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August 20, 2002
9 Min Read
Cleanroom molding became a buzzphrase for custom molders back in the mid 1980s when many began seeing an opportunity to mold medical devices. A molder that could say it had "cleanroom" molding was almost guaranteed to get medical work, a ticket to what was then viewed as recession-proof, domestic business.
However, for many custom molders, having cleanroom capabilities didn't make sense. Medical parts were only a small portion of their overall business. Portable cleanrooms, or drapes around a specific press, became popular as an alternative to making an entire production floor into a cleanroom. So what does makes sense for custom molders?
First, a molder needs to evaluate whether or not installing a cleanroom is critical to the business plan or marketing strategy. Does the majority of the customer base require cleanroom-molded parts? If so, what level is required? Class 100,000 or a clean environment? Class 10,000? 1000? The cost to install each level of cleanroom varies with the type required.
Ralph Kraft, president of R. Kraft Inc., a cleanroom services company headquartered in Rochester, NY, says that generally the customer dictates whether or not a molder needs a cleanroom, and the level. Selecting a level without specific customer input can result in a cleanroom that is more or less than what is required. Many molders opt for a Class 100,000 cleanroom, a cost-effective level at which to enter cleanroom molding. Class 100,000 is the equivalent of an ISO 14644-1 level 8. (Kraft notes that the ISO standards are typically used now rather than the federal standards; see Tables 1, 2, and 3.)
Table 1. Federal Standard 209 class limits
Because of the liability risk, most medical OEMs do critical molding in-house where higher levels of cleanroom standards (Class 1000 to Class 1) are required. It also allows them to keep close tabs on the FDA-mandated GMPs required for manufacturing "critical care" components, such as those used in angioplasty. That leaves the not-so-critical parts for custom molders, which means clean environment molding might be good enough, without the expense of a certified cleanroom.
What's Really Clean?
Remember that customers generally won't pay more for something that does not provide value to them. Don Hoverter, sales manager for Henry Plastic Molding Inc. (Fremont, CA), discovered this as his company debated adding cleanroom molding. "One customer asked us to quote a part cleanroom molded, but he didn't like the higher price," he says. "Not one of our other medical customers requires it, so we're not sure just how much need there is out there for cleanroom molding."
Currently, Henry Plastic Molding offers portable cleanrooms that can fit around about 15 of the company's 23 molding presses (22 to 300 tons) to provide the equivalent of Class 100,000. The company also recently completed a 600-sq-ft cleanroom assembly area that is certified as Class 100,000.
Kraft acknowledges that many molders opt to go with a portable, soft-wall cleanroom because it's a quick, economical fix. And when it comes to certification, some molders considering a Class 100,000 environment question how much cleaner that is than the already clean molding facility they currently operate.
Steve Michaels, regional manager for cleanroom supplier National Cleanroom Inc. (Hialeah, FL), notes that in the injection molding business, "we're usually talking about an environmentally controlled room-temperature and humidity-not really a clean room." But for a few exceptions (NASA and Intel, for example), few of Michaels' customers know exactly what they require in a clean environment, and that most choose Class 100,000. "A Class 100,000 cleanroom, in my world, is at the low end of the cleanroom spectrum," says Michaels. "Your home is almost that clean, yet that's what they choose because it's budget driven."
Table 2. Selected ISO 14644-1 airborne particulate cleanliness classes for cleanrooms and clean zones
Barry Grant, president of Contour Plastics Inc. (Baldwin, WI), has plans to install a cleanroom in his molding facility, but remains ambivalent. "We've wanted to be in [cleanroom molding] for years, but why?" he says. "I still don't understand the benefits. Other molders have Class 100,000, which isn't much better than what we've got now."
The various levels of cleanroom certification have to do with the number of particulates in a given area (Table 1). A Class 100,000 cleanroom is the lowest level and contains a maximum of 100,000 .5-mm particles in a 1-cu-ft area. It's a little better than what molders call "clean environment" or "white room" molding, and is slightly cleaner than an office-typically around Class 125,000, depending on the amount of carpeting and other materials in the office, says Kraft.
Achieving Class 10,000 or better requires a bigger investment in air exchange systems, filtering devices, special clothing such as gowns, disposable booties, and hair coverings, and special housekeeping equipment, all of which raise costs considerably. Kraft says, for example, that soft-wall cleanroom prices range from $30 to $75/sq ft depending on size and classification of cleanliness. Ballpark cost for a 12-by-12-by-10-ft portable cleanroom might be $65/sq ft for a Class 10,000 category.
