BioShell Custom Designs for Single-Use Bulk Bags

With its BioShell protection system, UFP Technologies (Georgetown, MA) offers alternative technology for safeguarding biopharma single-use bags during freezing, handling, storage, and transport.

BioShell is constructed of light-weight, dual-density foam in either a hinged clamshell or a two-piece top-and-bottom design. Higher density foam on the outside provides structural integrity and puncture resistance while softer foam on the inside offers cushioning during impacts.

The system is designed to protect bags at temperatures as low as –70°C. With a glass transition temperature of –85°C, BioShell retains flexibility and cushioning properties in most low-temperature applications, says Tuna Sava, manager, BioPharm Products, UFP Technologies.

Sava says the system offers several advantages over competing solutions on the market for storing bulk ingredients that are deep frozen and thawed in later use.

BioShell is made from high-purity USP Class VI foam that is converted from rigid plastic using only nitrogen without any traditional toxic foaming agents. It contains no CFCs or HCFCs.Shipped clean-room-ready, the system is lightweight, and stackable, and nestable, which provides ease of handling, reduces shipping costs, and minimizes storage space. The units are designed for multiple use.

The BioShell units are customized to each application, whereas competitors have offered standard designs for common bag sizes, Sava says. “Each unit is created around users’ processes and requirements. We start with the bag, its fill levels, port and hose locations, freeze/thaw perimeters, and handling, storage, and shipping methods to arrive at a unique design for the system’s environment.”

Material density and wall thicknesses are varied to increase or lower the thermal conductivity of the units to adhere to freeze/thaw times required for a bag and its contents.

“Frozen ingredients stored in plastic bags need to be protected inside the plant and in shipping. Systems made of rigid plastic provide little impact absorption against a drop or accidental bumps,” Sava says.

The single-piece system follows bag contours and braces it without additional components or dunnage--reducing part numbers. Sava says the turnaround from concept to production parts can be as short as two months. “A custom-made injection-molded product would take longer and cost more to produce.”

Manufacturers are moving to plastic disposable technology for handling contents, replacing stainless-steel tanks with single-use bags. Besides being bulky and hard to store, tanks have to be cleaned and validated at each stage of filling, storage, shipping, and receiving, Sava says.

Customers of the BioShell include Genentech, Merck, Shire Pharmaceuticals, and Laureate Pharma, Sava says.