Testing of prefilled syringes | ISO 11040

Types of prefilled syringes (PFS) include glass or plastic, with or without needle:

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• Glass prefilled syringe: this material represents the highest level of experience in the industry, and still makes up the majority of prefilled syringe packaging today.
• Plastic prefilled syringe (polymer): the use of plastic syringes is growing due to advancements in polymer materials that have increased their biocompatibility with other syringe components.
• Needle-free prefilled syringe: these syringes are commonly used for vaccine products and include a Luer lock attachment for the needle, some type of tamper-proof element, and an elastomer plug at the nozzle of the syringe.
• Pre-filled syringe with staked-in needle: this type of syringe is typically used with biologic and pharmaceutical drugs and has the needle pre-attached (adhered) to the syringe.

As is the case with any tool used in the medical and pharmaceutical industry, the PFS is designed to meet the needs of the user, while maintaining strict standards of quality, efficacy, and safety. When compared to the traditional vial-syringe format, which is still widely used today, the PFS offers various advantages:

• Decreased contamination possibilities
• Decreased tendency to overfill
• Increased dosing accuracy
• Increased convenience
• Increased safety features

Along with, in some cases life-saving benefits, the PFS bears a multi-component complexity that includes a barrel, a needle, a needle shield, a plunger and a closure, all of which must interact seamlessly and safely with each other and with the pre-filled drug. In addition, the container closure integrity ( CCI), that is, the suitability of the syringe closure system, is of critical importance to maintain a sterile barrier against potential contaminants. Every version of the PFS is therefore strictly regulated by international standards and subject to testing.

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Testing Solutions for Syringe Testing

Drugs can be administered to the human body via many routes but perhaps the most common route is using hypodermic needles to inject the drug substances into the bloodstream. Although the popularity of non-invasive drug delivery systems is at rise, certain drugs such as insulin can only be administered to the body via medical needles.

ISO has provided the published standard ISO -1 defining general requirements for the quality, safety and performance of hypodermic syringes since . Manufacturers in the United States are also strictly controlled by the FDA as prescribed in 21CFR part 820. The general requirements for all hypodermic needle quality testing includes; gauging, leakage, needle insertion/penetration, and other mechanical test methods to ensure the end product.

ADMET offers multiple Universal Material Testing systems are configured to meet and exceed the ISO test standards set forth by ISO -1 and can be validated per FDA&#;s 21CFR part 11. All of the systems are controlled with ADMET&#;s proven MTESTQuattro testing software that automatically performs each test according to ASTM and ISO standards, as well as custom test procedures.

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