Patient Compliance Packaging Q&A
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Asked August 12th, 2009
When first dealing with CFB, or cold-formed blister, it is imperative you work with an experienced contract packager and with an experienced tooling supplier. Cold forming a blister entails forming the cavity without heat by using reinforced aluminum foil to provide for the stretching of the foil during the forming process. Cold forming is the ultimate blister barrier for light, moisture, and gas. The moisture-vapor transmission rate is zero. Because forming the blister is a process in which the foil is shaped and stretched to the required size, this process requires that the cavity be oversized.
There are some additional process requirements associated with cold forming:
· The product must utilize a dedicated feeder. A dedicated feeder such as a SimTap or Aylward model would accomplish this for one tablet/capsule per cavity.
· The sealing temperatures tend to be higher for a thermoformer due to the overall thickness of the materials being sealed together.
· The thermoformer must have pinhole detection to ensure that fissures do not form in the foil during the forming process.
· The blister card must have an adequate seal area around the outside of the card (minimum 4 mm) to ensure that the barrier properties at the seal are good. The only paths for moisture in this package are the seal area and any fissures in the cavities themselves.
The typical structure for lidding used for cold forming is the same as with PVC. The PE layer is adjacent to the product, and the lacquer is to the outside to provide for printing onto the foil. The typical structure of the formable foil will be PVC (product side)/Alu/OPA. The OPA helps strength the formable foil. The 0.04-mm foil does not provide sufficient structure for forming a cold-formed blister.
The alternative to cold forming is pouching if your desire is to use 0.04-mm foil. This process was used in the past successfully, but it offers little protection for the product if it is sensitive to handling, e.g., if it is a soft tablet.



