Pre-filled syringe testing and component evaluation support

Comprehensive, ISO compliant testing for pre-filled syringes and components, helping manufacturers ensure safety, performance and regulatory compliance in a rapidly growing global market. 

 

The use of pre-filled syringes is growing rapidly, driven by the rise in self-administration therapies, biologics and treatments for chronic diseases. As these devices bridge both the pharmaceutical and medical device sectors, they face increasing regulatory scrutiny and a complex approval pathway.


Performance, safety and regulatory compliance of pre-filled syringes are critical to product success. Device reliability and ease-of-use are key to patient adoption and brand success in an increasingly competitive market. Early identification of design or manufacturing issues can avoid costly recalls, delays and ensure brand reputation.

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P1046563 Syringe (1) P1046510

Depending on the prefilled syringe contents and the intended use global authorities such as the FDA and EMA require authorisation of the drug, combination product or medical device determined by the region of the market. That’s why we continue to invest in new instrumentation and expanded our expertise to deliver comprehensive, pharmacopeial and ISO-compliant (including ISO 11040, ISO 9626 and ISO 23908) testing for both finished devices and component parts.


RSSL utilise several state-of-the-art laboratories which closely collaborate to offer the essential pre-filled syringe testing either as a single technique or as a bespoke package supports clients at every stage of development, from R&D through to market release ensuring that pre-filled syringes meet global quality and safety expectations.

 

 

Our dimensional testing capabilities

 

Accurate measurement of critical syringe and needle dimensions such as total length, flange strength and Luer Lock compatibility using advanced non-contact Vision Measuring Machines (VMM) are detailed within the ISO-11040-4 for several syringe types. Detailed below are key measurements required for syringes with and without Luer Slip/ Luer Lock adapters;

 

 

Mechanical strength & resistance


The evaluation of how well a pharmaceutical container or delivery device can withstand mechanical stresses during manufacture, transport and storage and use is vital to regulatory compliance and patient safety.

  • This is a key regulatory requirement designed to confirm the mechanical strength of syringe barrels under stress. The test measures the force required to break the syringe flange when pressure is applied, simulating the mechanical load experienced during injection.


    RSSL has recently invested in a GMP-compliant Stable Microsystems TA and HD Plus C texture analyser, equipped with 100 kg and 500 kg load cells, extending our testing range and precision. This enhancement builds on our existing systems (30 kg and 100 kg load cells), enabling us to perform a wider variety of bespoke strength tests while supporting high-throughput programmes where multiple batches or syringe formats must be assessed.

     

    By validating flange strength early in development, manufacturers can reduce the risk of component failure during filling, transport, or use.  

  • This test evaluates the removal force required to detach protective caps or shields from pre-filled syringes. These tests simulate both manual use and automated autoinjector applications 
    Using customised texture analysers and adaptable fixtures, RSSL can perform pull-off testing at displacement rates between 100–1000 mm/min with 50–100 N load cells, ensuring accurate replication of real-use conditions. Alternative non-contact methods are also available to evaluate pull-out forces without pinching the shield or needle, minimising the risk of test-induced artefacts.

     

    This testing helps ensure optimal user experience, confirming that caps are secure enough to prevent accidental removal during transport but easy enough to remove during administration.

  • This test measures the force required for a needle to pierce standard materials, simulating the effort needed for injection. Using low-force texture analysers (under 10 N) and test speeds of 20–200 mm/min, we generate force-displacement profiles that reflect real injection conditions.


    In parallel, dimensional analysis is performed using our Vision Measuring Machine (VMM). This non-contact optical system captures critical needle and barrel dimensions such as outer diameter, length and bevel angle. Together, these tests confirm mechanical precision and device performance consistency.

  • This is vital to pre filled syringe performance testing due to the inner surface of many syringe barrels being lubricated, often with silicone oil to improve gliding properties. RSSL assesses the quality and consistency of the lubricant as per Eur. Ph. 3.1.8 and USP NF <<Dimethicone>>. At RSSL, siliconisation is checked using aluminium oxide powder methods in line with regulatory requirements.

  • This testing assesses the fixation strength between the needle and syringe barrel, verifying that the bonding process meets design and regulatory expectations. The syringe is mounted vertically within a texture analyser using either the finger flange or shoulder and a precision gripper applies a controlled tensile force to remove the needle or break the syringe.

     

    This test is suitable for both empty syringe barrels and sterile sub assembled syringes ready for filling. It provides assurance that needles remain securely attached during handling, sterilisation and use reducing the risk of detachment or leakage which could compromise sterility and patient safety.

  • This test assesses the integrity of syringe closure systems under conditions that simulate filling, handling and transport. It is used to determine whether the syringe can withstand overpressure or physical stress without leaking. Using our texture analysers, a test pressure of 110 kPa is applied to the plunger rod of a syringe, with the needle shield or tip cap still in place, for five seconds.

     

    The syringes are filled to one-third to two-thirds of its nominal volume. This verifies the robustness of the closure and seal, meeting both ISO and pharmacopeial requirements and is critical for maintaining sterility and preventing product loss.

  • This is used to evaluate the syringe usability and lubrication consistency needed to initiate and maintain plunger movement throughout shelf life. The tests are designed to empty syringe barrels for quality and consistency of lubrication or finished product prefilled syringe functionality, vital for ensuring smooth operation and consistent dose delivery. 


    RSSL performs this testing using temperature-controlled GMP texture analysers, matching the syringe’s intended conditions of use. Testing can be applied to both empty barrels (to assess lubrication quality) and finished pre-filled syringes (to confirm long-term performance across shelf life).

Additional Analytical Testing

 

To complement our mechanical testing services, RSSL also provides:

 

  • Hydrolytic resistance testing for glass barrels to ensure material suitability
  • Particulate testing in accordance with USP <788> to control subvisible particles in small-volume parenterals
  • Endotoxin and pyrogenicity testing to confirm sterility and product safety

 

Find out how we could support your pre-filled syringe testing

 

Through our investment in new technology and cross-functional expertise, RSSL offers one of the UK’s most comprehensive capabilities for pre-filled syringe and component testing. From early-stage design verification to commercial batch release, our laboratories deliver reliable, compliant data that help clients demonstrate safety, performance and regulatory compliance.

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