The Definitive Guide to Syringe Testing Per ISO 11040 & ISO 7886
Within the pharmaceutical industry, mechanical testing is mainly comprised of primary containers and combination products. The most common application by far is testing required for syringes. While simple in design, the number of functional and usability tests required can be overwhelming for labs new to these kinds of evaluations. This definitive guide aims to identify the key metrics to assess syringe performance, the most common standards followed internationally, and the ideal fixturing for various syringe types.
Learn more about drug delivery device testing.
[00:00:10] Speaker: No biomedical device is as ubiquitous as the common syringe.
[00:00:14] Speaker: Despite its apparent simplicity, there are many design elements that must be taken into consideration to ensure that syringes perform optimally.
[00:00:22] Speaker: As a result, extensive product testing is needed before a syringe can be released into the market.
[00:00:28] Speaker: Break loose and glide force testing is the most fundamental type of mechanical test that must be performed on all syringes.
[00:00:36] Speaker: This test simulates the real-world use of the device in order to quantify the break loose force, or the force required to initiate plunger travel, and the glide force, or the force required to sustain movement of the plunger.
[00:00:49] Speaker: Break loose and glide force testing is often defined by internal design verification procedures or by standards like ISO 11040 for glass syringes and ISO 7886 for plastic syringes.
[00:01:03] Speaker: A universal syringe fixture allows you to accommodate a wide range of syringe diameters without requiring separate components.
[00:01:10] Speaker: The self-centering design also ensures that the device alignment is repeatable between tests.
[00:01:16] Speaker: In cases where dispensed volume is being evaluated, precision balances can be incorporated and integrated within Bluehill® Universal software.
[00:01:25] Speaker: ISO 11040 includes multiple annexes outlining functional tests of glass syringes that evaluate the barrel strength, staked needle, plunger forces, and closure integrity.
[00:01:37] Speaker: This suite of tests can be performed using a modular set of fixtures, designed to minimize setup time between tests and guarantee operator safety by utilizing guarding to protect from glass breaks.
[00:01:49] Speaker: Because plastic syringes have fewer failure modes than glass, ISO 7886 has fewer requirements than ISO 11040.
[00:01:58] Speaker: Updated in 2017, ISO 7886 simplifies the plunger force method to be more in line with ISO 11040.
[00:02:06] Speaker: This standard specifically calls out the medium, tubing, and needle gauge when performing the test to better compare results between devices.
[00:02:15] Speaker: ISO 7886 also incorporates closure integrity testing via application of a side load to the syringe plunger and visual inspection of leakage points.
[00:02:26] Speaker: To address the high risk of fingerstick injuries during syringe use, many combination products are being developed that introduce passive safety mechanisms to syringes.
[00:02:35] Speaker: These safety syringes will incorporate spring-loaded mechanisms to automatically retract the needle after use. In addition to plunger force testing, they will also undergo safety lockout or defeat force testing, which confirms that the lockout mechanism cannot be overridden by the user.
[00:02:53] Speaker: In labs where staffing resources are constrained, automation can be utilized to reduce reliance on test operators.
[00:03:00] Speaker: Depending on the specific application, Cobots or XY stages can be leveraged to improve lab efficiency.
[00:03:07] Speaker: To learn more about the mechanical testing of biomedical devices, visit our website.
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