Yikes – despite the FDA issuing a one-year delay in DSCSA product identifier enforcement last June, much of the pharmaceutical industry is struggling to be ready in time. In a survey conducted by the IQPC last spring, approximately one quarter of respondents said their companies wouldn’t be compliant for 18 to 24 months, which is after the serialization deadlines for both the FDA and the European Medicines Agency (EMA).
To help make it easy and affordable for pharmaceutical manufacturers and contract packers to comply with traceability requirements, NJM Packaging and OPTEL have teamed up to offer track & trace solutions. Together, we’ve integrated our Trotter W pressure sensitive labeler with OPTEL’s BottleTracker™ to achieve in-line serialization and facilitate accurate aggregation at secondary packaging on automated lines.
First, a thermal transfer printer or laser printer mounted on the Trotter W adds variable data, including serialized information, to the labels. Next, the Trotter W applies the wrap-around labels on round containers at speeds up to 150 bottles per minute. Then, the BottleTracker prints a ‘unique identifier’ in black or invisible UV ink on the bottom of each bottle and associates each unique identifier to a serialized code.
This approach facilitates aggregation by enabling a vision system at secondary packaging to capture one image of the entire group of bottles, with the unique identifier of each bottle in that group visible. Compared to traditional solutions that track each bottle going into a bundler or case packer, this NJM/OPTEL system reduces errors to improve serialization compliance and manufacturing efficiency.
For customers requiring higher speeds and/or the ability to label other bottle shapes, we offer additional labelers for integration with OPTEL’s BottleTracker.
Visit our website to watch a video of an integrated serialized bottling line.