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Prefilled Syringes Trade Show San Diego 2022 and Device Testing Workshop

The 6th Annual Prefilled Syringes Conference is coming up fast! ZwickRoell is proud to sponsor this event. We provide key details below.

Prefilled Syringes San Diego 2022: Essential Details

The SMI Group’s Prefilled Syringes Conference will be held from 13th to 14th June, with a special workshop session dedicated to drug delivery device testing held on June 15th.

The event will be held at the Hyatt Regency Mission Bay Hotel in sunny San Diego California, located right on the coast at 1441 Quivira Road.

Attendees will get the opportunity to listen to industry speakers and case studies covering new innovations, regulatory updates, and insights into the future of this fast-evolving product market. For more detailed information on registration, hotels, speakers, and more, please see the SMI event website here or view the information sheet here.

ZwickRoell’s medical device testing team is excited to be a part of this event. Prefilled syringes and related drug delivery systems are a fast-growing market for a reason: they provide real opportunities to enhance patient health across a variety of applications.

Prefilled Syringes: A Fast-Growing Market with Critical Regulatory Challenges

Prefilled syringes are employed in a growing number of applications including dosing of anticoagulants, vaccines, therapeutic proteins, and biologics. They are also used to load autoinjector devices. In each application, prefilled syringes can deliver precise unit dose medication in a convenient, user-friendly format. Because prefilled syringes create new opportunities for patients to self-administer drugs at home (or otherwise away from the supervision of trained medical staff) they also introduce particularly robust regulatory requirements to ensure safe use.

For an interesting discussion on the state of the prefilled syringe market, including emerging trends and remaining challenges, we recommend this interview with industry executive Anil Kumar Busimi.   

These complex mechanical devices are prone to failure if they do not adhere to strict quality standards. Additionally, prefilled syringes are both a dosing device and a pharmaceutical storage system—the syringe itself must be carefully tested to ensure that no component is made from a material that could risk leeching into the stored pharmaceutical (or otherwise allow contamination during storage).

With these challenges in mind, rigorous adherence to ISO 11040 for prefilled syringes is an essential requirement to ensure safe, compliant products. This standard includes:

  • ISO 11040-4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)
  • ISO 11040-6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
  • ISO 11040-8: Requirements and test methods for finished prefilled syringes

ISO 11040 Syringe Testing: ZwickRoell Solutions for Prefilled Syringes

Prefilled syringe testing requires machines equipped with interchangeable test fixtures. This approach is necessary to accommodate both the complexity of syringe testing requirements, the diversity of syringe types, and the different materials used.

For glass barrel syringes, for example, all of the following tests are required through 10 annexes to the ISO 11040 standard.

  1. C1: Flange breakage resistance
  2. C2: Luer cone breakage resistance
  3. E: Glide force test method to evaluate syringe lubrication
  4. F: Needle penetration test
  5. G1: Needle pull-out force
  6. G2: Closure system liquid leakage test
  7. G3: Luer lock adapter collar pull-off force
  8. G4: Luer lock adapter collar torque resistance
  9. G5: Luer lock rigid tip cap unscrewing torque
  10. G6: Pull-off force of the tip cap or the needle shield

This high number of required tests (for just a single type of syringe design) demonstrates vividly why a flexible testing solution capable of supporting different testing procedures can be so valuable.

 

Learning More About Prefilled Syringe Testing Solutions

If you have an opportunity to attend Prefilled Syringes 2022 San Diego, we hope to see you there and encourage you to stop by our booth for a chat.

You can find a detailed event schedule and sign-up sheet in the downloadable PDF here.

If you’re unable attend, you can also find more detailed technical information on our testing solutions for prefilled syringes in our data sheet here. ZwickRoell also provides testing solutions for autoinjectors (you can find more information on testing standards and solutions here).

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