Gaining Access to Cleanroom Molding

Astronomy buffs no doubt recall NASA’s Hubble Space Telescope, and a malfunction that prevented the billion-dollar device from “seeing” clearly once in orbit around the Earth. What some may not recall, however, is the cause of the problem: a lapse in cleanroom procedure that allowed a particle 200 times smaller than a human hair to contaminate the telescope lens during manufacturing.

This level of exactitude has probably discouraged more than one custom molder from pursuing opportunities in cleanroom molding of medical components over the years. For the small number that did venture down this path, meanwhile, the process was usually seen as little more than a niche market.

Today, however, the lure of medical molding is growing. With a generation of aging baby boomers increasingly in need of regular medical attention, and oftentimes of invasive surgical procedures, the demand for critical medical components is on the rise, making for what may be a recession-proof market.

And the price of entry into this market is a cleanroom.

A QUESTION OF COST

This doesn’t mean, however, that the process of installing a cleanroom is easy.

According to Ralph Kraft, president of cleanroom services provider R. Kraft Inc., molders looking to make cleanroom parts need to not only have a clear business strategy, but also an understanding of the cleanroom layout that will suit them best, as well as the costs involved. “Most companies don’t realize the commitment they have to make, and get halfway through the planning process before deciding it costs too much money,” Kraft said. “In order for it to work, management has to be sure it makes good business sense.”

The best way for a molder to begin is by contacting a cleanroom supplier. “There are a lot of suppliers out there, and they’re happy to help,” said Brian Holmes, vice president of operations at custom molder Columbia Plastics Ltd., which began cleanroom molding last year. “We spoke with a several before selecting the best one for us; it was no different than choosing processing equipment.”

Molders committed to the project must realize that it will not be cheap. The average investment for a Class 10,000 permanent hardwall cleanroom is approximately US$500,000, Ralph Kraft said, a figure largely determined by square footage, as well as standard of cleanliness. This can lead to problems right away, as companies might attempt to downsize the cleanroom to save money. “Too many companies think they can set up their cleanroom in a closet-sized space, which they proceed to ruin by overpopulating with equipment and personnel,” he said.

An additional factor driving price is the type of cleanroom selected. A portable, soft-wall cleanroom — essentially drapes around a press — is usually more economical than a hardwall cleanroom, which is built permanently into a manufacturing facility.

CLASS STRUGGLE

Another key question is selecting the certification level of cleanroom to be installed, which is determined by the number of airborne particulates in a given area.

Many molders opt for a Class 100,000 cleanroom, which is equivalent to an ISO 14644-1 level 8. According to Ralph Kraft, this is a cost-effective level at which to enter cleanroom molding. “Lately, though, I’ve seen a push among custom molders towards Class 10,000, which is a higher level of standard, demanding fewer particulates, and opening up new possibilities for molding of more critical parts,” he noted. Put in everyday terms, typical office building air contains from 500,000 to 1,000,000 particles (0.5 microns or larger) per cubic foot of air; Class 10,000 cleanrooms are designed to limit particles to 10,000. Achieving Class 10,000 standard or better requires a greater investment in the air exchange systems and filtering devices that, by clearing particulates, are the backbone of any cleanroom.

For molders installing a hardwall cleanroom, another question centres on location. This is generally determined by the available space, along with the company’s particular preference. An eye should also be kept on marketing considerations, Ralph Kraft said. “The cleanroom has to be in a place conducive to marketing itself, because it is a marketing tool,” he noted. “Perception is important to impressing potential customers, and a good cleanroom can be the showpiece of a production facility.”

OTHER CONSIDERATIONS

Kraft suggests building a hardwall cleanroom with interior windows for looking in, but without windows facing outdoors, as seasonal lighting can affect cleanroom conditions. Space will also have to be set aside for a gowning area, in which employees suit up in proper attire before entering the cleanroom.

On average, construction of a hardwall cleanroom will take approximately 20 weeks, Kraft said. While this may interrupt production runs, a good installation team will minimize disruption by hanging curtains as buffers between the construction area and the rest of the facility. Once construction is complete, the room is precision cleaned and then certified, usually by the cleanroom service provider.

A final, critical step is the proper training of employees for work in the cleanroom environment. “Training is key, because instead of lawn chairs you’re now molding something that is potentially going inside a human body,” said Richard Boon, sales and marketing manager with Columbia Plastics. “Having an in-house training program is crucial because there are so many protocols and disciplines that have to be followed.”

ATTRACTING CUSTOMERS

Achieving a certified cleanroom with trained employees is still just the beginning, however. For most custom molders, the next step is the search for customers. “Usually, a company has to have a cleanroom before it can secure a molding contract,” Richard Boon said. “Very few customers will give you a job on the premise that you are going to then go out and get a cleanroom.”

Generally, Boon continued, potential customers will want as much information as they can get about a prospective cleanroom molder, especially regarding the molder’s ISO program. “Potential customers will want to see how long you’ve had ISO, and how well your procedures are being followed,” he said. Most will expect a minimum ISO 9001-2000 standard. “If you don’t have that, they probably will not be satisfied,” Boon continued. “It was made clear to us that if we did not have a solid quality control program, we were wasting our time.”

Another potential drawback centres on the need for constant quality control, due to the strict FDA-mandated protocols set out for most medical components. Regular audits are the norm. “Customers will either have an independent audit of a cleanroom carried out, usually every six months, or allow the company to perform a self-audit,” said Columbia Plastics’ Brian Holmes. “Either way, such factors as particulate count are always closely monitored.”

GOLDEN OPPORTUNITY

On the plus side — and largely because of these audits — North American molders that persevere with cleanroom molding enjoy a rare advantage over Asian competition. “Because of the liability risk, customers prefer to have medical components made in North America,” said Richard Boon. “Asian custom molders can’t always guarantee quality in critical care parts. This givesus a huge opportunity.”

CPL

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Resource List

Columbia Plastics Ltd. (Surrey, B. C.); www.columbiaplastics.com; 604-530-9990

R. Kraft Inc. (Rochester, N. Y.); www.cleanroomservices.com; 800-447-4754