Pharmaceutical Firms Opt for Local Control
By Sheila Galatowitsch
Concerned about costs, containment and safety, pharmaceutical firms are increasingly interested in cleanroom technology on a smaller scale–modular cleanrooms, isolators and minienvironments–where they can exercise “local” control. And more first-time users are implementing the technologies than ever before.
“As these companies grow, which they are all doing, they need to be able to move their cleanroom or upgrade it as their requirements change. With the modular room, they can take it down and move it easily, and they don`t have to worry about future space restrictions,” says Ellen Bona, Servicor Inc.`s international sales and marketing manager.
“The market is extremely conscious of the price of the cleanroom,” says Rudy Colombi, vice president of sales and marketing for Tanvec Inc. (Farmington Hills, MI), a project design and construction firm. “They identify modularity with a much easier and more economical type of installation.”
Modularity is also the choice of engineers at Ganes Chemicals (Pennsville, NJ), a manufacturer of bulk medicinal chemicals. The company is planning to install its first cleanrooms over the next few months within existing manufacturing areas, according to Steven Kruch, process/project engineer. The Class 100,000 cleanrooms will house new equipment and prevent cross-contamination. “Modular cleanrooms are an easy, quick way to do that, and it looks like a reasonable price,” Kruch says.
Kruch and his colleagues are also investigating isolation technology to prevent cross-contamination in other parts of the company`s manufacturing process. Because isolators maintain a sterilized or sanitized environment, interest in the technology is soaring throughout the industry.
“The market has exploded,” says Lee Francis, president of Isolation Technologies (Englewood, CO), a manufacturer of custom isolator and transfer systems. Orders for isolators started to increase at the end of last year, and now isolation vendors are “swamped,” Lee says. The majority of Isolation Technologies` pharmaceutical orders are for filling suites applications, such as liquid filling, lyophilization and sterilization, which require complex systems integration. The giant pharmaceutical companies have already adopted isolation technology, Lee says, and now smaller companies are lining up to place orders.
Lee predicts that as the technology becomes more widely accepted, many pharmaceutical users may opt for isolators instead of building Class 100 cleanrooms. “For just about any application that requires a controlled environment, we can put that process inside of isolators,” he says. New pharmaceutical manufacturing facilities will have Class 10,000 or Class 100,000 conventional cleanrooms, but isolators for Class 100 requirements. “Barrier isolation technology makes the building cheaper to build and cheaper to operate,” he says.
Sales of conventional cleanrooms may indeed suffer with the growth of isolation technology, according to Russ Krainiak, isolation containment manager for Flanders Filters (Washington, NC), and a member of the American Glovebox Society`s board of directors. “That`s one of the big reasons why Flanders is pursuing this market,” Krainiak says. Flanders delivered a barrier isolation system to Bayer last year for manufacture of a parenteral drug.
Like isolators, worker-accessible minienvironments also help meet user concerns for safety, cross-contamination and GMP compliance, says Vince Crowley of Crowley Associates (Madison, NJ), an independent consultant for the pharmaceutical industry who specializes in critical environments. Crowley says he is seeing more Class 100 to Class 10,000 minienvironments used for conveyors, accumulators, cappers and other pieces of equipment where the product is exposed. These days, “companies are loath to commit to huge construction projects,” Crowley says.
Heightened interest in locally controlled environments was evident at the pharmaceutical manufacturing trade show Interphex, held recently in New York City, where contamination control technology was spotlighted with a fully operational cleanroom set up on the show floor. Servicor Inc. (San Carlos, CA) and 10 other vendors sponsored the 12- ¥ 36-ft modular cleanroom, equipped with sticky mats, garments, wipes, curtains, floor, lights, stainless steel hoods and carts, HEPA filters and an air handling system. The cleanroom attracted many novice users asking about flexibility and price, according to Servicor`s Bona.
In another industry trend, suppliers to pharmaceutical companies are being urged to implement cleanroom technology into their own processes–paralleling a similar trend within the semiconductor industry. Crowley says he has fielded calls from almost every kind of supplier to the pharmaceutical industry. Many of these companies are planning their first cleanroom, upgrading from a “white” room to a fully classified cleanroom.
Trent Tube (East Troy, WI), which supplies tubes and pipes to both industries, is investigating cleanroom technology for production of its next-generation electropolish tubulars, according to Mark Spannknebel, vice president of sales and marketing. The tubes will be used in the semiconductor market for high purity applications and will require a Class 100 cleanroom for the final process. n