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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.

Packaging

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.

Packaging

Transport Simulation

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.

Packaging

Environmental Conditioning

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

Introduction to Packaging Validation

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.

Laboratory

Complement Activation

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.

Laboratory

Introduction to Chemical Characterisation

The chemical characterization of materials is an essential aspect of the regulatory review and approval of medical devices in the European Union (EU) and most major markets worldwide. Chemical characterization is also an essential aspect of the overall biocompatibility assessment process, which helps to ensure that the potential benefits of using a given medical device are not outweighed by the potential biological risks associated with that device or its components or materials.

Packaging

What is a Sterile Barrier System?

A Sterile Barrier System (known as SBS) is often present (and mandated by regulation) in the medical packaging industry. It refers to minimum packaging that prevents contamination and helps to sterilize the finished product. The system must guarantee sterility throughout the whole supply chain from production through to the operation room. ISO 11607-1 specifies the requirements related to the compliance of the packaging for sterilised medical devices, including materials, sterile barrier systems and packaging systems.

Laboratory

Introduction to Cytotoxicity

Measuring the potential adverse effects of substances on living organisms is important to multiple industries. A property of the substance that needs to be known is its cytotoxic effect - whilst toxicity is a more general term for how harmful a substance is to living organisms, Cytotoxicity is a term that describes how toxic a substance is to cells.

Medistri SA's Earthwork & Construction Begins

In order to keep up with the growth expectations of our customers, we are pleased to inform that Medistri’s expansion will begin mid-March.