Package Material Testing

Material Testing is applied to determine the properties of packaging materials. Tensile testing, torque testing, tear testing, burst testing, bend testing, etc., are the common approach for packaging material testing. Understanding the components properties and how they may change over time or after sterilization, is essential in properly designing effective packaging. The ISO 11607-1 outlines the appropriate approach for distribution simulation, package integrity, and package strength, also states the need to ensure the materials used in a medical device package should comply with physical properties.

We generally take design understanding to a deeper level by testing and evaluating the materials that comprise the package to complement our packaging testing. It's meaningful that materials testing can increase the number of available options for manufacturers to choose.

Material Testing Services for Packing Materials

• Leakage Test

Leakage test is accomplished by filling 10 containers with water, fitting them with intended closures, and keeping them inverted at room temperature for 24 hours. If there are no signs of leakage from any container, this shows the test is passed.

• Collapsibility Test

Collapsibility test is used to remove the contents of squeezed containers. A container by collapsing inward during use, yield at least 90% of its normal contents at the required rate of flow at ambient temperature.

• Clarity of Aqueous Extract
• Water Vapor Permeability Test

Measure the loss in weight of the heat-sealed container filled with nominal volume of water.

• Transparency Test

Detect the cloudiness of the diluted suspension in each container.

Material Testing Services for Glass Containers

• Crushed – Glass Test

Control the particle size and weight of powder to ensure that a constant surface area is exposed to the solution.

• Whole-Container Test
• Chemical Resistant Tests
  • Powdered glass test

    Estimate the amount of alkali leached form the glass powder.

  • Water attack test

    Verify if the alkali leached form the surface of a container is within the specified limits.

• Hydrolytic Resistance Test
• Arsenic Test
• Thermal Shock Test

Examine the outside surface cracks or breakage after transferring sample from hot water to cold water.

• Internal Bursting Pressure Test
• Leakage Test

Material Testing Services for Plastic Containers

• Leakage Test
• Collapsibility Test
• Clarity of Aqueous Extract
• Transparency Test
• Water Vapour Permeability Test
• Non-volatile Residue
• Systemic Injection Test
• Intracutaneous Test
• Eye Irritation Test

Evaluate responses to the instillation of extracts of material under examination in the eye of a rabbit.

Material Testing Services for Closures

• Sterility Test
• Penetrability Test

Check the force required to make a hypodermic needle penetrate easily through the closure. 

• Fragmentation Test

Apply to closure intended to be pierced by a hypodermic needle.

• Self-Sealability Test

Apply to closure intended to be used in multi-dose container.

• Compatibility Test
• PH Test of Aqueous Extract
• Light Absorption Test
• Reducing Substances
• Residue on Evaporation

Determine the residue amount of closure boiled with water for four hours under reflux and the water evaporated to dryness.

With extensive expertise in consulting, package validations encompassing package and sterilization configurations, material qualification, and package development, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have any additional questions about Medical Device Package Material Testing or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

• Sahil Jasuja, et al. "Quality control testing of packaging material."