So, you want to contract out packaging for your companys new drug or dosage form? Sure, there are several good contract firms to choose from, but even the best vendor is not telepathic. Pharmaceutical Manufacturing spoke with Chuck Ravetto, director of product management for Wood Dale, Ill.-based Videojet Technologies Inc. to clarify what manufacturers need to know before they pick up the telephone.
One key consideration is achieving a harmonious relationship between the substrate and the printer. All pharmaceutical packaging involves coding and marking, at least at the case level and, especially with over-the-counter drugs, at the item level as well, Ravetto observes. The manufacturer has to be sensitive to the substrate; they must know precisely what type of material is being coded matte paper, glossy paper, glass, plastics such as HDPE (high-density polyethylene) or PET (polyethylene terephthalate), etc. in order to determine whether the contract packager should use inkjet or laser printing.
Many pharmaceutical contract packagers have both inkjet and laser printers in-house so they can accept work requiring either type of coding, Ravetto says. What changes most for a contract packager, depending on the volumes and due dates of various contracts, is the labor demand (both the number of employees and the number of shifts).
The substrate is a key factor, but not the only one to consider in determining which type of printing is appropriate for a particular job. Ravetto notes that laser printers can achieve higher-resolution print than inkjets. With laser printing, the code height and width and the number of lines of print determine the power and size of the laser the packager will need to use.
On the other hand, inkjet printers offer greater flexibility, says Ravetto. A wide range of inks is available, including multi-purpose inks that can print on paper, plastic, glass and metal substrates. He explains, You can find an ink that will stick to anything, whereas lasers dont work well on HDPE, metallic substances such as foil blister-packs, or white surfaces (see photos below). Laser printers are best for paper-based or colored surfaces.
Complicating the printer-substrate relationship are special applications or demands placed on the printed surface. For example, Ravetto notes that a drug manufacturer may require that the code be resistant to an alcohol rub, to water, to salt, or finger rub tests or to an ice bath, and that will impact the chemistry of the ink that is used. Or, if a more advanced barcode such as a two-dimensional RSS composite is called for, laser printing should be used to obtain the best result.
Another element that should be part of any negotiation with a contract packaging firm is validationspecifically, how does the packager validate that the code is on each package, in the right location, and that it is the right code? Questions should include: Do they use a machine vision system? Does their validation process meet 21 CFR Part 11 requirements? What sort of documentation do they provide?
A pharmaceutical manufacturer must also determine its track and trace requirements for each specific job and communicate those to its contract packager. Although it is now possible to code products down to the individual dose level (thanks to edible inks and a proprietary tablet-coating-plus-laser-coding process available from DataLase), few manufacturers are using technologies such as RFID below the case level, according to Ravetto. One covert technology that can be employed cost-effectively at the unit level is a special ink that is only readable under ultraviolet (UV) light. The UV-sensitive ink can be used in many standard inkjet printers.
Track and trace technologies have experienced rapid growth in recent years and will continue to evolve due to ever-escalating concerns about drug security and a desire among drug makers to improve monitoring and control of their supply chains. Lest manufacturers think they can replace one technology with another, Ravetto observes that, The one thing that hasnt changed is the amount of coding thats human-readable.