Testing of prefilled syringes | ISO 11040

The evaluation of prefilled syringes (PFS) encompasses various types, such as those made from glass or plastic, with the inclusion of or exclusion of a needle:

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• Glass prefilled syringe: Recognized for its longstanding experience in the industry, glass syringes continue to dominate the prefilled syringe packaging sector.
• Plastic prefilled syringe (polymer): With advancements in polymer science, plastic syringes are increasingly favored due to their improved biocompatibility with various syringe components.
• Needle-free prefilled syringe: These types are commonly utilized for vaccine delivery, featuring a Luer lock attachment for needles, a tamper-proof element, and an elastomer plug at the syringe's tip.
• Pre-filled syringe with staked-in needle: Generally employed for biologic and pharmaceutical applications, these syringes are characterized by having a needle that is pre-attached to the syringe body.

PFS tools, akin to all medical and pharmaceutical instruments, are designed to cater to user requirements while adhering to rigorous standards of quality, efficacy, and safety. In comparison with the conventional vial-syringe method, which is still prevalent, PFS offers several noteworthy benefits:

• Reduced potential for contamination
• Lower risk of overfilling
• Enhanced dosing accuracy
• Greater convenience
• Improved safety features

While providing life-saving benefits, the PFS encompasses complex components, including a barrel, needle, needle shield, plunger, and closure, all of which must work together seamlessly. Furthermore, the integrity of the container closure ( CCI) is crucial to ensuring a sterile barrier against contaminants. Each variant of the PFS is thus stringently regulated by international standards and subjected to comprehensive testing.

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Solutions for Syringe Evaluations

Various methods exist for administering medications, with the injection of drugs directly into the bloodstream via hypodermic needles being one of the most prevalent. While there is a growing trend towards less invasive drug delivery systems, certain medications, such as insulin, necessitate the use of medical needles.

The ISO has established standards, notably ISO 11040, that outline the essential requirements for the quality, safety, and performance of hypodermic syringes. In the United States, manufacturers are also subject to stringent regulations by the FDA, as described in 21CFR part 820. General quality testing for hypodermic needles encompasses aspects like gauging, leakage tests, needle insertion/penetration assessments, among others, to ensure product reliability.

ADMET provides multiple Universal Material Testing systems that are specifically designed to comply with ISO 11040 testing standards and can also be validated per FDA's 21CFR part 11. Each of these systems is facilitated by ADMET's robust MTESTQuattro testing software, which automates the execution of various tests in accordance with ASTM and ISO standards, along with tailored testing protocols.

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