Test Tools for the Medical Industry

All safety-critical tests, such as those in the pharmaceutical and medical engineering industries, have special requirements on traceability and documentation. testXpert III ensures that the test results are always protected against tampering and that all changes and test results are traceable.

Learn more about traceability in testXpert III

• Applications: The test fixture is used to determine the plunger glide force of sterile single-use syringes made from plastic and other materials for medical purposes, with fluid contents (water) to EN ISO 7886-1 Annex E (2017).
• Function description: The test fixture consists of an upper and a lower clamping device to hold the syringe and a height-adjustable fluid reservoir. When testing, the plunger rod of the syringe can be loaded in both tensile and compression directions.

  During the test, the fluid in the filled syringe is expelled into the reservoir via a standard needle (18G). The needle is connected to the hose via a Luer connector. During the test, the plunger travel, the breakaway force, as well as the maximum and the average glide force are recorded and evaluated via ZwickRoell testing software. The test speed is 100 ±5 mm/min.

• Advantages:
  • The fixture includes all components required by the standard (holders, reservoir, hose with adapters).
  • The clamping devices accommodate syringes with a diameter of 6 to 33 mm
  • High accuracy
  • ZwickRoell's testing software combined with the Traceability option fulfills the requirements according to the ZwickRoell FDA 21 CFR Part 11 whitepaper

• Applications: The needle puncture test fixture is used to determine the puncture force of needles to ISO 11040-4. Typical medical applications are, for example, puncture tests on skin replacement material or penetration tests on standard films.
• Function description: The needle puncture test fixture consists of a base body with a swivel able specimen holder.

  The material to be punctured is gripped in the specimen holder. The test angle can be set to four different angles by means of a lock-pin.

• Advantages:
  • Variable test angle to test axis; can be locked at 30 °, 45 °, 60 ° and 90 °
  • Needles with a diameter up to 8 mm or injection needles and other connectors with Luer cones can be mounted in the optionally available holders
  • ZwickRoell's testing software combined with the Traceability option fulfills the requirements necessary for compliance with all FDA 21 CFR Part 11 criteria

• Applications: The test fixture is used to determine the breakage force of the finger flange of prefilled syringes. In Annex C1 of the standard the breakage resistance of the finger flange is tested. To perform the test the glass syringe is inserted into the support disc of the universal mount. 
• Advantages:
  • The same test fixture can also be used for Annex E and G2
  • Adjustable mount for different syringe volumes with varying diameters and lengths
  • Quick-release fastener for fast specimen changes

• Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex E of the standard the glide force of the syringe without protective cap is tested.

  Annex G2 describes the leakage test on a filled syringe with attached protective cap. The plunger is pressed to the shoulder of the syringe at a defined force and speed.

• Advantages:
  • The same test fixture can also be used for Annex C1
  • For syringes with Ø 6 / 8,2 / 11 mm
  • Adjustable syringe mounting for different syringe diameters and lengths
  • Quick-lock system for secure holding

• Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex G1 of the standard the strength of the needle bonding (needle pull-out force) is tested.

  To perform the test, the glass syringe is gripped with the lower pneumatic grip. The aligned syringe needle is gripped with the special jaws of the upper pneumatic grip and pulled off upwards at a defined speed.

• Advantages:
  • Versatile pneumatic grips that can also be used for Annex F, G3 and G6
  • Special corrugated jaws with plane surfaces for optimum load application
  • Secure gripping of sensitive specimens through adjustable gripping pressure

• Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex G6 of the standard, the pull-off force of the needle shield (tip cap) is measured. To perform the test, the glass syringe is gripped with the lower pneumatic grip, Fmax 500 N.

  The needle shield (tip cap) is pulled axially upwards off the glass syringe with the 3-Jaw chuck. The test speed is between 100 mm/min and 1000 mm/min. The pull-off force and the pull-off distance are measured and recorded.

• Advantages:
  • Versatile pneumatic grips that can also be used for Annex F, G1, G3, G4 and G5
  • Secure gripping of sensitive specimens through adjustable gripping pressure

• Applications: Indirect residual seal force on medical vials. This includes the residual seal force (RSF) is the force with which the rubber stopper between the flanged cap and the neck of the vial is braced. This force measurement indicates the security of the vial closure. However, these measurements must be correlated with established tests that examine the seal integrity of the stopper.
• Advantages:
  • The fixture consists of a retaining plate for supporting the vial. The integrated prism serves as a centering aid with a scale used to read a vial diameter of 6 mm to 70 mm.
  • Fixture available with inserts and compression dies of various diameters (8.0 mm; 13.8 mm; 20.7 mm; 28.5 mm; 32.94 mm). For the respective test, the die diameter should correspond with the protective cap diameter.
  • A modular design allows the various inserts to be changed quickly and easily.
  • an upper compression test kit with locking nut for pre-positioning the die holds the compression die.
  • Load is applied via a ball joint to compensate for deviations from parallel up to approximately 1°.
  • Collection tray for liquid.
  • Use only in conjunction with a safety device.