Syringe Testing to ISO 11040
ISO 11040 is a testing standard that addresses the design and functional properties of prefilled syringes. ISO 11040 is used primarily within the pharmaceutical industry and is critical for ensuring that syringes work properly in a clinical setting. ISO 11040 evaluations are performed throughout the manufacturing process to minimize any chance of defective equipment leaving the factory as failure of any subcomponent can have a major impact on either the physician or patient: an improper seal can cause oxidation of the drug and affect the shelf life of the product, while structural damage to the syringe barrel could lead to device failures. Note: Labs that manufacture syringes must be in compliance with 21 CFR Part 11.
NAVIGATING THE STANDARD
ISO 11040 is composed of 8 parts:
- Parts 1-3 refer to the subcomponents of cartridges used for local anesthetic in dental settings.
- Parts 4-6 refer to the subcomponents of prefilled syringe including glass barrels, plastic barrels, and plunger stoppers.
- Part 7 addresses the packaging systems typically used for pre-sterilized fill and finish applications. "Fill and finish" refers to the process of preparing the syringes for their end use, which is often a bottleneck in the supply chain.
- Part 8 outlines the test methods and evaluation criteria for the finished syringe rather than the individual subcomponents. These tests include durability of the syringe barrel, functional use of the devices (break loose and glide forces, needle penetration forces), and evaluation of the device closures and safety features. Many of the test methods outlines in part 4 and part 6 are analogous to those in part 8.
| ISO 11040 Test Setup Options | |
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6800 Series Universal Testing System
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Bluehill Universal Software
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2527 Series Biaxial Load Cell
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| Torsion Add-On 3.0 | |
| CP132121 Modular Test Fixture | |
AUTOMATION OPTIONS
Annex G.5 of ISO 11040 specifically assesses the removal torque of rigid tip caps used in conjunction with female luer lock connections. When used in conjunction with a torsion-enabled universal testing system, a cobot can be extremely beneficial for lab productivity - essentially functioning as a pick and place operation to reduce operator influence. The repeatability of automated specimen insertion is also ideal for improving device alignment, a significant contributor to data spread. Since prefilled syringes can come in a range of capacities, the sample racking can be customized to accommodate all potential device geometry, and the seamless integration with Bluehill Universal means test methods for new devices can be created quickly.
Tips and Tricks
- Though pre-filled syringes are primarily used within the pharmaceutical industry, these delivery systems can also be used with so called borderline products as well, which can include some non-medical chemicals like hyaluronic acid.
- To learn more about testing drug delivery and container testing, Click Here.
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最高クラスの6800シリーズ試験機のカタログ
インストロン6800シリーズ万能材料試験機は、他に類のない精度と信頼性を提供します。特許申請中のオペレーター保護機能に基づき、最新のスマートクローズエアキットおよび衝突緩和機能を搭載した6800シリーズは、材料試験をかつてないほどシンプルに、スマートに、安全にします。
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ISO 11040：薬剤充填済みガラス製注射器用の試験治具
インストロンは、ISO 11040の10種の附属書すべてに沿って試験を実施できるように設計された、モジュール式の治具を提供しています。
Torsion Add-On 3.0
Torsion Add-On 3.0は、軸方向およびねじり試験の両方を必要とする医療機器、電子機器、消費者製品、包装、自動車部品などの性能を測定するための簡素なソリューションを提供します。