Regulations Push Vision into Pharmaceuticals

Whether it is 21CFR Part 11 in the U.S., or the International Society of Pharmaceutical Engineering (ISPE)’s fifth edition of Generally Accepted Manufacturing Practices (GAMP): A Risk-Based Approach to Compliant GxP Computerized Systems, government regulations are designed to keep the sick and injured safe on their way to a healthier life.

Pharmaceuticals is one of the most regulated industries – outside of the defense industry – worldwide. To provide the level of required safety, government regulations are specific about how to produce the constituent materials, how to combine them to create a product, and finally, tracking the whole process to verify compliance. This last general requirement is machine vision’s point of entry to the pharmaceutical industry, helping to generate some $60.8 million for vision companies last year, according to AIA’s Marketing Director, Paul Kellett.

End-to-End Production Visibility
According to Randy Kemmerer of the Sensors and Communications business unit of Siemens Energy and Automation (Nashua, New Hampshire), close to 95% of the applications Siemens supports in pharmaceuticals are related to packaging. ‘‘Once in a while we get an application on the process side, but for the most part, it’s all packaging: label inspection and optical character verification.’‘

And when it comes to packaging, pharmaceutical manufacturers pay close attention to serialization, product tracking and record keeping. ‘‘Our main business in pharmaceuticals is identification, quality inspection of products, and product packaging, [including] bottles, blisters, labels, injections and ampoules,’‘ explains Bärbel Weinert, Marketing and Public Relations specialist at VITRONIC Machine Vision Ltd. (Louisville, Kentucky). ‘‘The most common application is reading OCR/OCV variable data on labels.’‘

Traditionally, barcodes are the way to track products through pharmaceutical manufacturing processes. Barcodes are cheap to apply and read, and the technology is mature. However, government regulations are driving manufacturers to push serialization out to both ends of the supply chain, requiring symbologies with greater bandwidth.

‘‘Electronic pedigrees are nothing new, but there’s been much discussion about California’s pedigree laws, in addition to laws around the world, governing the need for serialization in pharmaceuticals,’‘ explains Siemens’ Kemmerer. ‘‘In essence, manufacturers are going to be required to serialize to the smallest saleable level of pharmaceutical product packaging. That essentially means tagging every single product with a human readable number, RFID, data matrix code or all the above.’‘

Despite the fact that machine vision has been supporting data matrix readers for 12 years, the rate of penetration of these devices into pharmaceutical manufacturing continues to grow. The ability to track product becomes even more important in light of a second trend in the pharmaceutical industry to outsource packaging, or separate packaging operations into separate divisions. In either case, pharmaceutical products are temporarily tagged and sent to separate locations for final packaging, aggregation and shipping.

‘‘This is a positive thing for machine vision,’‘ explains David Dechow, founder and president of aptúra Machine Vision Solutions (Lansing, Michigan). ‘‘We’ll be working for a smaller outsourced resource for a big company, and then when the big company takes over, they seem to bring management skills and deep pockets. Larger companies tend to embrace automation technology. They see the return on investment and can afford it.’‘

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Tried & True versus New
Machine vision veterans may look to data matrix readers as commodities, but they’re not the only opportunities available to machine vision in the pharmaceutical industry. Fill levels, web inspection, x-ray contaminate identification and color vision are just a few emerging pharmaceutical applications looking for solutions.

Whatever the solution, pharmaceutical manufacturers are looking for tested, proven and documented reliability in all of their manufacturing equipment, including machine vision. To ease the adoption of their systems by the pharmaceutical industry, VITRONIC focuses on modularity and GAMP validation compliance. Modularity is very important to the pharmaceutical industry because upgrading and component changes can require a complete validation and documentation procedure, versus simply replacing one part with the same part. VITRONIC also ships all pharmaceutical products with a GAMP qualification package that comprises a qualification plan, risk assessment, draft specifications and test specifications for all hardware and software; the company also offers special support and guidance during the on-site installation and qualification of the system – a necessary step for adding any production equipment to a pharmaceutical manufacturing line.

Although the bulk of systems fielded by VITRONIC in the pharmaceutical industry verify and validate codes and labels, the company is also making inroads into contaminate identification via automated x-ray imaging and high-speed line scan of blister packs and other pharmaceutical pages.

‘‘We’re seeing a lot of call for retrofitting older systems,’‘ adds Aptura’s Dechow. ‘‘Pharmaceutical started getting into machine vision about 10 years ago, and now, many companies are looking to get productivity improvements through improvements in automation by adopting newer vision equipment as well as adding new vision systems.’‘

With a long history in the pharmaceutical industry, Siemens meets tough FDA validation standards by only fielding cost-effective, proven hardware, and a 21 CFR Part 11 compliant software platform called Visionscape I-Pak. ‘‘Pharmaceutical packaging has many unique regulatory requirements, unlike most industries served by machine vision,’‘ explains Siemens’ Kemmerer. ‘‘Price points for machine vision components, such as color cameras, line scan cameras, Camera Link® cameras, are all coming down, making these solutions more attractive to pharmaceutical customers and opening up a new range of applications.’‘ Kemmerer points to the advent of smart cameras as an example.

‘‘When smart cameras first came out, they offered a low cost solution to general purpose applications,’‘ continues Kemmerer. ‘‘Regardless of cost, a smart camera without batch level control, or proper documentation for 21CFR Part 11 is not acceptable. We are now running our proven I-Pak interface on our Hawkeye smart camera, making the smart camera relevant to pharmaceutical applications that must comply with FDA regulations.’‘

Although pharmaceutical applications require rigorous testing and often come with higher barriers to entry for new vision companies, knowledgeable vendors and integrators can expect the pharmaceutical industry to demand more and more automated solutions from the vision industry as companies across the board look for robust systems that provide immediate productivity gains.