Syringe testing is a critical step in developing and commercialising needle-based injection systems for medical use. As per recent FDA guidelines testing of filled syringes (combination of the syringe and the drug product) must be subjected to release testing at the site where filling will be completed as part of incoming quality control efforts. By testing mechanical properties, such as break-loose and glide force, we can determine if the device is within standard specifications, reducing the likelihood of improper function.
The Texture Analyser can be applied to the testing of prefilled syringes in many ways according to ISO 11040-4 and ISO 11040-8 standards. The individual test methods are for “Glass barrels for injectables and sterilized sub-assembled syringes ready for filling” according to ISO 11040-4 standard, and “Requirements and test methods for finished prefilled syringes” according to ISO 11040-8 standard. Based on the needs and feedback from many of our current customers, we have designed and developed a portfolio of standard-compliant test attachments to ensure we offer a wide range of up to date solutions for prefilled syringe testing.
Are you ready with the testing solutions?
In this video let us guide you through the portfolio of interchangeable solutions for these standard methods that are ideal for many syringe types and ensure standardised testing of prefilled syringes.
In summary, prefilled syringe testing on a Texture Analyser now covers the following test methods:
- Flange break resistance testing (ISO 11040-4 Annex C1) and (ISO 11040-8) - used to determine the flange breakage resistance by applying a force on a syringe barrel that has been placed in a cylinder holder under the flange.
- Luer cone breakage resistance testing (ISO 11040-4 Annex C2) - used to determine the strength of the cone that is determined by the geometry and glass characteristics like residual tension.
- Syringe glide force testing (ISO 11040-4 Annex E1) and Break loose and extrusion force (ISO 11040-8) - used to measure the gliding force of empty syringe barrels to assess the quality and consistency of silicone oil lubrication within the inner syringe barrel.
- Needle penetration force testing (ISO 11040-4 Annex F1) and (ISO 11040-8) - used to determine the needle penetration force by piercing a test foil with a needle.
- Needle pull-out force testing (ISO 11040-4 Annex G1) and (ISO 11040-8) - used to assess the fixation of the needle to the syringe.
- Luer lock adapter collar pull-off force testing (ISO 11040-4 Annex G3) and Closure system forces - (ISO 11040-8) used to assess the pull-off force of a Luer lock adaptor collar system of sterilised sub-assembled syringe ready for filling. It is designed to verify whether the collar system is able to withstand an axial pull-off force in order to avoid detachment of the collar system from the syringe barrel.
- Pull-off force testing of the tip cap or the needle shield (ISO 11040-4 Annex G6) - used to assess the removal force of the tip cap or the needle shield of a sterilised sub-assembled syringe ready for filling.
There is a Texture Analysis test for virtually any physical property. Contact Stable Micro Systems today to learn more about our full range of solutions.
For more information on how to measure texture, please visit the Texture Analysis Properties section on our website.
The TA.XTplusC Texture Analyser is part of a family of texture analysis instruments and equipment from Stable Micro Systems. An extensive portfolio of specialist attachments is available to measure and analyse the textural properties of a huge range of food products. Our technical experts can also custom design instrument fixtures according to individual specifications.
No-one understands texture analysis like we do!
Get in touch to discuss your specific test requirements
|
No comments:
Post a Comment