After the sale: Distributors as troubleshooters

Distribution

It's a win/win situation when users turn to their distributors for help in solving cleanroom application problems. Users get an invaluable resource, while distributors get a chance to cement relationships

by Sheila Galatowitsch

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One user had a high particle reading in a processing area, but did not know the source. Another had an unexplained surge in bacterial counts. In both cases, the users looked outside the cleanroom for help, turning to their distributors for possible solutions.

Distributors routinely work with their customers to answer contamination-control application questions before a cleanroom goes online, but they also work to solve problems after a cleanroom is operational and the customer/supplier relationship is established.

“Our value is not only in our products, but also in our ability to help customers solve problems. And the more we help customers solve problems, the more they come back to us with new situations,” says Eileen Caffery, a principal at Benchmark Products Inc. (Highwood, IL).

“When customers call us for ideas, they know the symptoms-increased contamination levels and lower yields-but not the root cause of a problem,” says Mike Gaburo, vice president of the cleanroom division of Cintas Corp. (Cincinnati, OH), a consumables distributor and cleanroom garment supplier. “The value of the distributor in a troubleshooting situation is that we are an 'enlightened outsider.' We are in a lot of cleanrooms every week, exposed to myriad contamination control problems and solutions. Plus, we have access to lots of different products to attack a problem.”

A common problem is mysterious high particle counts. Recently, a customer in a government facility called Cindy Weist, president of Western State Sales Inc. (Denver, CO), about a vinyl floor that seemed either to be degrading or somehow emitting contamination. Weist sent cleaning materials to ensure that the floor was being thoroughly cleaned. She waits to hear the results, and if better cleaning doesn't prove a fix, she has other remedies at hand. “That's what being a good distributor is all about,” Weist says, adding that she gets at least one call per week from customers with application questions. Also, she is frequently asked to troubleshoot on her regular visits to customer sites.


A number of tests can be performed on garments to determine if the garments are doing their job.
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When customers call Liberty Industries Inc. (East Berlin, CT) about unexplained high particle counts, Cathy Albano, Liberty's channel distribution product manager, runs down a checklist of possible sources. “I will ask them, 'Where are you testing? Who is doing the testing? How often are you calibrating your particle counter? How often are you changing the filters and prefilters?' The biggest part of troubleshooting is educating people on cleanroom basics.”

While Albano says she gets several troubleshooting calls per day, the number of users seeking help has decreased significantly over the past five years, according to Liberty CEO John Nappi. “There used to be a lot of consultation and troubleshooting, but today's users seem to care only about price.”

At Prudential Cleanroom Services (PCS; Irvine, CA), customers often use the garment supplier's cleanroom testing facilities as an adjunct laboratory to their own testing efforts, says Elisabeth Knott, general manager of the PCS cleanroom garment processing facility in Richmond, VA.

“They are typically concerned about particulation problems and failures within the fab,” says Knott. “They will call us for help with identifying the type of particle and use us as an independent source to determine where the failure is-even if it doesn't involve garments.” PCS's five ISO Class 3 cleanrooms perform a wide range of industry-standard tests, including body box, microscopic inspection and liquid extraction methodologies, as well as the Helmke drum test.

Value-added services
Sometimes, users are looking for a product to solve a problem-but the product doesn't exist.

When one of Benchmark's sterile manufacturing customers reported problems with goggles, it collaborated with its supplier partners to develop a solution. “In a sterile environment, the cleanroom operator is required to be gowned from head to toe, including goggles, but goggles are a challenge,” explains Caffery. “They need to be sterile, so users wipe them down with alcohol or put them in an ultraviolet (UV) cabinet for several hours, but that doesn't guarantee sterility. Apart from sterility concerns, the goggles fog up and are uncomfortable when worn.”

After a lot of legwork, Benchmark and its manufacturing partners came up with a sterilized, single-use goggle that has a more breathable, fog-free face. Most distributors can help customers get a start at looking at potential sources of contamination. “It's important that distributors play that role, but sometimes you need to bring in other technical experts,” continues Caffery. “That's what we did in this case by working with outside consultants and manufacturers. It's important to know who to go to for help.”


