PACKAGING: SERIALISE, TRACK & TRACE
Vision systems for a safer supply chain With the use of machine vision technology, manufacturers, regulators and consumers can ensure that counterfeit pharmaceutical products and medical devices are identified and removed from the supply chain before they cause any harm. TracePack offers customised, innovative solutions for every application.
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ccording to the World Health Organization, 5% to 10% of global pharmaceuticals are counterfeit. The number of counterfeit medicines is also increasing by 6% to 8% per year. To fight this problem, regulators around the world are in the process of establishing stricter regulations for pharma manufacturers, co-manufacturers and packers, distributors and retailers to prevent counterfeit drugs from making their way into the hands of consumers. Unfortunately, this effort creates
Barcode inspection technology from TracePack verifies the quality of required elements on packaging, such as logos and date/lot information
significant challenges for drug manufacturers, which require inspection and identification solutions for new products.
AUTOMATED VISION SYSTEMS Life science, biotech, pharmaceutical and medical device manufacturers face regulatory requirements that affect the compliance of their vision and labelling systems. These include FDA 21 CFR Part 11, digital records submitted electronically for regulated FDA filings and Unique Device Identifier (UDI) requirements for device labels and packages. Similar versions of these regulations apply in the US and the EU. TracePack’s vision systems support 21 CFR Part 11-compliance and integrated label management across supply chains required by UDI. Production and distribution of only perfectly identified products at plant level can be achieved with the help of vision systems, allowing counterfeits to be more easily removed. These systems also help validate
Tamper seal inspection on pharmaceutical products
"Unlike manual inspection, machine vision delivers error-free checks on the fastest production lines" the presence, accuracy and readability of various pharma products to safeguard package integrity in all areas of the supply chain. Unlike manual inspection, machine vision delivers error-free checks on the fastest production lines. This ensures that complying with regulations and standards does not impact production levels or cause bottlenecks in the supply chain.
ANTI-COUNTERFEITING PROTECTION A major business driver of pharma and bio-science product manufacturers is the need to cost-effectively comply with patient safety and traceability requirements. Whether inspecting package integrity, tracking serialised products from manufacture to a patient, or checking label accuracy with barcode and text verification, TracePack’s deep learning, vision and barcode-reading solutions add value every step of the way to improve quality, prevent defects, increase yield, boost productivity and achieve compliance. In this regard, overall equipment effectiveness (OEE) improvements are increasingly important. Cognex vision and ID products help with three traditional OEE drivers: • material handling efficiency and flexibility • product quality and yield • package safety and integrity.
BRAND PROTECTION AND COMPLIANCE As compliance with global traceability requirements and transition from batch to item-level serialisation are prepared for, it is important to remember that compliance requires much more than simply reading a code on a label or part. For mass serialisation to support traceability, it is essential to first verify code quality and validate that all the encoded data is accurate and correctly formatted.
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SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA
