Quint Company has been a pioneer of pharmaceutical bar code blister packaging for 30 years.
Why we care about our barcode blister packaging quality:
Bar codes save lives. AMA studies report that 20% of prescribed medications taken by, or administered to, patients were of the wrong dosage. An estimated seven thousand deaths every year are attributed to medication dispensing errors. Nearly 90% of these could have been prevented by the use of bar codes on unit doses at the time of administration.
The FDA has recognized the demonstrated benefits of bar codes and has mandated bar codes on all over-the-counter and prescription medications in hospitals, including unit doses. While there is no cure for illegible handwriting on handwritten prescriptions, bar codes eliminate human error in dispensing and verifying medications. A simple scan of the bar code can confirm the correct medication and dosage. When used with bedside scanning of patient wristbands, unit dose bar codes also help ensure that the right patient is getting the right medication in the right dosage at the right time. Bar codes also help keep health care costs down by providing a quick and accurate way to track and control pharmaceutical inventories. It all begins with the bar code. And the bar code begins with the platemaking process.
The GS1 bar codes used on unit doses have been designed specifically for use in limited spaces. They have been rigorously tested to ensure accuracy and printability. Understanding the data format and structure is a necessary first step.
Total Bar Code Quality
With so much depending on the printed bar code on unit doses, quality is a critical issue. An out-of-spec bar code may be an unreadable bar code. And a bar code with improperly formatted data may be worse than no bar code at all! Yet many companies invest significant amounts of money in implementing bar code labeling – and do it wrong.
What Is It?
Total bar code quality is more than just printing a series of bars within tolerance. A healthcare-compliant bar code is constructed according to specific rules that govern:
- data content/structure,
- data format,
- symbology (bar code),
- check digit calculation, and
- print quality.
Print quality comes last on this list because, if any of the other five items are not in complete compliance with healthcare guidelines, print quality means nothing. Total bar code quality begins when an order is placed with a platemaker. The platemaker must first ensure that the requested bar code and supplied data conform to the appropriate rules. Before proceeding, the platemaker must first perform the appropriate:
- encodation check,
- format check, and
- symbology check.
Once these are completed, bar width adjustment must be calculated. Each ink and substrate combination produce different results. In some cases, ink bleeds into the substrate; in other cases, it beads on the surface of the substrate. These differences may be minor or significant. The platemaker must understand these differences and provide test targets to be run on a specific press using a specific anolox roller, ink and substrate combination. Printed test images can then be used to calibrate the image creation and platemaking process. The bar code imaging system must be calibrated each day and for each new batch of material. Only when the system calibration is completed should the platemaker proceed.
The platemaker must ensure that the bar code image in every step of the process will result in a plate that will produce a high quality printed bar code.
Why Do You Need it?
Printing bar codes is very different from printing human readable text. Small variations in ink coverage do not significantly affect human-readable text but they can make a bar code unreadable. Most pharmaceutical packaging lines are quite skilled in producing good quality human-readable text. Very few are experts in producing good quality bar codes. Unreadable bar codes waste healthcare workers’ time and, in certain critical care situations, may hinder the efforts of health care professionals. Even a perfectly printed symbol may be of no use to the health care provider if it has the wrong data or format. At worst, an incorrect bar code may corrupt the medication database and patient record. With lives at stake, there is no substitute for total bar code quality.
Printing GS1 bar codes on unit dose packaging requires a platemaker with knowledge of the symbologies and standards as well as a total commitment to quality.
How Do You Get It?
Total bar code quality begins with you, with your information systems, purchasing, printing and packaging/graphics departments.
Information systems must be able to provide correct product identification to the platemaker for each medication and each level of medication packaging.
Purchasing must recognize the need to use a knowledgeable platemaker, not the lowest bidder.
Printing operations must work with the platemaker to determine the print parameters for every press, ink, substrate, and bar code. The proper ink and substrate must then be used for every run.
Packaging/graphics must inform the purchasing department or platemaker if there are any planned changes in press, ink or substrate.
There must also be a single, knowledgeable contact person within your company who can answer any question about the order that the platemaker may have. The platemaker’s responsibilities are no less demanding. The platemaker should operate under cGMP-like guidelines. This is your assurance that the platemaker’s processes and procedures comply with the highest standards. The platemaker should have process control and documentation procedures in place for every step of the operation from order entry to delivery. Data and bar code image should be validated and verified at every step and proof of this validation should be provided with the finished plate.
There are four errors that are the most common in generating bar codes:
- wrong data/format encoded
- incorrect check digit
- incorrect bar width adjustment
The first two problems occur when customer-supplied data does not conform with guidelines. Data and format checks by the platemaker must identify these errors. The last two problems results from improper compensation for the output device or for the expected bar growth or shrinkage during printing. Quality assurance before and during image creation and platemaking, and verification of the symbol, must be in place to prevent this.