper designed for needle penetration during pharmaceutical vial filling and administration.

技术定义与适配语境
典型 穿刺区域 会按材料、尺寸公差、适配关系和失效风险在 化学制造 中评估。

A precisely engineered zone on pharmaceutical vial rubber stoppers that facilitates sterile needle penetration while maintaining container closure integrity. This area is specifically designed to allow repeated punctures without compromising the seal or generating particulate matter, ensuring safe drug delivery and storage.

组件规格

定义
A precisely engineered zone on pharmaceutical vial rubber stoppers that facilitates sterile needle penetration while maintaining container closure integrity. This area is specifically designed to allow repeated punctures without compromising the seal or generating particulate matter, ensuring safe drug delivery and storage.
工作原理
The penetration zone operates by providing a controlled thickness and material composition that allows hypodermic needles to penetrate cleanly while the surrounding rubber material self-seals upon needle withdrawal. This maintains sterility and prevents contamination or leakage through elastic recovery and compression properties.
材料
Typically made from pharmaceutical-grade elastomers: bromobutyl rubber (BIIR)chlorobutyl rubber (CIIR)or synthetic rubber blends. Must meet USP <381> and EP 3.2.9 standards for elastomeric closures.
Diameter
13-20 mm
Hardness
40-50 Shore A
Thickness
1.5-3.0 mm
Resealability
≥5 punctures
Penetration Force
5-15 N
Particulate Matter
≤600 particles ≥10μm per vial
标准
ISO 8871ISO 8362USP <381>EP 3.2.9FDA 21 CFR Part 211

行业分类与别名

穿刺区域 的常用贸易名称、技术标识和检索关键词。

上级产品

该组件会出现在以下整机或工业产品中。

FMEA · 风险与缓解

诱因 → 失效模式 → 工程缓解

Improper needle geometry or insertion angle->Coring and particulate contamination->Use non-coring needles and standardized insertion protocols
Material degradation from sterilization or drug interaction->Loss of resealing capability->Validate material compatibility and sterilization cycles

工业生态与工程逻辑

0
Coring and particulate generation
1
Incomplete resealing leading to contamination
2
Leakage due to material fatigue
3
Chemical interaction with drug formulation

合规与检测

tolerance
±0.2 mm thickness, ±0.5 mm diameter
test method
USP <381> Elastomeric Closure Functionality, ISO 8871 Self-sealability test, Container Closure Integrity Testing (CCIT)

制造该组件的工厂

来自 CNFX 组件能力表的相关制造商资料。

制造商列表用于前期研究和供应商能力理解,不代表认证、排名或交易担保。

采购评估维度

不是客户评论,也不是实时热度。以下维度用于前期 RFQ 准备和供应商评估。

技术文档
4/5
制造能力
4/5
可检验性
5/5
供应商透明度
3/5

这些分值是采购评估维度示例,不代表真实客户评分、具体国家买家反馈或实时询盘。

相关组件

常见问题

How many times can a penetration zone be punctured?

High-quality penetration zones are designed to withstand 5 or more punctures while maintaining seal integrity, though single-use is recommended for optimal sterility.

What causes coring in penetration zones?

Coring occurs when needle design, angle, or rubber hardness causes small fragments to be removed during penetration. Proper needle geometry and optimized rubber formulation minimize this risk.

我可以直接联系工厂吗?

CNFX 是开放目录,不是交易平台或采购代理。工厂资料和表单用于帮助你准备直接沟通。

CNFX Industrial Component Index · 化学制造

数据基础

CNFX 制造商资料、技术分类、公开产品信息和持续合理性检查。

初步技术归类
本页用于结构化准备研究、RFQ 和供应商评估,不替代买方自己的供应商资质审查、标准核验和技术批准。

请求制造能力信息: 穿刺区域

说明目标数量、应用场景、交期和关键技术要求,用于准备 RFQ 或供应商评估。

谢谢,信息已发送。
谢谢,信息已收到。

需要制造 穿刺区域?

对比具备该组件加工或装配能力的制造商资料。

创建制造商档案 联系我们
上一个组件
空气入口集气室/管道
下一个组件
穿孔板
URN:CNFX:ME:UNIT:PENETRATION_ZONE