Bar Code Considerations
Bar codes are governed by a set of rules called a symbology specification. The FDA has issued its mandate for linear bar codes on unit of use medications, recognizing both EAN.UCC and HIBCC standards and quality requirements. The EAN.UCC system includes a family of advanced GS1 bar code formats specifically designed for unit dose (blister) marking and other applications where space is extremely limited. GS1 will be used on unit dose medication to encode primary product identification. This is a “conventional” linear bar code.
GS1 Stacked also encodes primary product identification but is a more complex symbol. The data is “stacked” in two pieces on top of each other. It is used when the GS1 Limited symbol is too wide. GS1/Composite is even more advanced. It will encode both primary and secondary product information such as lot/batch and expiration date.
GS1/Composite combines a multi-row bar code symbol above an GS1 Limited or GS1 Stacked symbol. HIBCC standards provide MicroPDF417, a “stacked” bar code symbology, for small space marking.
Understanding the data format and structure is a necessary first step.
EAN.UCC Standards
Uniform Code Council
7887 Washington Village Dr., Ste. 300
Dayton, OH 45459
Tel: 800-543-8137 / 937-435-3870
www.uc-council.org
HIBCC Standards
Health Industry Business Communications Council (HIBCC)
2525 E Arizona Biltmore Circle, Suite 127
Phoenix, Arizona 85016
Tel: (01) 602.381.1091
www.hibcc.org
EAN.UCC and HIBCC standards include: data content, structure and format; symbology choice (bar code); check digit calculation; and print quality.
Bar Code Specifications
GS1 DataBar (formerly RSS)
ITS – EAN.UCC Composite Symbology
Bar code symbology specifications are available from:
AIM USA
634 Alpha Dr.
Pittsburgh, PA 15238
Phone: 412-963-8588
Fax: 412-963-8753
www.aimglobal.org
Quality Specifications
Bar code image quality is defined by two different ISO standards, one for the film master and one for the printed image.
Film Master Quality
ISO 15421 Bar Code Film Master Specification
Print Quality
ISO 15416 Print Quality
ISO standards are available from:
The International Organization for Standardization (ISO)
www.iso.org
Equipment Specifications
Image generation software must:
- prevent improper X dimensions
- calculate check character(s)
- accurately generate bar width adjustment
Film master verifier:
- must be designed specifically for film masters
- the Axicon Film Master verifier is the only verifier designed to comply with ISO 15421 for film masters
Printed symbol verifier:
- must perform 10 equally-spaced verification passes
- must calculate ISO 15416 parameters
- the Webscan TruCheck is the only verifier designed to verify stacked bar codes