Baxter Labs helps develop validatable pouch sealers (sidebar)

Materials also a variable

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Baxter Healthcare CVG packs its medical devices into both lidded trays and into flexible pouches. Tray materials are often fabricated from calendared Barex from BP Chemicals (Naperville, IL), Eastar™ PETG copolyester from Eastman Chemical (Kingsport, TN) or polycarbonate, says Jim Sparks, senior packaging engineer. Lidding for these trays is usually Tyvek™ from DuPont (Wilmington, DE).

“Depending on the performance we need,” says Sparks (left), “we’ll use either coated or uncoated Tyvek on our pouches. The material on the other side will be a plastic film or laminate, often using polyesters or nylon if we need puncture resistance.”

The variety of materials used increases the validation burden, Sparks says. And it’s not just the materials themselves. “When you get into pouch sealers, even the size of the pouch can make a difference. We run some as narrow as just two inches wide, but others are up to 18 inches wide. You’ll have differing seal parameters for those sizes, even if they are made of the same materials. So validation is not just material-specific, sometimes it’s also size-specific.”

Pouch style can play a role too, adds Mark Goldman of Packaging Aids Corp. “For example, if a manufacturer shifted from a pillow-style pouch to a gussetted bag, the validation process would have to be redone. That’s because the gusset-style would require seals through multiple layers of materials.”

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