Plastics Testing
Plastic has many unique properties in terms of its manufacturability and production potential. These properties are increasingly used in the manufacturing of medical devices and medical packaging. Despite the significant growth, the safety requirements do not change.
Medistri provides phthalate trace level detection analysis and screening of polymers and other materials.
Phthalates are a category of chemical compounds that are used in a wide range of industries. Typically, they are used as a form of additive in plastics: they allow for the improvement of durability, flexibility and transparency.
Due to their regular usage in everyday products, there are concerns about the potential harmful effects of phthalates on human health. Some of them are classified as carcinogenic and/or mutagenic and/or toxic.
Some industries have put in place multiple frameworks to regulate the types and the levels of phthalates in wide range of products.
Medistri can perform phthalate trace level detection analysis and screening of products and materials especially made of polyvinyl chlroride (PVC).
These regulations require some industries to heavily & regularly monitor the presence an amount of these specific compounds. They have been established to monitor either low percentage or part per million (ppm) levels.
As a high degree of sensitivity and expertise is required, Medistri conduct this analysis using Gas chromatography/mass spectrometry (GC/MS) detection.
CLASS PLASTICS TESTING – USP <88>
USP <88> Class Plastic Tests are designed to assess the biological reactivity of various types of plastics materials in vivo. Originally developed to test drug containers, the USP class plastics tests are often performed on unmolded plastic resins as well as containers. Class plastics testing is not a substitute for testing performed according to ISO standards, but is often used by manufacturers to classify/certify materials. The USP defines six plastics classes, from class I to class VI with class VI being the most rigorous and most frequently requested certification.
Many plastics manufacturers find it advantageous to have their materials classified, especially if their plastic resins are a likely candidate to be used in medical devices. A plastic material that has passed the USP Class Plastics tests are expected to be more likely to produce favorable biocompatibility results.
Our Laboratory
Medistri's contract Laboratory is located in the heart of Switzerland to continuously serve the countries most innovative universities, research institutes, start-up companies & large enterprises from the Pharmaceutical, MedTech & BioTech industries.
Packaging
The validation of packaging 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.
Our Quality Certificates
Explore our list quality certificates and discover why the world's most innovative healthcare companies choose to work with Medistri.
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