Electronic records and audit trails are now standard issue as well. Like many competitors, Boekels offers a 21 CFR Part 11 software package. But while it went to great lengths to develop it, Schulze says he has yet to have one customer purchase it. Instead, drug manufacturers are maintaining compliance by printing out and keeping paper records of their particulate monitoring.For some companies, Part 11 software is important, but its also turned into this really cumbersome monster, says Ray Spurgeon, Jr., assistant product manager at Eriez Magnetics (Erie, Pa.), whose E-Z Tec model for the pharmaceutical industry has gotten good play despite not having 21 CFR compliance features. Many of Eriez larger customers are still content with paper documentation, he says.Enter the x-raysAs theyve gotten more robust and reliable, and less expensive, x-rays have infringed upon some of the space traditionally held by metal detectors. While their price tag is significantly higher, they do more, detecting metal, glass, plastic and myriad other contaminants not found by metal detectors, as well as weighing product, assessing density, and inspecting product and packaging for defects or abnormalities. Expect many new product offerings in the next 12 to 18 months, says Wyeth Thomas, Safelines (Tampa, Fla.) sales manager for x-rays.Proponents of x-ray equipment claim that costs will be recouped by a reduction in recalls and dissatisfied customers. The initial outlay is more severe, but the payback is definitely there, says Gary Wilson, president of Loma Systems, Inc. (Carol Stream, Ill.) While 80% of Loma Systems business is for its metal detectors, the company is seeing a 50% increase in interest for its x-ray equipment each year, he says.Uncertainty about radiationUncertainty lingers about whether or how radiation even the low doses given off by todays models might impact the pharmaceutical product. Makers of nutraceuticals and over-the-counter drugs seem to have gotten over this concern, says Jonathan McManus, marketing manager for Mettler Toledos product inspection division. Pharmaceutical clients of Safeline, a Mettler subsidiary, are in the process of convincing themselves of x-rays viability for the inspection of more potent prescription medicines, through exhaustive stability testing and validation, McManus says.Others agree that drug makers are taking a better safe than sorry approach before embracing x-rays on the packaging line. At this point its really more about educating customers, says Wilson of Loma Systems. People are still skittish about the health and product risks.Even with x-rays on the scene, metal detectors will retain a critical niche. Theres always going to be a need off of the tablet press for the type of inspection that metal detectors do, says Spurgeon, Jr. of Eriez.X-rays and metal detectors can complement each other in processing and packaging operations, says Oscar Jeter, national sales manager for Safeline. Integration of technologies, including checkweighers and vision sensors, allows drug manufacturers to know their product as intimately as possible.
A SAMPLING Metal detection and x-ray equipment makers continue to roll out models with greater sensitivities and more bells and whistles. Here are just a few: |
Boekels Observer (at right)The Sartorius-bred magnetic detector, due in the U.S. late this year, purports to pick up metal contaminants even in foil-packaged products.Bunting Magnetics Co.s PharmatronThe Pharmatron boasts a 1 MHz frequency and adjustable sensitivities, as well as a Quick Disconnect reject option and the ability to be cleaned without tools or dismantling.Ceia THS/PH21Italys Ceia is seeking to make inroads into the U.S. pharmaceutical market. The THS/PH21 model for tablet and capsule inspection meets 21 CFR Part 11 standards.Eriez E-Z TecThe E-Z Tec DSP (Digital Signal Processing) model allows for detailed analysis and reporting via a small touchscreen interface, in multiple languages if necessary. Eriez is the only metal detection company making its equipment in the U.S., assistant product manager Ray Spurgeon, Jr. says.