Winner: Reliable pH sensor improves product, process and profits
As a member of the Degussa Fine Chemicals Division, Raylo’s Edmonton, Alberta facility is Current Good Manufacturing Practices (CGMP) certified. All the production equipment must be tested and certified, which involves a strict qualification process for regulatory compliance and regular audits by the U.S. FDA. “The majority of our business involves exports to the United States. If we don’t receive FDA approval, we will go out of business,” says Rob Pastushak, senior technical supervisor of pharmaceutical manufacturing for Raylo. “We must clearly demonstrate that we control every aspect of our manufacturing process at all times, and that our instruments are properly calibrated on a regular basis.”
To assure consistent product quality and maximize batch yields, Raylo launched an effort in 2003 to improve the efficiency of its manufacturing process. Pastushak focused on pH measurement.
“Measuring pH was a problem at that time because of the unreliability of our pH sensors. They simply could not hold up under the aggressive chemicals that we use, such as hydrobromic acid,” Pastushak says. “The organic solvent constituent caused the probe’s O-rings to degrade during the most critical point of the process. In many cases, three probes, at approximately $600 per probe, would fail while processing just one batch.” Once the O-ring degraded, the pH probes no longer provided accurate readings.
To resolve the pH measurement issue, Pastushak researched several probes and decided to test the Foxboro 871PH Series sensor, from the Measurements and Instruments Division of Invensys Process Systems. The 871 is a rebuildable pH probe that incorporates patented technology from the award-winning Foxboro DolpHin pH sensor line.
Raylo put the Foxboro 871PH through extensive testing before integrating the unit into the manufacturing process. During an initial one-month test, Raylo discovered that the 871PH allowed them to control pH faster because it adjusted to solution changes more quickly. “The results have been consistent from batch to batch,” says Pastushak. “As soon as we add a solution to adjust pH, the probe responds immediately and provides the new pH reading. We’ve found it to be accurate within 0.03 pH units, which is well within our target limits.
“We can now complete a pH adjustment in three hours rather than the 18 hours to 24 hours it previously took,” says Pastushak. “And we no longer have to take 40 samples to the lab to confirm measurement accuracy — we only take one, as a matter of quality assurance protocol.”
The 871PH sensor also is very durable, according to Pastushak. “The one we deployed two years ago looks like it did the day we bought it,” he says. “All we do is clean it after each use. The Ryton bodies are holding up extremely well. They display no degradation, pitting or corrosion, even though we run the gamut of pH ranges, solvents and aggressive conditions.”
During the past two years, Raylo has replaced three legacy probes within its manufacturing process and plans to replace three more. The company has a second manufacturing facility with 15 probes that will eventually be swapped out.
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