参照 ISO 11040-4 的预充式注射器类型与组件检测项目简介

相较于西林瓶（vial），预充式注射器（PFS，Prefilled Syringe）用于无菌制剂灌装时有着较多的优势，比如：护士或者患者可以直接注射给药，操作方便的同时也降低了药液抽取、转移过程中的无菌风险。本文参照ISO-11040-4 "Glass barrels for injectables and sterilized subassembled syringes ready for filling (ver. 2024)" ，对PFS做一些简单的介绍。

PFS的类别：

PFS可以分为二大类：带针头（staked needle syringe）和带鲁尔头（Luer slip syringe），相关示意图如下：

PFS类型示意图

l Syringes with Luer cones (鲁尔滑配式注射器) are closed with a tip cap (护帽) of an appropriate elastomeric material. The seating of the tip cap is ensured by static friction (摩擦力) between the socket cone of the tip cap and the cone of the glass syringe and can be improved by ceramic coating(陶瓷涂层) or roughening (粗糙) of the cone surface.示意图参见a)

l Syringes with Luer lock cone (鲁尔锁定式注射器) are closed with a tip cap of an appropriate elastomeric material. These tip caps can be embedded in rigid housings which are connected to the Luer lock adapters. The Luer lock adapter is snapped onto the 6 % Luer slip. These rigid syringe closure systems are available with or without tamper evidence (防揭功能) in various designs.示意图参见b)

l Syringes with a staked needle (带针头注射器) are closed with a needle shield(护帽) or a rigid needle shield. The needle tip, and particularly the opening of this tip, shall completely be embedded into the elastomer of the needle shield to ensure sealing. 示意图参见c)

PFS的特殊检测项目：

l Flange breakage resistance法兰刚性

The test is used to determine the flange breakage resistance by applying a force on a syringe barrel that has been placed in a cylinder holder under the flange.

法兰刚性测试装置示意图

法兰刚性测试曲线示意图

l Front end breakage resistance 前端刚性

During standard usage and handling of syringes one weak point can be the front end of the syringe that can be charged by a side load and lead to breakage.

前端刚性测试装置示意图

l Glide force 启动力/滑动力

This test method is used to measure either the gliding force of empty syringe barrels to assess the quality and consistency of the, for example, silicone oil lubrication within the inner syringe barrel or to measure the glide force of non-lubricated syringes in combination with plunger stoppers acting as lubrication. 滑动力测试既可以用于检测评估玻管内壁硅化质量和均一性，也可以用于检测评估密封完整性组件的功能指标。The quality and consistency of the lubrication performance can be dependent on the test speed used.

滑动力测试曲线示意图

一般报告启动力（使得胶塞开始移动时的力）和平均滑动力这二个结果：

启动力Fs：Force required (Fₛ) to initiate the movement of the plunger.

滑动力F：Mean force (F) during the plunger travel.

l Needle penetration test 穿刺力测试

This test method is used to determine the needle penetration force by piercing a test foil (铝箔) with a needle.

针头穿刺力测试示意图

针穿刺力测试曲线示意图

lNeedle pull-out force 针拔出力

The test is used to assess the fixation of the needle to the syringe. It is mainly designed to verify whether the needle bonding process is appropriate to show that the staked needle withstands the pull-out force.

针拔出力测试装置示意图

l Syringe closure system liquid leakage test 注射器密封系统液体泄漏测试

The test is used to assess the liquid leakage resistance of the syringe closure systems (needle shield or tip cap) assembled onto the syringe. It is mainly designed to verify whether the syringe closure system is able to withstand any potential overpressure inside the syringe during the filling process or during transportation. The test pressure of 110 kPa has been selected based on process conditions during the fill finish process. 用于检测和评估护帽的抗压力能力（防止液体泄漏）。

注射器密封系统抗液体泄漏测试装置示意图

l Luer lock adaptor collar pull-off force 鲁尔锁定适配器套环拔出力

The test is used to assess the pull-off force of a Luer lock adaptor (LLA) collar system of sterilized subassembled syringes ready for filling. It is mainly designed to verify whether the LLA collar system is able to withstand an axial pull-off force in order to avoid detachment(分离) of the LLA collar system from the syringe barrel by the insertion of a socket 6 % (Luer) conical lock fitting.

鲁尔锁定适配器套环拔出力测试装置示意图

l Luer lock adaptor collar torque resistance 鲁尔锁定适配器套环扭矩测试

The test is used to assess the torque resistance of an LLA collar system of a sterilized subassembled syringe ready for filling. It is mainly designed to verify whether the LLA collar system is able to withstand an applied torque while inserting a socket 6 % (Luer) conical lock fitting (i.e. needle hub).

鲁尔锁定适配器套环扭矩测试装置示意图

l Luer lock rigid tip cap unscrewing torque 鲁尔锁式护帽旋开扭矩

The test is used to assess the torque of a rigid tip cap of a sterilized subassembled syringe ready for filling. It is mainly designed to verify whether the rigid tip cap can be removed from the syringe with a reasonable torque.

鲁尔锁式护帽旋开扭矩测试装置示意图

l Pull-off force of the tip cap or the needle shield 护帽拔出力测试

This test is used to assess the removal force of the tip cap or the needle shield of a sterilized subassembled syringe ready for filling. This method can be customized depending on the intended use of the syringe (e.g. manual use, use in an auto-injector).

护帽拔出力测试装置示意图