Shown here is a QA technician conducting a Helmke Drum test.
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That's also the philosophy of garment and laundry supplier Aramark Cleanroom Services (Burr Ridge, IL), which has created an in-house quality assurance network to help customers solve their apparel-related application problems.

Each Aramark user has a regional service manager as a dedicated point-of-contact. When a user queries the service manager about a problem, the manager can turn to one of three Aramark market centers in the United States. At each center, cleanroom technicians run myriad laboratory tests, supervised by a quality-assurance manager, who reports to Aramark's national director of quality assurance-a microbiologist himself. The 15-member network's “only job is to solve problems and ensure our laundering process is working,” says John Demos, national sales manager at Aramark.

For example, when the FDA told an Aramark biotech customer to restrict garments used in the sterile fill department to that department only, the user took the problem to Aramark. “The FDA wanted the company to make it very apparent that the garments going into that department were solely earmarked for that department,” says Demos. Once when a customer brought the issue to the regional service manager's attention, she suggested going to a different color garment for that department. “They were able to exchange the stock garments they had and just replace them with a different color,” he says. “It was a very important problem, but the fix was simple.”

Other problems are more complex. Demos says if a customer is getting particle or bioburden readings above their standards, Aramark can perform a number of tests on their garments to determine if the garments are failing or if it's something else in their process that is creating a particle or microbial problem. If necessary, the QA managers will visit the cleanroom and make recommendations.


At Aramark's market centers, cleanroom technicians run laboratory tests.
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That's what happened when another Aramark pharmaceutical customer noticed high bacterial counts in the cleanroom. On-site visits and lab testing proved the source of the contamination was street clothes worn under cleanroom garments. “People were walking into the gowning room after mowing the lawn and petting the dog. We recommended dedicated cleanroom undergarments, which drastically improved the bacterial problems,” says Demos.

Its pharmaceutical and biotech customers often call with concerns about cross-contamination among a facility's cleanrooms, especially after a facility adds new manufacturing space. Demos says Aramark solves this problem by treating each cleanroom as a separate customer, bar-coding, then automatically scanning each cleanroom's garments to ensure they don't commingle during the laundering process.

For some users, particles are more of an aesthetic than a contamination problem. Innotech Products (Minneapolis, MN) this year got a call from a medical device customer that packages a product for later sterilization. The problem: visual particles were being sealed inside of the package. “In this specific case, the particles trapped within the package were more of a cosmetic issue than a quality issue,” says Brian Weist, Innotech president. “They called me in to assist in analyzing how their process could be changed to avoid this problem. We made some suggestions in terms of procedures and airflow changes.”

Weist says most of Innotech's trouble shooting calls come from small to mid-size companies, which can benefit the most from using their distributor's expertise as a value-added resource. To ensure troubleshooting support is there when they need it, users should evaluate a distributor's background, strengths and willingness to offer help after the sale during the supplier selection process itself.

It's not only business, it's personal
For distributors, helping customers solve problems is a powerful way to personalize a business that, recently, has gone virtual.

“With the e-commerce aspect of the business, many of the consumable products are becoming more of a commodity item in the eyes of users. They can go to numerous Web sites and buy gloves, swabs or wipers anywhere in the United States,” says Western States Sales' Weist. “For a distributor to retain and expand its customer base, it absolutely needs to offer value-added services; and in our case, that means contamination-control expertise.”

In coming years, most distributors expect their roles as troubleshooters to expand as contamination-control requirements grow ever more stringent.

“On the pharmaceutical side, FDA regulations are getting tougher, creating more problems to solve,” says Cintas' Gaburo. “On the electronics side, the product is more delicate and susceptible to contamination. And there are fewer people around to solve problems internally than there were five years ago.”

Both user groups will need to increase their reliance on outsiders for problem-solving help. Distributors admit they will never be surrogates for a contamination-control engineer or a quality manager. A distributor is not an expert at what its customers do, but its trucks stop at a lot of doors, the advice is free, and it offers a lot of things in its bag that might make the patient feel better.


Sheila Galatowitsch is a special correspondent to CleanRooms magazine.

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