Incorporating a "locking" device which took two years to develop, the PharmaPak SHR ("Small Hands Resistant") carton is made from a specially developed, highly tear, moisture and abrasion-resistant Stora Enso cartonboard, CKB Pharma TR.
Stora Enso says recent US figures suggest up to 30% of all child poisonings reported annually there result from young children accessing grandparents' drugs – either from open packs or when medicines have been "decanted" into other "less appropriate" containers. Ismo Saarinen, Pharmaceutical Solutions director, Stora Enso Packaging Boards, New Business Innovations explained that the aim was thus to produce a highly secure pack which would resist opening by even the most determined young children, yet which even the severely arthritic could access.
"The universal non-compliance problem is a major challenge in pharmaceutical packaging," adds Saarinen. "In the US alone 125,000 lives are reportedly lost every year due to non-compliance. Our solutions can be applied to creative patient guidance schemes, which contribute to optimal compliance. The recloseable carton also responds to the highest requirements in child resistance while being very easy for senior adults to use."
The "both-hands opening system" is based on a "push, hold and pull" locking device. The user gently pushes the drawer insert inwards before simultaneously squeezing and holding two small circular apertures incorporated in the pack sides to "unlock" the pack. The drawer can then be easily removed. "The pack is designed to be senior-friendly yet, thanks to the dimensions, it would be extremely difficult for a child to get its small hands around both carton sides simultaneously and unlock the drawer," Saarinen explained.
As PharmaPak SHR is classified as a recloseable pack, no special CR closures or features are required for blisters or other inserts. The pack meets ISO 8317 child-resistance requirements, while in America child-resistance tests are currently "in progress", with the highest f=1 rating (signifying no successful attempts at access) and final approval pending.
Under a "global strategic alliance" Stora Enso will supply the tear-resistant board, while Bosch will perfect and market a complete, modular machinery system for pack manufacture, insertion of unit dose blisters, ampoules, vials or syringes, and carton assembly and sealing. Key target customers will include pharmaceutical manufacturers, clinical trails companies and contract packers. Bosch hopes to perfect the equipment's development by early next year, with a full scale-launch anticipated for the second quarter of 2005.
Designed particularly for highly toxic medicines like cardiac drugs, anti-depressants, iron preparations and diabetes treatments, PharmaPak SHR cartons will initially be available in two main versions – one for general pharmaceutical use and one for trials. Each carton will be produced from two flat, unglued carton blanks.
Bosch says a special "stabilising beam construction" makes the opening end of the pack tamper-proof, while hot air/bar sealing of the outer edge "guarantees" secure sealing. For blister packs, the carton configuration can be based on standard aluminium or plastic blister cards, with or without cartonboard foldover cards.
Bosch will manufacture each twin balcony-style line to customer requirements, while Stora plans licensing the system "concept" on a royalty basis. Robert Bosch product manager, Packaging Technology, Helmut Deichert elaborates: "A typical line will comprise a carton manufacturing module which can be combined with a semi- or fully automatic blister infeed and carton assembly module. Flat, unglued carton blanks are converted via a specific forming and welding process. Our target is to have the first generation of packaging machines available within the first half of 2005 and complete packaging lines shortly afterwards. Both intermittent and continuous motion carton forming units machines will be available."
The carton's development was undertaken mainly at Stora Enso's "Innocentres" at Karlstad, Sweden and Karhula in Finland, while its Imatra plant in Finland undertook print trials, die cutting and runnability testing. Saarinen adds: "Valuable input was provided throughout, particularly as regards potential design weak points, by Berkshire-based testing laboratory Burford Research Consultants. Burford also undertook testing to ensure the carton met the child-resistance criteria of the ISO8317 standard using panels of young and tested it for accessibility with a sample of 100 adults aged 50-70. Burford is currently the only UK test laboratory able to test to this ISO standard."
