Welcome back to the NCA Ltd blog where we offer the latest insights, updates and developments at NCA Ltd. This week, we are delighted to announce that our material NORLITE has been certified for USP 87 and USP 88 (Class VI). Our Acrylic (PMMA) has now been re-approved for medical device application and supports the market interest in our manufacturing capability.
What is USP Class VI Testing?
USP Class testing is one of the most common methods of testing to determine bio-compatibility of materials. There are six classes, VI being the most rigorous. Class VI testing is aimed to certify that there are no harmful reactions or long-term bodily effects caused by chemicals that leach out of plastic materials. USP Class testing is frequently conducted on plastic materials that are used in the pharmaceutical and food industries.
USP Class VI Testing Methods
USP Class VI testing is conducted by producing an extract of the product with different extraction fluids, such as polyethylene glycol and vegetable oil, and injecting it in specimen (rabbits and mice) in vivo (alive), to observe the biological response to the extract. Testing is commonly done as per USP <88>, which requires three types of testing: systemic injection, intracutaneous, and implantation.
Systemic Injection Test (Acute Systemic Toxicity): Test specimen are injected with the extract intravenously and observed for 72 hours. The specimen are monitored for any abnormal toxic reactivity. The scientist determines the test as pass/fail.
Intracutaneous Test: The purpose of this test is to check for any local skin reactions. Test Specimen are injected with the extract intracutaneously and observed for 72 hours. The reactions are scored and averaged.
Implantation Test: Specimens are implanted with the product material to observe the reaction of the live tissue in direct contact with the product over a span of at least 120 hours (5 days).
Why should products be USP Class VI?
Class VI testing extensively investigates the reaction in the body, skin, and living tissue to ensure safety. USP Class VI is a common standard for pharmaceutical and food industry tubing, fittings, single-use systems, and fabricated parts. Reaching this standards demonstrates NCA Ltd’s commitment to the fabrication of the highest standards and integrity.