White Paper

Improving Process Quality: Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing

By Chuck Reed, Past ISPE Chairman, Packaging COP

Since its introduction into the North American pharmaceutical market more than 55 years ago, Blow-fill-seal (BFS) aseptic processing has established itself as a highly efficient and safe system for the filling and packaging of sterile pharmaceutical liquids and other healthcare products, such as creams and ointments. BFS product usage has been widely established in the ophthalmic and respiratory therapy markets for some time, and lately, BFS technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

BFS enables a container to be molded from plastic, aseptically filled, and hermetically sealed in one continuous, integrated, and automatic operation, without human manipulation. The process provides flexibility in container design and system changeovers, high-volume product output, low operational costs, and high assurance of product sterility. The inherent safety of the process – packaging sterile products under aseptic conditions without human intervention – has led the FDA, and the United States Pharmacopoeia, to characterize BFS technology as an "advanced aseptic process", indicating its use as a preferred technology.

New advances in drug delivery, the desire to improve convenience in handling pharmaceutical products, growing emphasis on combination products, the increasing focus on protein-based drugs and other biologics, and tighter regulatory criteria on product safety, have focused more attention on BFS technology over traditional aseptic methods as a better solution for the sterile, aseptic processing of pharmaceutical liquids.

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