Local delamination in pharmaceutical blister packages – A thermomechanical theory on buckling of heat-sealed composite laminates in flexible packaging

Pharmaceutical blister packages consist of cavities made from a thick polymeric form foil and a thin aluminum lid foil. Heat-sealing technology is usually used to bond the lid foil to the form foil. Occasionally, the sealed area shows buckling defects of the lid foil, which allow contamination to enter into the cavity. A contaminated product is a worst-case scenario for pharmaceutical production and must be avoided. We discuss a thermomechanical theory on buckling defects in blister packages and derive strategies to avoid these. The theory is based on the assumption that the seal of a blister packaging behaves like a laminate of thin composite layers under compressive load. Literature research on buckling of thin laminated films, thermal behavior of polymers, and seal strength of heat-sealed polymers provides the technical and physical background to elaborate the theory. The theory comprises three elements: an initial condition regarding thermal load and precedent defects; a buckling condition; and a crack propagation condition. The plausibility of the theory is verified using model calculations and heat-seal tests. The paper concludes with strategies against buckling of heat-sealed lid foils and an outlook on other applications in laminating and coating of polymer films.