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Sterilisation is an important method that manufacturers widely use to keep medical devices safe for patient use. It is a considered a ‘cold’ sterilization technique and offers high compatibility with most materials used in the manufacturing & packaging of medical devices, such as plastics, polymers, metals and glass. For many medical devices, EO sterilisation may be the only method that effectively sterilizes without damaging the device during the sterilisation process.

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 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.

Sterilisation is a crucial process in the pharmaceutical industry to ensure the safety and efficacy of drugs and medical devices. Ethylene oxide (EO) sterilisation is one of the most widely used methods for sterilising pharmaceutical products. In this article, we will discuss the basics of EO sterilisation, its advantages and disadvantages, and its applications in the pharmaceutical industry.

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 (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.

Transport Simulation (also known as Transit Testing) is an essential process that ensures the quality and safety of products during transportation. It involves subjecting products to various tests to simulate the conditions they may encounter during transit. Transit testing is critical for companies that want to reduce the risk of damage, loss, and returns.

Environmental Conditioning simulates particular field conditions that a package will encounter as part of the supply chain. ASTM D4332 is a standard practice for conditioning containers, packages, or packaging components for testing. Specifically, ASTM D4332 is designed for the package to experience simulated environmental conditioning before it is subjected to other testing. So, for example, the ASTM D4332 would be administered as a precursor to the ASTM D4169 test.

Packaging Validation stems from the need to ensure the quality of products across the many steps in your distribution cycle: from shipping to storage. It is indeed an increasingly common requirement for many product categories, including a strong emphasis on the packaging quality requirements for medical and pharmaceutical industries.

The complement system is part of the innate immune system and plays an important role in host defense, inflammation, tissue regeneration and other physiological processes. Complement activation leads to the opsonization of pathogens and their elimination by phagocytes.