The United States Pharmacopoeia, or USP, is a long-running publication that covers and describes a wide variety of standards and best practices. The twenty-second edition of this reference, usually referred to as USP XXII, contains the latest requirements concerning hundreds of processes and materials commonly used in the medical and pharmaceutical industries.
USP XXII Compliance is Often Difficult but Always Significant
Complying with the relevant USP XXII standards is an important duty for businesses and groups of many kinds. Failing to do so can mean engendering public health hazards and exposing a group to regulatory fines or legal judgments. Fortunately, vendors that produce and market materials and finished products that comply with USP XXII always have compelling incentives to keep their own related standards high.
One commonly employed coating known as parylene, for example, is available from a number of sources whose own processes and production methods have been designed to ensure strict compliance with USP XXII at all times. A look at what this means in practice will reveal there are many ways USP XXII ensures important forms of protection and suitability for even the most critical of applications.
Many Ways a Material Can Be Tested Against USP XXII
Advanced coatings are used in many ways in healthcare today, and even a slight mismatch with the applicable requirements can be harmful. Some of the ways a coating might need to live up to standards found in USP XXII relate to characteristics such as:
Toxicity. A coating that can provoke a toxic reaction in human beings could end up doing harm in a situation where it was meant to help. A USP XXII Class VI biocompatibility rating that designates a particular material as nontoxic will allow it to be employed in applications where others could not be used.
Reactivity. Some coatings are more or less chemically inert and can be used in environments where normally reactive substances might be found. Materials and coatings that pass the reactivity tests described in USP XII can be relied on in such settings with confidence.
Issues like these are often of great importance in the healthcare and medical product industries. Suppliers whose materials comply with specific, relevant USP XXII standards enable other companies to achieve results that might otherwise be out of reach.
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