By Wendy Meyerhoff
When Ortho-Clinical Diagnostics saw a major increase in product availability, it also faced a challenge: how to process all those products for shipment quickly and still maintain sanitation standards.
“In 2005 we saw a 50% increase in the volume of testing,” says Angela Housel, a scientist who was working in quality/microbiology at Ortho-Clinical Diagnostic (OCD), based in Rochester, NY. “We provide all sorts of diagnostic tests to various healthcare environments, including hospitals, doctors’ offices, and labs. We had taken on new product lines, and suddenly we had to determine how to increase productivity in the laboratory.”
That sounds like good news, but it presented Housel and her group with a dilemma. “We had to continue to release quality product to our customers but release it more quickly. Using the traditional filtration methods for microorganisms, the results took about a week,” says Housel. That meant keeping product stored while completing the testing, which not only increased outlay for storage fees but delayed shipment of product. “I was tasked with figuring out how to release these products more quickly.”
Seeking Speed Plus Accuracy
To do her research, Housel had both the Internet and a special advantage, as OCD is part of the vast J&J network. “I collaborated with other scientists in the company. I made phone calls and read papers and eventually found someone who had already done a lot of this research,” she says. It wasn’t a quick process. “It took about a year to read through everything,” she adds.
Housel was very interested in anything that would allow her group to minimize testing time. “In traditional bioburden testing, microbial colonies have to be cultured for five to seven days before they’re large enough to be physically counted with the human eye,” says Wayne Miller, field marketing manager for Millipore, a company that manufactures rapid microbiology detection systems for such testing.
Technology Vs. The Human Eye
“Around 2003, we launched a rapid bioburden detection system, called Milliflex Rapid, a modification of the Milliflex bioburden family system we already had in place. It’s based on the ATP (adenosine triphosphate) bioluminescence protocol that’s familiar to the food service industry and which has started making its way into pharmaceuticals,” says Miller.
ATP is an energy molecule stored in all microorganisms. For the more rapid procedure, the organisms are filtered and incubated on a selected medium, such as a slide or petri dish. This selected medium is then sprayed with two reagents: one that releases ATP and one that creates bioluminescence.
Thanks to the resulting light reaction, a CCD camera can see the microbial colonies in as few as 16 hours, instead of the week it takes for them to grow large enough for the eye to see. A computer doing the count lends additional accuracy. “With the 16-hour testing, we saw faster turnaround and inventory reduction, so there’s less warehousing,” says Housel.
Every product needn’t be tested. Housel’s team established basic criteria for testing outcomes. These included base matrices, antimicrobial levels, pH readouts, and chemical makeup.
Besides moving actual inventory, the system allows for another speed issue. “It is easier to monitor raw materials to see if they’re pure [i.e. making sure water is clean]. And the turnaround time for being able to use or reuse these materials becomes faster,” says Miller.
If a CFO or other decision maker is looking strictly at the initial costs of implementing this type of testing, then their first inclination might be to pass, especially in this economy. Miller says that’s a shortsighted decision. “The Rapid is more expensive to implement, but a number of things justify the initial outlay,” says Miller.
First, there are the changes that provide the most obvious financial benefits. Some of those benefits include:
- Reduced testing times. Depending on the product, the testing time drops from up to two weeks to no more than two days. Daily testing can be implemented if necessary.
- Flexibility in reacting to supply chain issues. “The older testing method often caused a bottleneck in the release process due to waiting time for the cultures to incubate,” says Housel. That led to shipping delays and loss of revenue due to back orders.
- Reduced warehouse costs. Products don’t sit as long in holding centers waiting for testing completion. “We didn’t see as much unnecessary inventory and carrying costs,” says Housel.
- Improved testing quality. “The quality of the test is better. There’s a decrease in cross-contamination, and filtration is faster,” Housel says.
- Greater team reliability. “We have better capability to react to the supply team’s issues regarding back orders. When someone calls and says ‘We need this product,’ we can say with confidence, ‘I can have it ready for you quickly,’” Housel says.
It also isn’t that difficult to learn. “You’re still using the U.S. Pharmacopeia steps for validation. Follow those seven steps, and you’re fine,” says Miller. Housel adds that the IQ/OQ protocols were already there. “We didn’t have to write our own, which takes a lot of time,” she says. All in all, such details help improve the onset of the actual start date from the time of purchase.
Corporate decision makers also need to be looking to the future. Regulatory issues may soon be spurring a trend toward rapid testing. “The PAT [process analytical technology] initiative from the FDA is already encouraging it,” says Miller. According to OCD’s validation paper, PAT is “a risk-based, in-process measurement of materials and process controls through the use of rapid microbiology methods.”
Time reduction was important, but Housel needed a system that met other criteria as well. “I set up a prioritization method to determine what was most important. I ultimately decided I also needed three other things for our system. It needed to offer Part 11 compliance, to provide the number of colonies in the sample, and to be compatible with existing products,” she explains.
That compatibility is important. “The supplier should be willing to do a compatibility study. With this Milliflex Rapid system, for example, if you use a dilution broth or have a product with certain microorganisms, there might be some interference with the system. Make sure there’s no extraneous ATP that you’re going to be testing. Water is no problem, but you may be using something else,” Housel says.
Housel has since moved to another area of quality control, but emphasizes that her research garnered extensive interest. “First, I presented it to a group of J&J microbiologists and got several requests for more details. Since then I’ve gotten other messages asking, ‘How did you do it?’ Ultimately, I even got to present the details to the company president,” she says.