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.

According 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 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 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.

Unlike manual inspection, machine vision delivers error-free checks on the fastest production lines

Tamper seal inspection on pharmaceutical products

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.

TracePack’s trademarked track-and-trace solution works with networked In-Sight vision systems to create a complete identification and data verification solution for serialised labels on pharmaceutical packaging.

A system that reads and detects label errors is ideal for enhacing product security

DIGITAL AND PHYSICAL ENCRYPTION TECHNOLOGY

When the origin and authenticity of an item cannot be verified, it can become susceptible to counterfeiting. As a result, manufacturers are turning to item-level serialisation to combat the distribution of falsified, mislabeled and potentially hazardous products.

DataMatrix codes allow for detailed information about the manufacturer, product ID, expiration date and a unique serial number to be marked on individual finished goods and packaging. These codes make commonly counterfeited goods traceable and authenticable at multiple stages of handling and the point of sale. By embedding critical product information in codes, companies can take serialisation one step further by using digital and physical encryption.

TracePack helps to isolate the source and extent of safety, quality and counterfeiting control problems with authentication technologies that are compatible through all supply chain stages. UV codes can be added without compromising the aesthetics of highend packaging.

Track-and-trace solutions from TracePack authenticate and verify products along the supply chain. Image-based barcode readers read codes, even ultra-small codes, quickly and accurately to maximise throughput. They can capture and store images of no-reads or string validation failures to fight counterfeiting. For UV codes, barcode readers using a UV lighting module and lens filter illuminate and quickly decipher the code using high-performance decoding algorithms. •

TracePack – www.tracepack.co.za