By Ulf Danielsson
Any building project is subject to unanticipated construction delays and possible cost overrides. To manage these risks effectively, many companies have turned to modular design-build techniques where much of the work is done under optimum conditions elsewhere and assembled on-site.
The concept, marketed to the pharma/biotech industry by Pharmadule AB, a privately held Swedish firm, was initiated in the 1980s by an early founding engineer facing the challenge of constructing facilities in remote areas of Asia. “He decided to build the plant in a factory close to home and then ship the whole thing and install it, instead of standing out in the snow or sandstorms of Asia,” explains Ulf Danielsson, Pharmadule’s VP of sales and marketing. Nearly 80% of any project’s work is done inside Pharmadule’s factory, which was recently moved to Estonia.
Since Pharmadule’s founding, 80% of its projects have been completed within two months of projected schedule and 50% with no variance whatsoever. As to cost, 70% were completed within 3% or less variance, and none have exceeded 10% variance. On average, its projects shave 6 to 12 months off the entire process, which, notes Danielsson, amounts to a lot of time in cases where a new pharmaceutical is scheduled to be launched.
“We hope any circumstances would prompt companies to choose modular, regardless of whether a biopharmaceutical plant needs to be built in the United States, Europe, or a remote area of Asia,” says Danielsson. The firm has built about a dozen facilities in the United States over the past decade — many of them among its largest — for a total of more than 50 worldwide.
A Modular Solution For Any Size Company
Pharmadule’s clients include multinational firms such as Eli Lilly, Merck, Baxter, Genentech, Pharmacia (now Pfizer) and AstraZeneca. It recently completed aseptic filling facilities for Merck & Co., Eli Lilly, and Baxter Pharmaceutical Solutions and API (active pharmaceutical ingredient) biotechnology facilities for Eli Lilly. The company also has projects under way in New Jersey for Schering-Plough and in North Carolina for Merck.
Pharmadule recently added a section to increase capacity at an existing AstraZeneca plant in Asia, which it delivered 10 years ago. Its off-site building technique minimized disruption to existing operations, keeping “a lot of dust and debris out of the ventilation system for two years,” notes Danielsson.
It has provided plants for all types of drug delivery forms including injectables, IV solutions, tablets and capsules, nasal drops, and topicals. Unsurprisingly, with the large number of biotech products gaining approval, the most common delivery form manufactured in these plants is liquid or freeze-dried injectables, in vials or syringes.
Manufacturing In A Workshop Environment
Members of the firm’s 150-person team of architects and engineers do early layout examples and indicate project costs, which continue to be refined pending client approval. At its factory, the interior and “envelope” (exterior) of the plants are built in a container, or what the company calls a ”module,” with a footprint of 600 square feet. Its three-dimensional steel frame is nearly four times as large in volume as an ordinary shipping container. The steel frames are outfitted with cast concrete floors and walls with pipe work, electrical wiring, and HVAC-ducting running throughout and air handling units and process equipment on the second floor. The modules are connected as the automation runs throughout, and they fit together like building blocks.
“Everything is done on assembly lines in a workshop environment, by workers who do only pharmaceutical and biotech plants,” notes Danielsson. The engineers factor in various local building codes such as California earthquake or East Coast hurricane codes. The testing of the entire plant is completed before shipment; a final qualification process is carried out at the client’s site.
Ulf Danielsson is VP of sales and marketing at Pharmadule AB (www.pharmadule.com) in Stockholm, Sweden. With more than 25 years of experience in the biotechnology and pharmaceutical industries, he interfaces with prospective clients interested in modular design-build projects. Danielsson joined Pharmadule in 1996 after holding positions with Pharmacia Biotech (now GE Healthcare Biosciences) and Pall Filtration.