From his office window, Scott Titzer hopes he’s seeing the future of Infinity Molding & Assembly (Mt. Vernon, IN) as construction of a new, standalone cleanroom begins.
When MPW spoke with Titzer, VP of business development for the 27-year-old custom injection molder, concrete was being poured for an 11,250-ft2 addition that will feature a class 10,000 (ISO 7) cleanroom, accelerating the company’s drive to diversify its customer base at a time when any investment can seem foolhardy.
“I keep looking out my window, seeing all the construction activity and thinking, ‘Boy, we’re going to look like heroes or look like something else, if this doesn’t go the way it’s supposed to,’” Titzer admits. Titzer says the company is in a stable enough financial position to bite off the investment – about $1.9 million including the building, two 100-ton Engel e-Motion electric molding machines, and integrated Staübli robotics – which was preceded by a lengthy research process.
In addition to leaning on Randy Calvert, the company’s director of sales and marketing who has nearly two decades of experience in medical, Infinity got its hands on as much information as possible, vetted multiple suppliers, and even visited cleanroom facilities to glean best practices. The research also included characterization of the local cleanroom molding landscape. “We drew a 300-mile circle around our location, and there were four custom cleanrooms in that area,” Titzer says, “and none doing class 10,000.”
Based on that research, the company decided on a completely new building, with a modular, 2000-ft2 room that can be expanded, if necessary, and offers class 10,000 air throughout with some localized sections getting down to class 1000.
The company could have reconfigured space in its existing facility, which runs 40 machines ranging from 35 to 610 tons of clamp force, but Titzer said their research indicated that a from-scratch building, while costing more, represented a better strategy.
“The existing-space routine, you’ve got to overcome the housekeeping culture that usually gets ingrained in a company,” Titzer explains, “and as clean as we’d like to think we are, we’re not nearly clean enough to be a cleanroom.”
Based on flexibility, Infinity also opted for a modular room, which uses extruded aluminum and painted sheet metal structures with pre-finished wall sections that drop in place. The ceiling is modular as well, so that a tile can be moved and replaced with a filter, light fixture, and such. In addition, the room sits inside a fully conditioned building, including airlocks on all the exterior doors, so that all the air inside is temperature and humidity controlled. The molding area will use a single-pass filtration system, with 50-60 air turns/hr in the room itself. The air is pulled out of the room through pre-filters and then through the HEPA system. “Some people put a separate heating/air-conditioning system in for the specific room,” Titzer says, “and we chose not to do it that way based on recommendations and things we had seen with existing rooms.” Beyond the physical changes, from an administrative and process standpoint, Infinity also completed ISO 13845 registration within two months.
Among the companies Infinity consulted when deciding how to build its cleanroom were some existing medical customers who appreciated the time and money being invested. “[The medical customers] said there are not a lot of people that truly make the full investment to do it the proper way,” Titzer explains. “They say a lot of people try to do smoke and mirrors, and you can recognize that very quickly.”
Validating the amount of homework Infinity did to inform its cleanroom design, Don Detwiler, sales manager for Cleanroom Filters & Supplies (CFS; Bethlehem, PA), says there are several key questions processors must consider before hanging a cleanroom shingle.
First and foremost, what level of cleanliness will actually be needed, remembering it might not be the same for all phases. Processors should then consider the required work flow and how much area will be needed, before deciding on the type of cleanroom that will be used—softwall, thinwall modular, insulated modular, or drywall construction (for more on these, see box, above left). At this point, processors need to consider the level of temperature and/or humidity control that will be needed, considering also future requirements, including technical, product changes, and new opportunities. Finally, Detwiler says shops need to think about the effect the room will have on other operations in their plant; how they will design and build the room (contracting internally or externally); and the effects of varying depreciation rates for the investment.
Depending on the funding, design, engineering, permitting, and other factors, the timeline and budget for a cleanroom can vary widely, according to Detwiler. But as a general rule, Detwiler says a normal time frame for an ISO 7 (Class 10,000) 10,000-ft2 room with interior height not exceeding 12 ft that’s installed within an existing building would be four to 12 months. The cost would range from $100 to $250/ft2, depending on the amount of auxiliary equipment to be added.
In terms of ongoing energy costs, Detwiler says, roughly speaking, that a 10,000-ft2 at-rest ISO seven-room, with an 8-ft ceiling (80,000 ft3), can be expected to add approximately 10 to 15 tons of heat load to the refrigeration system, assuming 50 to 60 air changes/hr and a room temperature of 20°C (68°F).
Avoiding cleanroom headaches
For any shops interested in adding cleanroom processing, both Titzer at Infinity and Detwiler at CFS have some advice. “The design, development, and construction of a good cleanroom is not that difficult, but it is a combination of proper engineering and experience,” Detwiler says. “Like any specialty, it saves time and money if people with cleanroom experience are brought in at the beginning of the project.” Such specialists can help with the level of cleanroom chosen, which is ultimately a very important decision.
“It’s one thing to take a room designed to go to class 1000 and turn it into class 100,000,” Titzer says. “Don’t try to take a class 100,000 room and turn it into a class 1000 room – shoot for the higher mark, and if you don’t quite make it, you’ve still got something you can work with. If you go the other way around you’re doomed.”
That said, Detwiler adds that you do not want to classify the area to any higher level than is required by the customer or regulation because you will be required to certify the area to that higher level. “This does not mean you cannot design the area for a higher level of cleanliness to ensure compliance and/or to reduce rejections,” Detwiler says. “We often design spaces to the next higher cleanliness level since it’s usually inexpensive to do and will often allow you to upgrade the space downstream.”
Above all, Titzer says, you have to be willing to spend a little money. “Do your best not to skimp,” Titzer advises. “You can be price conscious about what you buy, but don’t skimp on what you put in that room, because I think if you skimp on your room or your scheme – you skimp on your facilities – you’ll have less than what you really want.”—[email protected]