Testing Machines and Testing Systems for the Medical and Pharmaceutical Industry Intelligent Testing

1 The ZwickRoell Group Contents 1.1 Passion and expertise 1.2 Trusted partner for the medical and pharmaceutical industries 2 Therapy Systems 2.1 Tests on injection systems 2.2 Tests on injection pens 2.3 Fully automated tests on injection systems 2.4 Tests on syringes 3 Catheters and Stents 3.1 Tests on catheters 3.2 Tests on stents 4 Biomechanics 4.1 Tests on hip implants 4.2 Tests on spinal column implants 4.3 Tests on knee implants, osteosynthesis implants and screws 5 Dental Industry 5.1 Tests on dental implants 5.2 Tests on dental ceramics 6 Latex, Rubber and Silicone Products 6.1 Tests...

1.1 ZwickRoell—Passion and expertise Our company philosophy is founded on a passionate commitment to our customers. We work hard to ensure customer satisfaction by having over a third of our employees engaged in service and support. Fig.1. Reliable test results with machine and software solutions from ZwickRoell As a family-owned company with a tradition stretching back 160 years, we place great value on honesty and fairness. Over the years an ethos of close collaboration based on mutual trust between our partners, suppliers and customers has evolved, something that we all value highly. The basis...

1.3 ZwickRoell—a trusted partner for the medical and pharmaceutical industries Reliable test results in R&D, quality control and production Accurate and reliable test results are an important foundation in all development stages of automobiles and components. Testing solutions from ZwickRoell deliver accurate, repeatable, reproducible and traceable test results. Quality management The various statutory requirements, including the Medical Device Regulation (MDR), or regulations such as FDA 21 CFR Part 11, are implemented in full by ZwickRoell. For manufacturers and institutes our testing instruments...

Intelligent testing solutions—the right product for every application ZwickRoell's wide range of testing systems features modular design, enabling optimum adaptation to testing requirements. We provide varied testing solutions, from standard-based tests to materials testing machines for a variety of testing situations to complex, fully automated testing systems. All ZwickRoell testing systems are synonymous with reliable test results, simple operation and a high level of availability. From therapy systems to medical research—testing solutions for all segments As well as testing systems for the...

2 Therapy Systems 2.1 Tests on injection systems Injection systems include items such as syringes, needles, autoinjectors and injection pens with fixed and variable dosing. ISO 11608-1 describes the basic requirements for injection systems. 2.1.1 Tests on autoinjectors (ISO 11608-5) An autoinjector is a medical device for administering liquid medications and is therefore subject to stringent quality checks. The correct injection at the right dosage is critical in achieving a successful outcome to medication therapy, leading pharmaceuticals manufacturers to strive for a high level of automation...

Testing systems for this are available from ZwickRoell, enabling automated testing as follows: Other options include active tracking of the plunger and a retractable needle; an HD camera can additionally be integrated to record fluid expulsion. These recordings can then be stored traceably with the test results. The machine can also optionally be equipped with monitoring systems to comply with the requirements of EN ISO 13849. Control and evaluation of these additional functions and of the complete test sequence is via ZwickRoell's testXpert III testing software. 2.1.2 Simulation and characterization...

Testing autoinjectors: overview Injection time measurement, effective needle length, volume of medication ejected, identification of last drops Click-detection via microphone during injection Needle tip error analysis using HD camera Safety cap removal force/torque assurance tests on insulin pens and cartridges is ISO 11608 Parts 1 and 3. A testing system with additional torsion drive is required for these tests; this allows the various pen functions such as dose pre-setting, actuation force, stroke and actual dose to be measured in a continuous sequence. Pen needles can also be tested to ISO...

The ZwickRoell Group 2.4.1 Test on finished syringes as per ISO 11040 Parts 4 and 8 Fig. 2. Fully automatic testing system for insulin pens Some tests require a testing machine with additional torsion drive. The universal test device for syringes can also be used for tests on cartridges by means of suitable adapters. Torsion and leakage tests are described in ISO 80369. ISO 11040 covers pre-filled syringes. Parts 4 (Glass barrels for injectables and sterilized sub-assembled syringes ready for filling) and 8 (Requirements and test methods for finished pre-filled syringes) describe ten mechanical...

Overview of tests C1. Flange breaking resistance C2. Luer cone breaking resistance E. Glide-force test 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 tip cap or needle shield 2.4.2 Piston operating force, EN ISO 7886-1 Device for determination of the piston operating force for sterile single-use syringes as per EN ISO 7886-1. 2.4.3 Serial and parallel tests on...

An injection needle consists of a tube in various lengths and inside and outside diameters which is beveled and ground at one end and can be held in various ways at the other end. Fig. 2. Parallel testing of syringes lengthy period. To reduce the testing time the testing machine can be upgraded to 6-8 test axes with the corresponding number of load cells. This enables individual force recording for each syringe. easy determination of torques under static axial load. Fig. 1. Serial testing of syringes The resistance to breakage of injection needles is determined in a twopoint flexure test as per...