Product & Materials Testing

Product and materials testing

Cryopak’s Product Testing Department assists manufacturers and engineers in a variety of industries by testing product performance and safety. Specializing in testing of medical devices such as Luer fittings, syringes, needles, catheters, guidewires, cannulae and electrosurgical instruments, this division tests to ASTM, IEC, ISO, JIS, EN and other accepted industry standards. Vibration, physical shock, thermal shock, friction, flow rate, force to operate, leakage and compression testing are among the many tests that can be carried out to help medical device developers better understand their product. Custom test development and protocol creation can also be provided.

Companies in a variety of industries use our wide range of testing services for one-stop package, product and materials testing in order to prepare for regulatory agency submission.

To complement its package testing, Cryopak’s Materials Testing Department takes design understanding to a deeper level by testing and evaluating the materials that make up the package itself. From tensile and tear testing of poly films and trays to applying compression and tension to packaging components, materials testing can increase a packaging engineer’s understanding of available options, allowing for more informed design decisions.

Processing variables, vendor changes, effects of aging, different sterilization treatments and material changes can be explored through material testing. The engineering staff at Cryopak has a thorough understanding of today’s test standards and the principles behind them.

Needle-Based Injection Systems

Needle injection systems, or auto injectors, are used in a wide variety of applications where a drug or biologic product needs to be delivered via injection – typically either subcutaneously or intramuscularly. The performance requirements for injector pens and needles as defined in the ISO 11608 standard must be met before products can be brought to market. ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Cryopak can assist with the following studies:

  • Needle Sharpness Testing
  • Syringe Testing

Film Testing

There are a multitude of ASTM standards that govern the basic properties and performance of plastic films and sheeting. These standards account for everything from simple, single material films to multi-material, anisotropic constructions and help to characterize such properties as tensile strength, tearing resistance, and puncture energy. Cryopak’s materials engineers have a breadth of experience that ensures accurate, consistent, and timely results that are backed by our ISO 9001 certification and 17025 compliance.

Compression Testing

Materials behave differently in compression than they do in tension. Depending on the specific application, it can be important to perform mechanical tests which simulate these forces the material will experience in actual use. While compression testing is often associated with distribution studies in package testing, it is also used in product testing to evaluate the behavior of finished products. For example, foam can be compressed to determine how well it maintains its cushioning properties.

Fatigue Testing

Fatigue testing is used to determine how many load cycles a material can sustain or the failure load level for a given number of cycles. The results of can vary dramatically depending on the material. Cryopak has several means to conduct fatigue testing including hydraulic and electromechanical. Custom test regimens and test fixtures are available to address varying industry needs.

Flexural Bend Testing

Flexural bend testing method measures the behavior of materials subjected to simple bending loads. Similar to elastic modulus in tensile testing, flexural modulus (stiffness) is the slope as determined by stress over strain in the elastic region of the force vs. deflection curve. It is commonly used on brittle materials such as ceramics, stone, masonry, some metals and glasses. It can also be used to examine the behavior of materials which are intended to bend during their useful life, such as wire insulation, plastic tray materials and other elastomeric products.

Shear Testing

Shear testing is different from tensile and compression testing in that the forces applied are parallel to the upper and lower faces of the object under test. Materials behave differently in shear than in tension or compression, resulting in different values for strength and stiffness. Usually performed on fasteners, such as bolts, machine screws and rivets, shear testing applies a lateral shear force to the specimen until failure results. Lap shear testing is performed to determine the shear strength of an adhesive that is applied to two metal plates and pulled to failure. It can be used to compare between adhesive types or different lots within the same adhesive.

Tear Testing

Tear testing provides information on the energy or force required to propagate a tear through a material. It is commonly performed on foils, plastics, paper, and textiles. Cryopak has capability to perform many different types of tear tests, such as trouser tear, graves tear and the pendulum (Elmendorf) method.

Puncture & Impact Testing

Puncture and impact testing can provide data on how well your product or material can withstand penetration forces. Due to the vast differences in material properties based on rate of energy delivery, there are multiple tests that can be performed to determine these differences. Cryopak has the capability to provide impact speeds of up to 80 meters per minute using hydraulic actuation. We also have multiple shapes and sizes to provide a wide variety of testing capabilities

Coefficient of Friction Testing

Coefficient of friction testing measures the ease with which two surfaces in contact are able to slide past one another where there are two different values associated with the coefficient of friction – static and kinetic. Static friction applies to the force necessary to initialize motion between the two surfaces and kinetic friction is the resistance to sliding once the surfaces are in relative motion.

Tensile Testing

Tensile testing is one of the most common ways of measuring material strength. It involves the linear stretching of a material until failure or some critical value is achieved. Tensile testing can be performed on most types of materials and gives information about yield strength, ultimate tensile strength, modulus of elasticity (stiffness), elongation, and other important properties. It is a reliable way to get data about how different processes may affect the performance of your final product – processes such as sterilization, extended aging periods, and exposure to various temperature and humidity conditions.

Peel Adhesion Testing

Peel adhesion testing gives information about the bond strength created between an adhesive and a substrate. Peel adhesion can also be extended to apply to thermal bonds or other types of mating between materials.

Sutherland Rub Testing

The Sutherland Rub Test helps to determine if printing is durable enough to withstand a typical handling and transportation environment. It is performed by attaching a label to the device while a similar sample label is attached to a weight. The two samples are then rubbed against one another at a controlled speed for a predetermined number of cycles. Once the rubbing stops, the samples are visually inspected to see if the ink has worn off or not.

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