Prefilled Syringe 测试

Prefilled syringes are a popular drug delivery device, providing a reliable and safe solution that delivers an exact dose of a pharmaceutical product. With extensive experience testing a variety of syringes for functionality and integrity, im体育APP can help you successfully navigate regulatory requirements for testing prefilled syringes.  

While prefilled syringes can be used as standalone drug delivery systems, they are also often used in autoinjectors. Prefilled syringes and needle-based injection systems have multiple components that must be evaluated for functionality and integrity. There are several types of prefilled syringes, including glass filled syringes, plastic prefilled syringes or needle free (luer lock) syringes. im体育APP’s 医疗设备 experts verify the safety of prefilled syringes and autoinjector components with both standard and non-standard test methods. Looking to talk about your syringe testing needs? 与专家交谈. 

Industry test standards for prefilled syringes 

ISO 11040, which consists of 8 parts, evaluates the mechanical properties of these syringes and tests to ensure the device performs properly when components are exposed to different forces. There are also several other standards and regulatory guidance documents that outline functional syringe testing related to mechanical specifications, 包括ISO 7886, ISO 8537 (syringes for insulin use), and ISO 11608 (autoinjectors).

另外, ISO 7886 specifics the test methods for evaluating empty sterile hypodermic syringes, both with and without the needle. im体育APP offers prefilled syringe testing to these International Organization for Standardization (ISO) methods and will assist in developing test protocols for your delivery system to support regulatory submissions and safe product use. 请求报价 from im体育APP’s syringe testing lab today.

Mechanical syringe testing

测试 syringes to ISO 11040 is critical to ensuring drugs are administered to patients safely. im体育APP’s ISO 11040 syringe testing services include the following tests:

圆凸缘

• C1: Flange breakage resistance

鲁尔接口锥

• C2: 鲁尔接口锥 breakage resistance

柱塞塞

• E: Glide force test method to evaluate syringe lubrication

针

• F: 针 penetration test
• G1: 针 pull-out force

适配器领

• G3: Luer lock adapter collar pull-off force
• G4: Luer lock adapter collar torque resistance

尖帽

• G5: Luer lock rigid tip cap unscrewing torque

针盾

• G6 – Pull off force of the shield
• G7 – Closure system liquid leakage

im体育APP优势

Mechanical properties of syringes are tested to ensure the device performs properly when exposed to different forces. Ensure the safety of prefilled syringes and autoinjector devices when you partner with im体育APP’s 医疗设备 experts for mechanical syringe testing.

For more information about our needle-based injection system testing services or to request a quote, 立即im体育APP.