Go To All Pad Printing Inks

Printcolor proudly announces that several of their 700 Series pad printing inks are now USP Class VI tested and approved.  This includes our new UV pad printing ink Series 747 and 711 and 752 inks (our two most popular pad printing inks for the Medical device industry).  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.

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 “elastomerics, plastics and other polymeric material 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. Class VI requires the most stringent testing of the 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.

Systemic Injection Test and the Intracutaneous Test. Materials that pass these two tests are compliant with USP Class VI. USP Class VI includes the tests of USP Class VI plus 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.