Accuracy Outsourced

Angelo De Palma, Ph.D., Contributing Editor

So, Instrument Calibration Isn't Your Core Competency? Here's What to Look for in a Third-Party Service Provider

Calibration makes the world of test and measurement go 'round, and with it, every industry that relies on precise metrics. Every result in pharmaceuticals, from discovery through clinical trials, is only as good as the instrument that measures it.

"Life science companies live and die by measurements," says William T. Thomas, National Sales Manager for Life Sciences at SIMCO Electronics, Billerica, Mass. Yet most scientists and engineers hardly ever think of calibration. Nor do they notice the guys with the funny suitcases who keep the tools of laboratory and manufacturing measurement accurate, reliable and reproducible--while documenting that they have done so, of course.

In the calibration hierarchy, national standards organizations such as the National Institute of Standards and Technology (NIST) are at the top, followed by National Laboratories and large calibration equipment manufacturers such as Fluke and Agilent. Next are most third-party calibration service providers, followed finally by end-user companies. Organizations at each level rely on those "above" them to calibrate their instruments and calibrators.

"Our assets are about four times as accurate as end-users'--and NIST's are about four times as accurate as ours," says Keith Hadley, director of business development at calibration service provider Transcat, Rochester, N.Y.

Indeed, every large pharmaceutical company has a metrology/calibration department, although such groups sometimes often don't go by that name and may report to quality assurance/quality control, engineering, facilities or instrument maintenance departments. Calibration crews tend to be small, so at larger firms they devote their time to a few specialized calibration services and outsource the remainder.

The Outsourcing Threshold

Before hiring a third-party to perform calibration services, pharmaceutical companies should take stock of their in-house calibration capabilities and determine precisely what they need to outsource. This purely economic decision should be based on costs of hiring and training calibration personnel, obtaining appropriate certifications for instruments and workers, and acquiring/maintaining in-house standards.

A good first exercise for companies perplexed about acquiring such services is to estimate their costs for calibrating 1,000 balances or pipettes per year, then compare that to the cost of having someone else do it.

"They may decide that their instrument shop can handle the chromatographs and spectrophotometers, but not temperature and pressure controllers," notes, Jim Erickson, CEO of calibration software provider Blue Mountain Quality Resources, State College, Pa. Types and complexity of calibration also enter the equation. For example, calibrating balances is relatively straightforward, while fine-tuning processing and control instruments requires more sophisticated standards and calibration methods

Most pharmaceutical manufacturers realize that in-house calibration groups are cost centers with significant overhead. "Many companies, when they reach a critical mass, can achieve significant cost savings by outsourcing," says William Thomas of SIMCO.

Measuring Up Services

Once a firm decides it needs a calibration service provider, primary considerations include the right mix of services, timeliness, geographic coverage and cost. As bare-minimum requirements, drug makers expect traceability to primary reference standards (NIST), instrument-specific expertise, documented quality assurance and technician training systems and certification to one ore more sets of guidelines such as ISO/IEC Guide 25, ISO/IEC 17025 or ANSI/NCSL Z540-1.

Such certifications are required by most industries today, although that was not always the case. John Bluemle of Wisco Calibration Services, Pittsburgh, Pa., tells of a steel maker some years back who required ISO 9001 certification which Wisco, then part of Westinghouse, was just then acquiring. "After we were certified, they sent us all their business. But when Westinghouse sold off its calibration unit we lost our certification, even though we were the same people using the same instrumentation and protocols." When the new entity balked at spending the time and expense of re-certification, the customer re-hired them anyway. "I guess it could have turned out to be a problem had this customer been audited by someone looking for our certifications," says Bluemle.

Next, manufacturers need to take a calibration inventory and match specific instrument/measurement needs with the potential service provider's expertise. At this stage, there is something to be said for consolidating services and providers--for example having one company handle all laboratory instruments and another all non-electronic measurement systems.

Given the pharmaceutical industry's prevalent merger-mania, a service provider's geographic coverage is important for manufacturers with multiple sites who desire consistency and centralized control over calibration services. If serving an entire organization is desirable, providers must offer similar services at different locations. In this business, consolidation equals efficiency: A single provider, while not necessary, may be ideal.

Small- and mid-sized manufacturers might consider the service provider's ability to provide comprehensive services to both R&D and manufacturing, particularly as companies or sites grow. "Many R&D or drug discovery organizations consist of autonomous research groups which are not coordinated to calibrate their instrumentation," notes SIMCO's Thomas. "Each research group has its own vendor relationships, which creates redundancy and cost inefficiencies."

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