Plastics the prescription for medical market

Plastics are a key tool in pharmaceutical companies’ efforts to stop counterfeit medicine sales. The problem is deadly serious: the World Health Organization says 53% of all anti-malarial drugs in Southeast Asia are counterfeit, for example.

German medical packaging processor Wipak Walsrode (Walsrode) has come out with what it says is a forgery-proof and anti-abrasion technology based on laser coating for label films of thermoformable packs.

“Using the laser technique as a bar-coding aid may in future overtake conventional systems,” predicts Markus Koppers, a development engineer at the company. The method was previously only used for flowpack pouches. The next step sees product-related data such as EAN bar codes, best-before/use-before data, or batch numbers being applied to thermoformed pharmaceutical packs. Field trials with thermoformable PET film as the tray material and Biaxer (oriented PET with a polyolefin sealing layer) as lidding show the bar code can be applied in 400 milliseconds. Since the information is applied directly onto the film, counterfeiters cannot tamper with the product without causing the purchaser to become suspicious. Wipak researchers are working on a method of laser-aided labeling that is sandwiched between film layers, he says.

Polyester film extruder Tesa Scribos (Hamburg, Germany) has launched Tesa Holospot, a multilevel, anti-counterfeiting holographic system designed for product and packaging authentication and identification throughout the supply chain. Each of the four levels of verification offers its own degree of proof. Level one is an overt readable holographic code. Level two is a semi-covert micro image featuring color changes readable with a magnifier, while level three reveals variable shining images through a laser magnifier. At the highest level are covert, computer-encrypted security data only detected via a digital reading device.

The extruded cast PET adhesive tape permits storage of up to 1 KB/Holospot. Data and graphics are scalable and can be placed on surfaces as small as 5 mm in diameter. For security reasons Holospot is processed exclusively by Tesa Scribos in Hamburg and then laser-written holographics are applied at the company’s Heidelberg, Germany site.

The U.S. subsidiary of plastics processor Klöckner Pentaplast (Montabour, Germany) has come out with a new blister design program, Pentapharm BlisterPro, a finite-element software model for thermoforming pharmaceutical blister packs to improve film selection and security. The program allows processors to avoid expensive production-line trials and tooling costs. Thickness distribution, surface areas, barrier evaluation, and permeability estimates of thermoformed cavities are simulated via CAD. And early this year Rexam (London, England) announced it would offer pharmaceutical suppliers fully integrated Radio Frequency Identification (RFID) -tagged plastic pharmaceutical bottles that comply with FDA recommendations and offer a fully traceable lifecycle, to help prevent counterfeiting. To date, pharmaceutical companies typically have applied these tags and then tested them, but now the processor is offering to shoulder this burden.

Innovation continues for this fertile market

The medical market is proving a fertile one for processing innovation beyond just anti-counterfeiting measures, of course. Processors cite reasons including palatable profitability, and note that keeping a positive state in customer/supplier relationships is also important to the customer.

Kurt Eggmann, director of sales and project management at injection molder Weidmann (Rapperswil, Switzerland), says his firm is making headway on the next generation of its “lab on a chip” project (see November 2003 MPW). These include hundreds of 30-µm-diameter molded channels. “Demand for this is growing very quickly,” he says. His firm has added additional cleanroom capacity, and he says its goal is to show medical industry partners it can handle not only molding but also design, post-processing, and packaging, both primary and secondary.

West Pharmaceutical (Lionville, PA) in March commercially launched its new Vial2Bag adaptors able to attach to any IV bag, says Hendrik Hornsved, business development manager. The adaptors fit onto IV ports, which are the same on all bags; a spike penetrates the IV port and allows a care provider to reconstitute a powdered medicine in the IV solution, without a separate injection. The adaptor is molded of polycarbonate with a PVC butterfly valve. “The ability to mount an IV set to a powder vial is unique,” he says.

Injection molder Juno Inc. (Enoka, MN) this year announced it now offers customers an ISO Class 7 (Class 10,000) facility for multishot medical molding with SpinStack tooling developed by Gram Technology (Scottsdale, AZ). Juno is a licensee of Gram’s SpinStack moldmaking technology. “Multishot molding and SpinStack tooling can reduce part numbers and assembly steps by producing, and in effect, assembling two or more components in one mold,” said John Jenkins, Juno plant manager. “This multishot molding capability gives designers the flexibility to add features such as soft-touch finishes and molded-in gaskets and seals.”

New materials take considerable time to make headway in the heavily legislated medical market, but metal injection molder Ti-Jet (Kiel, Germany) is seeing rapid uptake for its parts, following a recent CE certification of the titanium it processes as well as its process. Karl-Heinz Otto, managing director of parent firm Tricumed, says, “If it’s a complex part, then MIM is almost always a more cost-effective process (compared to metal processing methods)…The challenge is getting the developers to know what can be done.” At the Medtec show in Stuttgart, Germany in late February, he showed MPW parts now all entering commercial use. (Medtec is organized by MPW publisher Canon Communications LLC). One recent application Otto believes may be novel is a large (by MIM standards—it’s circular with a ca. 3-cm radius) part for a medical pump. Novel is that the MIM part is processed on a hot runner–equipped mold. The pump entered the market this spring. Otto says Ti-Jet, which already has a global customer base, now is offering licenses to other processors for its materials and process.