As the pharmaceutical industry prepares for the FDA’s new DSCSA compliance rules this November, and as companies look to boost manufacturing productivity, quality and safety, machine vision technology is playing a crucial role.
Machine vision sensors, which automatically scan barcodes and capture and analyze images of products and packaging, are helping pharmaceutical businesses not only track and trace all their products, cartons, and pallets but also maintain digital records of their physical movement, as required by the new DSCSA standards. Companies are also taking the opportunity to use these same technologies to automate more of their production and packaging processes, and to inspect each product and package automatically and visually for quality assurance.
In this article, we’ll take a look at some of the latest machine vision sensors and software from Zebra. We’ll explore how they’re used to meet pharmaceutical compliance and traceability requirements as well as to automate production and quality processes, and we’ll look at how Zebra’s innovative approach to machine vision makes it far easier and more affordable to add or expand industrial automation in your pharmaceutical operations.
Let’s start by exploring how Zebra machine vision sensors are being used to meet the upcoming DSCSA final rules from the FDA.
Meeting DSCSA Requirements with Machine Vision Automation
Zebra machine vision sensors are small, compact yet rugged devices that have two crucial capabilities, and the first is that they’re able to automatically scan and inspect GS1 barcodes, including 1D and 2D barcodes.
This allows pharmaceutical manufacturers and distributors to install machine vision sensors on production and conveyor lines or anywhere that products are moving through processes, and the sensors can scan barcodes on moving products or packages, to capture and analyze every barcode at extremely high speeds.
As barcodes are captured, they’re used to instantly identify each product or label, and they can be used to verify a product’s authenticity, to ensure correct labeling and packaging, and to document its status and location for DSCSA compliance purposes.
This is crucial because the DSCSA final rules include the Electronic Product Code Information Services (EPICS) rule, which requires that each pharmaceutical must be serialized according to the GS1 barcode standard. This allows pharma companies and others in the supply chain to identify and track which serialized product is in which carton and which carton is in each case and on every pallet. Each product’s physical movement must also be tracked, and all resulting aggregation data must accompany each shipment between trading partners.
Zebra machine vision sensors and software are able to capture and transmit all the required serialization and unique identification information to your industrial and other business systems. They can also work together with your systems to log time stamps and locations for each product or package.
This means you can automatically trace products, packages, cartons, cases and pallets that are moving through your manufacturing, packaging and distribution operations, and you can maintain a digital record of every event and location for DSCSA compliance.
Pharmacies can also use machine vision sensors to achieve real-time visibility into prescription stock, reduce manual data entry requirements and collect accurate dose-level data for all products. This data can help pharmacies decommission expired or damaged stock.
Using Machine Vision to Automate Production Processes and Visual Inspections
Zebra machine vision sensors are also able to capture up to 16 images of a product, label or package in a single event, each with its own settings and automated analysis.
This means you can use them to capture and analyze images of products to inspect for size, shape, color, uniformity, and potential contaminants and defects. You can also instantly detect issues with packages, dates, lot codes, labels, seals and caps.
You can also set up automated visual inspections of labels and packaging to ensure the right products are going into the right packages with the right label and information, right down to recognizing specific strings of text characters with optical character recognition (OCR).
Additionally, Zebra’s sensors are able to help you automatically count, route and sort products moving through your production processes. The sensors can identify them visually and instantly transmit corresponding information to your industrial automation or robotic systems, so products of one type can be automatically routed to the correct diverter line to go into specific packaging. Products of other types can also be recognized automatically and routed accordingly.
Machine vision can also be used to visually inspect products and packaging to ensure the right items are included in blister packs or cartons, and to check whether the right inserts are included in a box or carton.
An Easier and More Affordable Approach to Industrial Automation
Ultimately, the potential applications of Zebra machine vision technology are virtually limitless. But perhaps the best aspect of Zebra machine vision sensors and software is that they’re a huge leap forward simplicity, accessibility and affordability.
In the past, setting up machine vision sensors or smart cameras meant using different hardware and software, often from different providers, for different types of jobs. Sensors were often not very easy to use, and the software was typically much worse, with outdated and clunky interfaces that made everything more time-consuming and difficult.
This is why Zebra introduced its own platform for industrial automation. After decades of working with global customers to provide data capture and mobile computing solutions such as barcode scanners, RFID technologies, and handheld computers, Zebra heard many complaints about industrial automation technologies and set out to enter the space and deliver the kinds of solutions customers desperately needed.
The end result was the introduction of a singular platform for both machine vision and fixed industrial scanning, with plug-and-play sensors and one software application to set up and configure every job.
Instead of buying different hardware and software and having to learn and deal with it all, Zebra provides a single set of sensors and a single software application that have been designed from the ground up to be so easy to use that beginners can get up and running in no time. But the automated image capture and analysis tools are extremely sophisticated, with the ability to use lighting, lensing, filters, object location, pattern recognition, edge detection, and even pixel counts and blob analysis to conduct extremely precise inspections with machine accuracy.
Using some sliders, radio buttons and simple drop-down menus in Zebra’s Aurora Focus software, plus Zebra’s AutoTune tool, users can set up sophisticated machine vision image capture and analysis in as little as a few minutes.
Devices can be connected to industrial networks and systems via TCP/IP, Serial, Profinet/Modbus, or CC Link protocols, and they can be connected to a monitor, other devices and systems via USB-C, dual Ethernet and hardwired GPIO inputs/outputs. There are also flexible power options, with the choice of USB-C, 24V or Power over the Ethernet (PoE).
Once your sensors and jobs are configured, they handle all your scanning and inspections automatically, with simple pass/fail or other analysis results sent to your systems and automated exception alerts in the event of an issue. You also have the option to securely save images and results to the cloud for sharing, analysis and post-processing. And you can output your scanning or visual inspection results to a monitor if desired, with no need for a separate PC for output.
Best of all, Zebra’s innovative approach to machine vision saves up to thousands of dollars in costs, by reducing the amount of hardware and software you need to buy and eliminating the need for computers or workstations as part of your system.