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

Quint Company equipment and processes conform to all these requirements.