No doubt you have seen my recent posts regarding on-dose identification and our remarkable new Tabrex, the all-in-one solution for digital on-dose printing and inspection #ItsDigital. Time to start sharing some FAQ’s with you!
Q1: Is on-dosage identification a requirement?
A1: Yes, at least by FDA. A portion of FDA 21CFR Part 206.10 states, “No drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product’s size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product.” We’re not aware of similar regulations in other countries as of this writing.
Q2: If I print with ink instead of debossing (with punches), will I save money on press tooling?
A2: Yes, in some instances. It may be possible to eliminate the use of keyed lower punches, which usually cost a bit more than lowers without keyways. Getting away from keyed lowers also eliminates issues with wear on keys and on turret keyway edges. Keyed lowers for round tablets are used when there are bisects and the manufacturer wants the debossing in “registration” front-and-back. With digital printing, the cartridges print simultaneously on front and back with perfect orientation relative to the bisect.
Q3: Can I run my press faster if I use printing instead of debossing?
A3: Not necessarily. With some formulations, issues arise with picking of raised peninsulas and islands (pads) in complex logos and even in simple characters such as A, B, Q, 6, 8 and 9. These issues are often addressed by reducing amount of force used to compress the powder. If lowering force does not produce tablets of adequate hardness, then it may become necessary to extend the dwell time by slowing the press. Digital printing is a great choice since it allows creative use of logos, fine characters and distinctive fonts without impacting manufacturability of the tablets.
We look forward to discussing how Freund-Vector can assist with your on-dose printing needs. Contact Ed Novit, bizdev@freund-Vector.com, for additional information.