Focus: MedicalBasic Elements: What you should know before setting up your cleanroom

Building a clean facility involves much more than a few Hepa filters.

So, you think you should add cleanroom molding to your plate of capabilities in hopes of landing that big medical job? Medical molding is still the primary reason molders add cleanroom capabilities. Since the FDA regulates much of the quality and good manufacturing practices (GMPs), medical molding means complying with many regulatory demands.

Deciding on the classification of a cleanroom is often a function of your customers’ requirements. To decide to put in a Class 100,000 cleanroom just to be able to say you have one in the hope that it will attract medical or optical molding business is the wrong way to go about it.Ralph Kraft, president of Cleanroom Services Inc. (Rochester, NY), says that often people don’t know what they’re buying when they start looking at cleanroom installations. “They’ll say they need a certain classification of clean, when in reality they might not,” he explains.

Kraft points out the changes in the standards. “We’ve gone through a change from the Federal standard to the ISO standard,” he explains. “The standard for a Class 10 cleanroom is now equal to ISO 14644-1, level 3.” As a comparison, a typical living room is equal to about Class 250,000.

Know the Costs

Cleanrooms are not inexpensive to operate and maintain. “There’s a big difference between the purchase price of a cleanroom and operating it and maintaining it,” Kraft cautions.

Robert Heraldez, maintenance manager for Trademark Plastics (Riverside, CA), is in charge of the company’s cleanrooms, and concurs with Kraft. A separate, full-time janitorial staff is required to keep the cleanroom up to standards. Then there is the clothing: coats, booties, and hairnets for all personnel and visitors (see “Fixed costs,” below).

Additionally, Hepa filters, which control airborne particulates, are expensive and require frequent replacement. “Ordinarily, depending on the manufacturer and physical plant location, a good filter might last three to five years,” says Heraldez. He relates that there is disagreement in the industry with respect to older filters; some believe the older they are, the better they perform. “As filters get clogged they screen more, smaller particulates,” he explains, “but this can also block airflow, impeding circulation.”

Expensive prefilters are generally required for higher-classification (10,000) cleanrooms. “By design they absorb the majority of particulates, so they need to be replaced every two to three months,” says Heraldez. “There’s considerable expense in that, as each one costs about $8. We have 40 to 50 filters.”

Then, there is the cost of certification and testing. Trademark performs quarterly testing for particulate levels in both cleanrooms, and an additional bio-burdens test for its Class 10,000 cleanroom, which Heraldez says is quite an expensive test done by an outside lab.

Know the Scope

Roughly, the annual cost of maintaining cleanrooms the size of Trademark’s (one 9780-sq-ft Class 100,000 and one 6855-sq-ft Class 10,000) is about $88,000. Larger cleanrooms require exponentially more to maintain.

“If you cut corners in construction, it compromises the integrity of the cleanroom, and you have a harder time getting certified,” Heraldez says. “Also, if your CR is marginally in a class your customers require, some won’t deal with you. There are costs in installing a cleanroom with integrity and thoroughness.”

Cal-Mold (Mira Loma, CA) implemented a strategic plan for its medical molding business that included the addition of a state-of-the-art cleanroom molding facility. The 5300-sq-ft, Class 10,000 cleanroom was recently certified, and brings the company’s total square footage to 170,000, making Cal-Mold one of the largest medical molders on the West Coast. ( See September 2002 IMM for an initial report.)

The cleanroom features 56 Hepa filters supported by five industrial air handlers, large-capacity overhead bridge crane service, dual air locks front and back, specially designed clean pack-out areas, an automatic finished parts conveying system, streamlined utility service to each machine, a modern pass-through inspection window, and an automated post-gowning air shower to ensure efficiency and cleanliness. The new cleanroom is equipped with all-electric injection molding machines from JSW including one 60-ton EL, one 120-ton EL, and one 200-ton EL.

There are less expensive ways to go, such as draping the press in what is called a “portable cleanroom” that might also be equipped with airflow filters over the press to reduce particulates. These typically can get an area to a Class 100,000 level.