Pad Printing Inks that are USP Class VI Tested and Certified for Medical Device Pad Printing on Various Substrates

The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneously Toxicity tests which allow these three inks to be certified for the use in printing on various plastic materials used in manufacturing of Medical Devices.

The United States Pharmacopeia (USP) is a private (non-governmental) organization that "promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies." Those standards include in vivo animal biological reactivity tests for "elastomeric, plastic and other polymeric materials with direct or indirect patient contact." USP monograph (88) describes the classification of plastics into six classes based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. USP Class VI requires the most stringent testing of these six classes. Extracts of the test material are prepared in saline, alcohol in saline, polyethylene glycol (PEG 400), and vegetable oil. The extracts (diluted in the case of the PEG extract) and blanks are injected into mice and rabbits, which are observed several times over a 72-hour period. The animals' response to the sample extracts and the blank are compared to determine test passage.

The systemic Injection test and a Intracutaneous-test are the first two testing methods used to determine which products (inks in this case) are deemed compliant with the USP Class VI. Furthermore, USP Class VI includes an implantation test wherein strips of the test material and a negative control are implanted in rabbits for a period of not less than 120 hours. Hemorrhage, necrosis, discolorations, and infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.

Technical data sheets, SDS sheets and Class VI certifications are hyperlinked on this page (bottom right side next to each of the available products). infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.

711-8005 BLACK pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

711-9005 WHITE pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

747-8005 BLACK UV cured pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

747-9005 WHITE UV cured pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

752-8005 BLACK pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

752-9005 WHITE pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

Printcolor and Deco Tech have long been leaders in providing USP Class VI certified inks for printing on plastic medical devices. Among these are Printcolor’s UV-cured pad printing ink Series 747 and the popular Series 711 and 752 inks, which have been rigorously tested and approved for safe use in medical device manufacturing. These certifications assure compliance with the strictest safety and biocompatibility standards, making them ideal for critical medical applications.

USP Class VI certification involves comprehensive biological reactivity testing, ensuring that the inks are safe for use on materials with direct or indirect patient contact. The United States Pharmacopeia (USP) establishes these standards to promote public health by setting benchmarks for medicines and healthcare materials. The certification process includes systemic injection and intracutaneous toxicity tests, evaluating the inks’ compatibility with human tissue and systemic safety.

In the testing process, extracts of the materials are prepared using saline, alcohol in saline, polyethylene glycol (PEG 400), and vegetable oil. These extracts, along with control samples, are injected into laboratory animals, and their biological responses are monitored over a 72-hour period. Additionally, an implantation test is conducted, where strips of the material are implanted in rabbits for 120 hours. Observations for hemorrhage, necrosis, discoloration, infection, and encapsulation ensure that the material meets the stringent standards of USP Class VI.

This rigorous process ensures that Printcolor’s Series 747, 711, and 752 inks are not only safe but also reliable for use in producing high-quality medical devices. These inks are trusted for printing on items such as syringe markings, medical equipment housings, and other critical components. For additional details, technical data sheets, safety documentation, and Class VI certifications are available for review, ensuring full transparency and compliance.