More than ever, drug makers cannot afford to allow the errant piece of wire or fleck of metal to enter product, or packaging, headed to the consumer. Traditional magnets and advanced electromagnetic devices used for detecting metallic particles have been joined of late by x-rays, with emerging technologies (MRI and ultrasound, for example) on the horizon.
For now, single- or multiple-coil electromagnetic detectors predominate. Though detector technology is mature, sensitivities have improved, with most detectors down to the .25 to .50 mm range for picking up stainless steel particulates in prepackaging operations.
Metal detectors have had limited use on packaged materials involving metallized films or foils, such as those on blister pack backing, which interfere with detection signals. Sartorius, which markets in the U.S. under the Boekels name, claims to have foiled the foil with its Observer detector, which ignores aluminum yet detects iron or stainless steel contaminants. It’s a magnetic (rather than electromagnetic) detector which “premagnetizes” product at infeed. “Work-hardened” stainless steel (such as chips or flakes) holds a brief magnetic charge, allowing it (and ferrous materials) to be detected within the product’s aperture, says Mark Schulze, managing director of Boekels distributor International Automation, Inc. (Oakland, N.J.).
The product is in use at 15 German sites, Schulze says, and will be available in the U.S. late this year.Full service is standard
Pharmaceutical manufacturers in the market for metal detectors are likely to see the greatest changes in automated features and enhanced support services offered. Thermo Electron, for example, has introduced AuditChek, a standard feature on its Goring Kerr DSP Rx models. The equipment itself, rather than a human operator, passes a metallic dummy object through the aperture periodically, triggering and checking its own effectiveness, explains product manager Bob Ries.
Vendors are also pushing their ability to provide customized solutions and support. “When companies buy from us, they are getting a metal detection program,” says Mark D’Onofrio, VP and GM of Lock Inspection Systems (Fitchburg, Mass.). “This encompasses a quality inspection program, complete validation program, testing facilities, certified calibration program, and complete IT reporting.”Got 21 CFR Part 11?
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 it’s 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-rays
As they’ve 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, Safeline’s (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 radiation
Uncertainty lingers about whether or how radiation — even the low doses given off by today’s 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 Toledo’s product inspection division. Pharmaceutical clients of Safeline, a Mettler subsidiary, are in the process of “convincing themselves” of x-ray’s 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 it’s 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. “There’s 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.
Metal DetectorsBoekels Observer (at right)
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:
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 Pharmatron
The 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/PH21
Italy’s 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 Tec
The 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.Fortress Phantom Pharmaceutical
The Phantom has .3 mm sensitivity for stainless, and .15 mm for other metals. It has powered height and angle adjustment, and a high-speed reject mechanism.Goring Kerr DSP Rx (at right)
Thermo Electron’s Goring Kerr model for the pharmaceutical industry features a “quadrocoil” design, with two transmitter and receiver coils, allowing it to home in on the magic .25 mm mark for stainless steel contaminants that drug makers are looking for, says product manager Bob Ries.Lock Inspection’s MET 30+
The MET 30+ pharmaceutical unit outdoes the competition in terms of operating frequencies, says VP and GM Mark D’Onofrio, and frequency equals sensitivity. Lock provides a 1 MHz system, compared to a typical 600 to 800 KHz machine.
X-Ray UnitsLoma Systems’ Cintex Sentry XR
Loma bills the Sentry XR as a low-power “entry-level” x-ray unit for smaller items and lower volumes, with a “budget-friendly” cost.Safeline X-Ray Inspection Series 20 Pharma (at right)
The Series 20 performs multiple tasks, including inspection for multiple contaminants, density variations, and missing or damaged product in packaging.Smiths Heimann Eagle Combo
The Eagle Combo x-ray inspection device is one of the company’s smaller models, intended to replace the metal detector/checkweigher combination for monitoring smaller packages such as bottles or blister packs.