Plastic is used extensively in modern medicine and the incorporation of plastic into a wide range of medical applications has been increasing steadily over the past decade - but a thermoformed plastic medical device that touches the human body? Is this safe? How is this controlled? How can we ensure that this material meets the proper requirements and approvals for pharmaceutical and medical applications?
After completing the long validation protocols required for medical applications of process and machine, the next challenge is to find the right plastic material that is biocompatible, medical grade, FDA approved and passes all other required rules and regulations. One of the testing protocols commonly used to designate a plastic material safe for use in the manufacturing of medical devices is USP Class testing.
So what is USP class testing? The United States Pharmacopoeia (USP) 30, NF 25, 2007 standard, also known as Class VI, is widely used to comply with stringent FDA regulations for products that come in contact with the human body. The USP outlines classes for plastic materials, i.e. I - VI, with USP Class VI being the strictest, requiring that the material exhibit very low levels of toxicity proven through a series of tests. These USP Standards are set for quality, purity, strength and consistency and published in the US Pharmacopeia and the National Formulary (USP NF).
To achieve USP Class VI certification, the material goes through a series of biological tests: (1) Systemic toxicity, (2) Intracutaneous reactivity, and (3) Muscle implantation. Each testing category includes a full range of tests, procedures and industry best practices for all phases of pharmaceutical and medical device development and manufacturing. A plastic material that has passed class VI certification is expected to be more likely to produce favorable biocompatibility results in order to eliminate the risk of adverse reactions in patients.
It should be noted that while USP Class VI is an important designation for plastics in medical, this certification is not a catch-all for medical applications as far as regulation is concerned: "While USP notes that these tests can be used for medical devices, regulatory agencies of the world generally will not accept a USP certificate in lieu of ISO 10993 testing. USP Class testing is most commonly used to designate a raw material as safe for use in manufacturing medical devices." (Andrew Gottfried, NAMSA) Impact Plastics encourages customers to assess each application on a case-by-case basis to determine if USP Class VI plastic meet the requirements of their application.
With a number of misconceptions in the market regarding the biocompatibility of materials for medical & medical packaging applications, it is important to work with a plastic sheet extrusion partner that offers materials with the proper certifications for your thermoforming project to ensure that you are meeting important safety requirements. Click on the link below to learn more about our certified USP Class VI proprietary formulations: