In November of 2013, the Federal government in the United States passed the Drug Quality and Security Act (DQSA) to create a national pharmaceutical serialization and track & trace of which the DSCSA is the part that mandates regulation, mandates serialized coding on primary and secondary pharmaceutical packaging beginning in 2017, and supersedes all state mandates (including California e-pedigree). Global traceability initiatives, such as the DSCSA, are designed to hinder the production and distribution of life-threatening imitation or counterfeit pharmaceuticals. These initiatives can require identification and authenticity features on primary, secondary and tertiary packaging levels typically in the form of unique, non-predictive, serialized and machine readable codes. This level of product identification aims to impair the ability of counterfeiters to successfully replicate pharmaceutical products and packaging.
In addition to public health benefits, serialization provides near real-time opportunity to view and analyze product movement data to capture business value, enhance revenue and increase ROI. Selecting valuable, trusted partners is a primary objective for pharmaceutical companies as they prepare for the challenges that will come with serialization. Put your trust in the experts. Domino brings 37 years of experience for coding compliance.
Domino has extensive experience in developing and manufacturing legislative compliant coding solutions for the pharmaceutical and healthcare sectors. Recognising the challenge to manufacturers in complying with emerging global legislation Domino employs dedicated legal, validation and global standards specialist. Technology meets the demanding requirements of high speed serialisation lines whilst ensuring code quality, high OEE and maximum uptime.
Suggested products?
The following coding and marking technologies are optimal for printing 2D data matrix barcodes in accordance with the requirements of the FDA as well as a variety of other code and text formats for secondary and tertiary requirements.
- Specially developed sector inks ensure excellent dry time, contrast and colour-fastness from manufacture to point of dispensation
- i-Tech components combine to create a flexible, reliable system, including reduced ink wastage and not a single line stop. Caused by unnecessary cartridge changeover
- Capable of high speed serialisation at item level
Laser
- The fastest laser available which will meet virtually all sector coding requirements on labels and cartons
- Easy integration into existing lines or Original Equipment Manufacturer’s (OEM’s) equipment
- Capable of very high speed serialisation at item level
Thermal transfer overlay
- Market leading performance for high speed serialised label and flexible package printing
- Comprehensive software suite for simple integration with existing technology
- i-Tech Ribbon Drive reduces ribbon use by up to 60%
- Premium label and pallet label printing with GS1 coding capability ensuring supply chain compliance
- Vaccuum on functionality to ensure no label (unique number) gets lost when the line is stopped
- Compact design for easy integration into virtually all OEM equipment
- Simple label and ribbon paths ensures quick reliable supply change
Track and Trace is now a reality for the US. Moving from the state e-Pedigree legislation to the federal DQSA mandate all pharmaceutical manufacturers need to comply. Those supplying pharmaceutical product into the state are required to implement product serialization November 2017
Mark Shaffer, Pharmaceutical Business Development Manager Domino North America