BFS Facility Built for Biologicals
Maropack AG (www.maropack.ch) is building a facility in Switzerland to be dedicated to biological products. The U.S. FDA inspected facility will be the first to place a Bottelpack blow-fill-seal machine from sister company Rommelag into a BSL-2 environment, reports Tim Kram, general manager of Rommelag USA Inc. The first construction phase entails completing the main facility as well as the first BSL-2 filling suite. Three more modular filling suites can be added to support additional products.
“The Maropack facility gives biological product manufacturers the option to use blow-fill-seal technology,” explains Kram.
“Manufacturers of vaccines and other biological products are looking for single-dose packages, and blow-fill-seal packages offer convenience and dosing control as well as tamper evidence, minimizing the chance for counterfeiting. BFS containers feature a single contact material and are more robust than glass, minimizing breaking issues.”
Maropack’s installation will feature advanced aseptic filling capability modified to accommodate products that require low temperatures, such as 2° to 8° C. “We can bring down the product temperature prior to filling to negate any heat added to the product by the blow-fill-seal process. After filling the product can quickly be brought down to refrigerated or frozen condition. The process minimizes product exposure to temperatures above ambient conditions.”
In addition, BFS containers have been shown to be stable at low-temperature freezing, such as that for liquid nitrogen, says Kram. “Rommelag has tested temperature-sensitive biological products frozen in LDPE. Monolayer plastic containers do not experience the adverse thermal expansion conditions that containers made from multiple materials do, such as glass vials with rubber stoppers and aluminum crimped caps.”
In addition, the blow-fill-seal process offers high-capacity, low-cost production, Kram adds.
The facility will enable customers to perform stability, clinical trial, and registration runs using BFS technology.
Maropack can supply long-term contract manufacturing services, and Rommelag can provide container design and scale-up support.