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)
