The market for prefilled syringes (PFS) continues to grow. They are used for a wide variety of applications, from anticoagulants and biologics to autoinjectors. However, these devices are prone to failure due to their complex action mechanics and sensitivity to storage. They are therefore strictly regulated by international standards.
Syringe testing to ISO 11040 – Prefilled syringes is critical for safe dispensing of medications, anticoagulants and biologics. To meet the strict requirements of the annexes to the standard, the testing machine to be used must be equipped with a wide variety of interchangeable test fixtures that can accommodate a multitude of syringe types. Some of these tests also require a superimposed torsion drive.
ZwickRoell offers the right testing system for standardized syringe testing on prefilled syringes to EN ISO 11040 (ISO 11040-4, ISO 11040-6, ISO 11040-8) Thesetests are also referenced in USP (United States Pharmacopeia) Chapter <1382> and <382>.
- Die ISO 11040-4, ISO 11040-6 und ISO 11040-8 werden referenziert im United States Pharmacopeia USP <1382>
Das Kapitel <1382> enthält Informationen und Anleitungen zur Unterstützung bei der Bewertung der funktionalen Eignung von Elastomerkomponenten als Teil von Verpackungs-/Arnzeimittelabgabesystemen, die für parenterale Darreichungsformen vorgesehen sind.
- Desweiteren werden die ISO 11040-4 und ISO 11040-8 referenziert im USP Chapter <381>. Das Kapitel <382> behandelt die Anforderungen an die funktionelle Eignung von Verpackungs-/Arzneimittelabgabesystemen, die für parenterale Darreichungsformen bestimmt sind.
Was bedeutet USP (United States Pharmacopeia)?
The ISO 11040-4 standard has ten annexes, in which the required mechanical tests are described:
- C1: Flange breakage resistance
- C2: Luer cone breakage resistance
- E: Glide force test method to evaluate syringe lubrication
- F: Needle penetration test
- G1: Needle pull-out force
- G2: Closure system liquid leakage test
- G3: Luer lock adapter collar pull-off force
- G4: Luer lock adapter collar torque resistance
- G5: Luer lock rigid tip cap unscrewing torque
- G6: Pull-off force of the tip cap or the needle shield
The interchangeable test fixtures are ideal for various syringe types and ensure that the testing of prefilled syringes is standardized.
As a manufacturer of materials testing machines, ZwickRoell offers a complete product portfolio for testing to ISO 11040. With interchangeable testing adapters, the solution can be effortlessly adapted to different types of syringes and ensures that testing of prefilled syringes is standardized. The zwickiLine is the ideal single-column testing machine for this application, designed for testing with low forces up to 5 kN.
- Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
- With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
- Integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from tampering.
- Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.
- ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
- testXpert III logs all test and system related actions and settings and can therefore always answer the question “When does who do what, why and who is responsible?”
Learn more about the testXpert III option