Seal Tensile Strength
Making sure that the sterilization is done correctly is one of the main priorities in the medical device and packaging industry. All medical packaging, whether it is a single-use product or intended for resterilization and reuse, must be strong enough to be easily opened by healthcare providers while ensuring product sterility. To ensure that packaging achieves this delicate balance, many manufacturers follow test standards such as ASTM F88 to measure the tensile strength of adhesives used in medical device packaging.
Dye Migration Tests
Medical device manufacturers need to ensure the integrity of packaging seals. One of the key methods employed to verify seal integrity is the Dye Migration Test. This test, governed by standards such as ASTM F1929 and F3039, utilizes a brightly colored dye to visually detect any channels or leaks in the package seal. The process involves filling the package with a dye solution, subjecting it to conditions that might cause the dye to migrate through potential leaks, and then inspecting the package for any evidence of seal failure. The Dye Migration Test is an essential part of quality control processes, helping manufacturers ensure that their packaging is secure and reliable, thereby maintaining the sterility of the medical device until use.
Compression Test
Compression tests are used to determine a material’s behavior under applied crushing loads, and are typically conducted by applying compressive pressure to a test specimen (usually of either a cuboid or cylindrical geometry) using platens or specialized fixtures on a universal testing machine.
Introduction to Concentrated Impact Test
Concentrated Impact Test is a type of transit testing that is performed to make sure a package can withstand the rigors and environment of the distribution cycle. It is one of the most widespread impact testing methods for measuring the protective capacity of packaging.
Mechanical Handling Test
Mechanical handling refers to the use of machines and equipment to move, store, control, and protect materials, goods, and products throughout the process of manufacturing, distribution, consumption, and disposal. Mechanical handling tests are used to evaluate the ability of shipping units to withstand the stresses of manual and mechanical handling during the distribution process.
ASTM Packaging Standards
ASTM is one of the world's leading international quality organisations. The ASTM guidelines are an agreement between consumers, manufacturers, government agencies and scientists from over 140 countries on the implementation of packaging quality and testing requirements.
Visual Inspection Testing
Visual Inspection Testing provides a qualitative visual inspection to evaluate the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package. ASTM F1886 covers the determination of channels in the package seal down to a width of 75 μm (0.003 in.) with a 60 – 100 % probability.
Real-Time Ageing Tests
Real-Time Ageing Tests are a great way to test the durability of a product. They can also be used to test how quickly an object will deteriorate, or even how long it takes for certain chemicals to break down. It's important that you follow all safety precautions when performing a real-time ageing test.
Accelerated Ageing Tests
Accelerated ageing tests are essential in determining the expected lifespan of materials and products in a shorter period of time. These tests are conducted to simulate the natural ageing process under extreme conditions, such as high temperature and humidity, to predict the performance and durability of the materials and products.
Integrity Testing
Integrity testing (also known as Sterile Barrier Integrity Testing) is a critical quality control measure used to ensure the integrity, or the ability of a package to contain and protect its contents. Integrity testing is used to detect any leaks, punctures, or other defects that can compromise the packaging and potentially lead to contamination or spoilage of the contents.