Track and trace
The blow-fill-seal process aseptically fills and seals the container while it's still in the mold. Molds frequently are designed
to produce two or more containers simultaneously. (IMAGE COURTESY OF ROMMELAG)
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A track-and-trace system conveys, uniquely marks, and verifies 450 pharmaceutical packages per minute so that individual packages
can be tracked through each phase of the packaging line and throughout the distribution system. Positioned immediately downstream
of a cartoner, the system conveys each carton past a noncontact laser or thermal inkjet printhead that applies a two-dimensional
barcode, batch number, lot number, production date, expiration date, and other desired information, as well as a unique number
for mass serialization. The unique, random identifier, known only to the pharmaceutical producer, prevents counterfeiting
and facilitates accurate traceability.
Using high-resolution vision technology, the system inspects and verifies printed data and label alignment and records information
in an internal database. An air knife blows non-readable cartons into a secure reject bin equipped with a sensor to confirm
that a reject has been accepted. A quick-change mechanism expedites adjustments for various carton sizes. Windows-based operation
is controlled at the swing-arm-mounted, 17-in. (432-mm) touch screen. Line-management software manages individual or multiple
vision sensors, coding devices, checkweighers, and associated equipment across automated production and packaging lines (Line
Director Production Line Management Software, Crest Solutions).
End-ported biocontainers like this one from Meissner Filtration Products meet the growing demand for single-use systems. (PHOTO
IS COURTESY OF MEISSNER FILTRATION PRODUCTS)
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The track-and-trace system also uses database-management software to simplify implementation of product traceability (Protrack
real-time database management software, Crest Solutions). Employed as a stand-alone system or as a component of an integrated
line, the coding and data-collection system enables paperless compliance with existing and upcoming national and international
track-and-trace regulations, including Brazil ANVISA, TS (Turkey), French Coding, California ePedigree, Good Automated Manufacturing
Practice 5, and 21 CFR Part 11 (PharmaMarker 450, Eisai Machinery USA).
Barrier material
A foil lamination with a frangible sealant layer keeps product components isolated from each other until they reach the point
of use. Breaking the seal permits the contents of each compartment to mix or dispense together. Two distinct heat-seal profiles
allow the sealant to produce a permanent seal and a frangible seal. Applications include skin applicators and dual-component
products (PerfecPharm P702, Perfecseal).
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