Blister Material – CFF (Alu/Alu) Structures
The History of Pharmaceutical Blister Packaging Materials – CFF (Alu/Alu) Structures
Just a little more than a decade after the launching of PTP blisters for contraceptives found the pharmaceutical industry entering a period of major growth. New Active Pharmaceutical Ingredients (APIs) under development, new Drug Delivery methods were gaining favor, all resulting in the demands for new types of packaging – one that offered the advantages of blisters (PTP) and the barrier against moisture ingress of strip packages.
Development of the Cold Formed Foil (CFF or Alu/Alu) blister began in the early 1970s at Alusuisse Aluminum Walzwerk in Singen. Like so many items in the development of pharmaceutical blister packaging, this technology began in the food sector.
A jam manufacturer was looking for a better way to package and market jams. The original development had a PVC layer of either 100 or 150 µm. Launched in the early 70s, the package had limited success.
The first major pharmaceutical application came in 1974. Alusuisse people involved in the development were Herren Gerber, Kolb, Oehlmann and Schmiletzky who worked with Bayer Italy to develop packaging for effervescent aspirin tablets. This structure was PE/Al/OPA because at that time it was sealed to conventional 30 µm foil used for strip packaging.
In 1978 Janssen in Belgium (now part of Johnson & Johnson) used the now standard structure of 60µm OPA (oriented polyamide or nylon), 45µm of aluminum and 60µm of PVC.
This structure began to gain acceptance in Europe. Glaxo accelerated that growth when in the mid 1980s they switched the packaging of Zantac® (ranitidine) from strip pack to Formpack® (Alusuisse’s trade name for the product). By this time the Alu/Alu blister offered three advantages compared with strip packaging.
- No pressure on the table as the film structure was stretched over the tablet (as happens in strip packaging)
- No direct temperature contact during sealing from all sides.
- Higher level of customer convenience or user friendliness for the consumer using the product (easier to open) as compared to strip packaging.
Glaxo’s move from strip into CFF won wide acceptance among customers. The blister (in Europe the package remained push-through) began to challenge strip packaging in moisture sensitive applications. The growth of CFF had begun.
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