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Article | March 31, 2001
FDA OK's Pharmacia's aseptic system
In December, Peapack, NJ-based Pharmacia Corp. received Food and Drug Administration approval to produce its parenteral drug Caverject on an aseptic filling system that improves sterility assurance before and during vial filling, checkweighing and stoppering processes.
The barrier isolator filling system is supplied by Bosch Packaging Technology NA (Minneapolis MN). Called the MAFS® (Mini Aseptic Filling System) the equipment was originally installed at Pharmacia’s Kalamazoo MI plant in ’97 as part of the company’s Center for Advanced Sterile Technology. This is reportedly FDA’s first approval of a MAFS barrier isolator filling system in the United States.
“This is the next generation of aseptic processing technology” Arnie DeVisser tells Packaging World. DeVisser a business unit director at Pharmacia’s Kalamazoo plant adds “The technology provides an absolute barrier between product and operator during filling and freeze drying.”
The new line gives Pharmacia an alternative site for manufacture of the product which is produced at the company’s Kalamazoo facility. The MAFS system includes equipment used to wash fill checkweigh and apply closures within a cleanroom environment. At full-scale production the line can run at speeds to 400 vials/min.
Caverject a therapy used for male impotency is prescribed by medical professionals. Expected to be available this summer the injectable liquid product is filled in a 10-mL vial within a folding carton. (JB)
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