Tube and hose maker shoots for ISO Class 7, gets ISO Class 6
08/01/2002
Built To Spec
Manufacturer says clean, pure products is its "future"
by Mark A. DeSorbo
AdvantaPure, a Southampton, PA-maker of thermoplastic and thermoset tubing and hosing for the pharmaceutical, biomedical, cosmetic and food industries, got more than it bargained for when it set out to make its 2,500-square-foot ISO Class 8 cleanroom cleaner.
"We were hoping for ISO Class 7, so we put in extra HEPA filters, for a total of 40, and a third party determined it was actually operating at ISO Class 6," says Don Warner, director of marketing, AdvantaPure. "It did surprise us."
A third-party verifier, Micro-Clean Inc. (Lehigh, PA), checked the cleanroom with particle counters in 15 different places, and found one "hot spot" near the extruder, the machine that forms the tube and hose.
Design improvements
"The extruder has a cooling fan and it was venting air and dust, so we had to install a duct to exhaust outside the cleanroom," Warner says.
HEPA filters and a little ductwork were not the only things the in-house-designed upgrade called for. In fact, the $450,000 renovation also included a sealed, drop-tiled ceiling, and several coats of epoxy over drywall paneling as well as epoxy flooring.
"We put in the sealed ceiling, painted the walls with epoxy and put down an epoxy floor, making the cleanroom easier to clean," says Michael Needling, a director of manufacturing at AdvantaPure.
Warner says cleanroom personnel, who wear lab jackets, booties, hairnets, beard nets and gloves, wipe down surfaces at least twice per week, while once every quarter, a cleaning service performs a complete sanitization of the environment.
The project also included the construction of a separate "white room" for storing raw materials and finished products.
"Everything is bagged at the end of the line and put into large plastic containers. Then, the plastic containers are stored in the white room, so everything is triple contained," Warner says. The white room, he says, has proven to be a better storage area than AdvantaPure's 50,000-square-foot warehouse. "It's a closed room, so there's no foot-traffic, and the air inside doesn't turn a lot. And because of that, there is little chance of particles settling on the product."
New direction, new opportunity
Cleanliness seems to be the name of the game, according to Ken Baker, AdvantaPure's, chief executive of the NewAge Industries division.
The renovation aims at providing AdvantaPure with a stronger foothold on the "clean-pure product" market.
"Key emphasis is placed on cleanliness, validations and reliable delivery of products," Baker says.
"The clean/pure products are where we are looking to grow," adds Warner. "Our new division, AdvantaPure, and its business plan were developed to forge into this new direction. It is our future."
The original ISO Class 8 facility was completed in May 2000, while the four-month-long renovation was completed last February.
Needling and Warner declined to go into specifics on cleanroom equipment and components, but did say the manufacturing environment is outfitted with a mill, extruders, curing towers, take-up equipment and 10 HEPA filters within the HVAC system.
Tubing and hose are produced under federal current Good Manufacturing Practices (cGMPs), with special considerations for ventilation, appropriate clothing and inspections. Personnel are trained to maintain cGMPs as well. The facility also received ISO 9002 certification for its processes.
"We mix the material, extrude it and then package it in a clean environment," Needling says.
The positively pressurized cleanroom is fed with 100 percent re-circulated HEPA-filtered air and maintained at a temperature of 68 degrees Fahrenheit, with a relative humidity of 30 to 40 percent.
"In any kind of industrial environment, dust, skin particles and facial hair can fall into the hopper and be absorbed into the material used to make the tubing and hosing," Warner says. "In this room, that won't happen. The tubing has to be as pure as possible, but if it gets dirty when it's opened at say a pharmaceutical plant, it can be autoclaved or sterilized with ethylene oxide or steam."
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Clean Systems breaks ground for northern Israel facility
by Mark A. DeSorbo
NEW YORK CITY- Clean Systems Technology Group Ltd., a designer, manufacturer and installer of ultra-high-purity gas and chemical delivery systems for the microelectronics, fiber-optics, biotech and pharmaceutical industries, has broken ground on a 20,000-square-foot facility in northern Israel.
The new facility will include a 1,500-square-foot cleanroom, similar to the company's primary facility in Kiryat-Gat. The cleanroom has an ISO Class 5 area for welding and an ISO Class 6 section for assembly. It is expected to be operational this month, around the same time the Clean Systems facility in Milan, Italy, will become operational.
"As our clients' needs for ultra-high-purity systems expand, we need to have sufficient facilities to meet this growing demand," says Jacob Lustgarten, chairman and president of Clean Systems. "By building this new facility, we will be able to meet the needs of our Israeli clients located in northern Israel, especially Tower Semiconductor, which is completing its new plant in Migdal Ha'emek and in Iscar, an innovator in cutting tools."
| Key facts | |
| Size of facility: | 240,000 square feet, 2,500 of which is ISO Class 6 cleanroom space |
| Purpose of facilities: | Manufacture thermoplastic and thermoset tubing and hosing for the pharmaceutical, biomedical, cosmetic and food industries. |
| Cost: | $450,000 |