Blister Materials – ACLAR (PCTFE) Structures
The History of Pharmaceutical Blister Packaging Materials – ACLAR (PCTFE) Structures
Allied Chemical (now Honeywell) began development of PCTFE film in the early 1960s. An application for the trademark was made on June 19, 1961, and granted on March 27, 1962. The trademark application notes that ACLAR® is a fluorine-containing plastic in sheet or film form. The first use was August 11, 1960.
The polymer was extruded in Pottsville, PA, and the search for applications, markets and products began. Early applications included films used to protecting phosphors used in LEDs (prior to those phosphors being encapsulated), various military and aerospace applications, and the lamination of the film to other base films to improve moisture barrier. By the early 1970s laminating ACLAR® (the trade name for PCTFE film) to PVC for use in pharmaceutical blister packaging became the most important market.
Sometime after the initial launch of contraceptives in blister package the need for additional moisture barrier became clear. What is still not clear is which pharmaceutical companies initiated the search. Some suggest Hoffman La Roche in Nutley, others suggest Eli Lilly, others Ciba. Eventually this search resulted in the initial attempts to laminate Aclar® film (probably 33C) to PVC for use in blister packaging.
Tenneco experimented with laminating ACLAR® film in-line on a calender. This highlighted two problems: finding an adhesive to bond the ACLAR® to the PVC and a process that could be tightly controlled to maintain very high yields – critical given the high price of ACLAR® film. Tenneco concluded that in-line laminate could not work and that lamination had the best chance. Tenneco proceeded to purchase coating and laminating equipment and sold ACLAR® structures to the pharmaceutical marketplace.
Another place were lamination work was done at Standard Packaging Corporation (SPC) in Clifton, NJ. Tom Tang was Vice President of R&D at SPC at that time. Tom Tang had joined Standard in 1949, taking over the R&D area while still doing his PhD dissertation.
Getting adhesion between ACLAR® films and PVC or PE became on ongoing theme in the development of ACLAR® structures. The fog of history leaves us with wisps and whispers: of special formulas developed by converters, of Allied Chemical’s role in the adhesive and primer system (see below the comments on KH-1), etc. While the actual technical difficulty in laminating PVC to ACLAR® today seems somewhat overplayed, looking back through that fog there was a perception, a persistent thread at the time, that there was proprietary and complex technology involved in getting a good laminate structure.
Part of this was the on-going development for an adhesive system to bond Aclar to PVC by SPC because they saw the potential for a new market. Many of those involved in this development eventually left SPC and moved on to new companies developing coatings and laminations. These people continued the development of the Aclar/PVC lamination structures as it began to spread through the pharmaceutical industry.
A group of 5 employees left Standard Packaging Corporation (SPC) and started a new company called Tri-Pi Corporation. This company was focused on specilty laminations of Aclar to PVC Sheet and other polyethylene structures. While Tri-Pi did not last for long in the marketplace, the five founders all continued to develop Aclar® structures in the companies they joined after Tri-Pi
- Jim Coyle: who went to SHPC after Tri-Pi
- Joe Vercouteruan: who developed an adhesive that worked and became known as “Belgian Water” after Joe’s country of origin. Joe joined Tenneco after Tri-Pi.
- Carl Mazzone worked in production at SPC. Carl worked with the adhesives for both bonding Aclar® to the PE and the PE to the PVC in what became the tri-plex lamination at Tekni-Plex. Carl joined Tom Tang at Tekni-Plex after Tri-Pi.
Ray Kouts who went to Tenneco.
- Tom Tang who left Tri-Pi to found Tekni-Plex division. Carl Masoni joined him to assist in the adhesive technology of the laminations.
As the problems of the adhesive systems became sorted out technically, the tri-layer structure (PVC/PE/Aclar®), developed to work with the Allied Chemical co-polymer grades, became the standard structure. Tri-Pi experienced problems with the original supplier of key components of the adhesive used in their work. When the original adhesive was no longer available, Tri-Pi was not sustainable as a going concern.
This left the two material suppliers continued to drive the growth of Aclar®: Tenneco and their Mirrex 1025 product and Allied Chemical with the 33C and 22A co-polymer films products. There were various members of Specialty Films at Allied Chemical who assisted these developments first with Tri-Pi, then Gravure Flex and Tekni-Plex. The Allied Chemical team is listed in alphabetical order.
- Ken Haberman: Extensive work in primer coatings used in the adhesive lamination process, including the KH-1 primer system.
- Don Hartmann:
- Leo Peschinski:
- Jack Tonrey: After working extensively with pharmaceutical companies, eventually left Allied and joined Gravure Flex.
- George Troyon:
Aclar® laminations then went to companies that had other products to sustain them as Aclar® laminate volumes grew slowly: Gravure Flex and Tekni-Plex.
Sam Goldman’s Gravure Flex added the ACLAR® structures to a large food packaging business from their plant in South Hackensack, NJ. Gravure Flex had difficulties with the EPA due to leeching into holding tanks and eventually folded.
Tom Tang’s Tekni-Plex also sold products into both markets but with the collapse of Gravure Flex became the primary supplier of Aclar® laminates to the pharmaceutical packaging industry. Tenneco later sold their coating / lamination equipment, since it interfered with the sales of the base PVC to customers in the coating / lamination business.
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