Michaels says when he's asked to provide a Class 100,000 cleanroom, "I know they're looking for eye candy. What they're saying is 'we want it cleanâ€”cleaner than the rest of the plantâ€”but don't want to spend a lot of money.'" For a hard-walled room that has temperature and humidity controls, filtered air, and so on, costs would be upwards of $150 to $160/sq ft or more. "There are so many variables that add costs to installing and maintaining a cleanroom," he notes.
First, there's the cost of training personnel in proper cleanroom protocol and disciplines to work in a cleanroom. "You need good, documented housekeeping procedures," Kraft warns. "In most cases an injection molder will be doing [cleanroom molding] for an FDA-regulated medical OEM, so documentation is critical and people have to be trained properly."
Cleanroom manufacturing buildings such as those used by semiconductor chip makers, says Kraft, can cost $3000 to $5000/ sq ft for Class 1. However, installing a cleanroom is only the beginning. He points to the need for and cost of replacement equipment such as Hepa filters and electricity to run the filter fans. There are also costs for ancillary space. "A cleanroom needs at least an 8-by-8-ft gowning area," says Kraft, "and that can be a problem because of the cost. People say 'why should I pay that kind of money for a closet?' You have to look at the cost of ownership, not just the purchase price."
Those costs are one reason why Grant looked for flexibility when ordering a cleanroom. Like most custom molders, he can't afford to put in a totally dedicated cleanroom to mold only cleanroom-mandated parts. Many molders find themselves molding other parts in their cleanroom so the presses don't sit idle waiting for the appropriate "clean" job.
Table 3. Comparison between selected equivalent classes (Source: Cleanroom Technology, by Bill Whyte)
Recently, Henry Plastic Molding installed a cleanroom assembly area, which has been qualified but so far doesn't have any work. "We got into it as an opportunity, but it's not our main focus," explains Hoverter. "[Cleanroom manufacturing] might be one of those things that you either have to get into with both feet or not at all."
Contour's Grant says his company has also viewed cleanroom molding in light of new opportunities it might provide. "We're trying to find niches in the marketplace, and [we've] been pushing to get more medical business because we see this as an area that is more recession proof and less sensitive to offshore competition," he explains.
Kraft says a lot of molders use the cleanroom as a marketing tool to attract business in an industry that values cleanroom manufacturing. Medical is one of those. In spite of the investment required, molders continue to see medical molding as a growing segment, and the promise of the Baby Boomer bubble as that population segment ages provides the carrot to serve that market.
Erik Fleming, president of Cal-Mold Inc. (Mira Loma, CA), points to the number of molders in the Southern California area with cleanrooms to mold for the still-booming medical industry. However, Fleming is under no illusion that just having a cleanroom will allow Cal-Mold to command premium prices.
"I don't think people will pay a premium for their parts," says Fleming, "but you will get business because of it. Medical appears to be a growing segment, and from what we hear, when everyone else is slow, medical is busy. Being in the medical market gives you more opportunities, and the price of entry into the medical market is the cleanroom."
Plans call for Cal-Mold to cut a section from each of its two, enclosed, 15,000-sq-ft molding areas to create a 5300-sq-ft cleanroom molding area. The primary infrastructure is in place such as climate control and enclosed conveying and automated material handling systems, notes Fleming.
"The incremental costs of sectioning off one area of the current molding rooms aren't as high as building an area from scratch," says Fleming. "Our feeling is that we're already incurring the majority of the burden in our custom molding operation, so the added burden for the incremental cost of a cleanroom vs. the opportunity for sales is a positive thing."
Having cleanroom molding capability used to be a differentiating factor among custom molders. As more molders add cleanrooms, however, it's the level of cleanliness that will be the differentiating factor. "We've made provisions to move to Class 10,000 in the future," says Fleming, acknowledging that some customers won't pay for a Class 10,000 level.
Like many custom molders who install cleanrooms as a value-adding service, Hoverter isn't completely convinced of the benefits. He notes that, although the company entered the cleanroom manufacturing arena cautiously and cost effectively, he's not sure it's the total answer for getting new business, even if it really takes off for the company. "We'll dabble in it and see what market is out there for it."
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