The company developed and analytically tested a folding carton solution encompassing the components used to produce the final finished package. That required the selection and qualification of board materials, inks, coatings, glues, and establishing specific press protocols so that these components yielded the lowest possible levels of volatile organic compounds.
The developmental timeline for this solution has taken years with Nosco working with its suppliers to develop an advanced low migration carton system that addressed concerns in the following areas:
-Packaging-borne migrants or impurities (leachates) unidentified previously in chromatographs of analytical studies and assays, or are detected at higher levels of concentration than previously identified, indicating something has “changed.”
-Migrants affecting the pH level of the drug solution taking it out of specification
-Migrants that cause colors or discoloration.
“Nosco is seeing a growing need for low migration packaging solutions for sensitive products such as parenteral drugs, opthamalic solutions, nasal sprays, and transdermal ointments. Historically, the focus has been on the pressure-sensitive label as it is in immediate contact with the host container. More recently, attention has grown to include the outer packaging such as the folding carton. In addition to labels, we can now offer a solution that will encompass the folding carton, the label, and other packaging media,” says Kregg Albrecht, vp of solutions engineering.
“Nosco developed a systematic approach to test various components and production processes to identify, eliminate, or reduce unwanted volatile and semi-volatile compounds that might potentially permeate the packaging materials and diffuse into drug products. This enables Nosco to engineer low migration package solutions for the drug industry. The analytical methodology includes various tests to screen for out-gassing compounds, extractables, odor, and pH, says Greg Davis, low migration packaging product leader.
The complete low migration packaging solution addresses the unique needs for manufacturers and packagers of sensitive drug products. Pharmaceutical companies can apply Nosco-developed solutions to address their need for sourcing the best possible packaging components for ensuring drug product safety.
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