Closure Fights Counterfeiting

Once the vial caps have been opened, they cannot be resealed, giving the contents added security.

A new pharmaceutical injectable closure reportedly debuts as the first independently verified anti-counterfeit, tamper-evident one of its kind. Secure Packaging Systems Inc. (SPS, Cupertino, CA) em­ploys electron beam radiation to create vial caps with an extremely tight seal that carry identification tags through, and cannot become dislodged under, the pressure of heat.

The high-density polyethylene (HDPE) closures mount on glass or polymer vials in one step within a sterile environment, which the company claims is unique to its product. The heat tolerance of the caps allows them to be exposed to temperatures above melting, with­out damage, during extended autoclaving. Be­cause any at­tempt to open the cap will fracture or change it to an unusable shape, the closure provides additional prevention against tampering and counterfeiting.

Bertrand Teplitxky, SPS chairman and CEO, and Larry Martinelli, president and CEO of Heritage Technologies worked together to create and patent the closure. “I spent 10 years thinking like a crook,” Martinelli says of the development phase. “We took one old vial and held a hair dryer over the cap. It only took about a minute for it to come off.”

Martinelli and Teplitxky used radiation to create a mem­ory effect on the caps. The memory effect occurs when polyethylene is heated by radiation to nearly gelling, is stretched, and is cooled down under stress; when reheated, the material will not expand or lose shape.

Scientists at Kent State University tested temperature influences on the memory effect of such heat-shrinkable products used by SPS. After measuring the internal diameter, the external diameter, and the height of molded HDPE and molded and electron-irradiated HDPE, the caps were heated, cooled, and measured again. The nonirradiated caps lost their shape, while the radiated caps re­tained their original measurements.

Although that process renders the cap highly tamper resistant, it primarily serves as a vehicle for other tracking features in SPS’s line. The caps complement anti-counterfeit products such as SPS’s RFID pedigree-authentication polymer cap and binary optically encoded 3-D laser-read hologram la­bels. Such labels can verify authentication, purity, and concentration of medication within a 40-ppm sensitivity range, according to the manufacturer.

Vials will still need diaphragms as part of the closure. By using HDPE and avoiding aluminum seals, however, capping and filling can occur in the same cleanroom environment without risk of aluminum oxide contamination. Martinelli says this will “move the final capping operation back into the cleanroom, where it has always belonged.” Other than this, he claims there is little burden on equipment updating.

The caps can either be placed in a mid-seal position to allow for the lyophilization process, or installed in a single-operation, high-speed, direct snap-on application. Additionally, the polymer cap accommodates several vial materials such as HDPE, glass, polyester, polycarbonate, and high-density polypropylene.

Martinelli adds that pilot testing and FDA qualification programs are actively under way at several pharmaceutical companies with initial production quantities already shipped.

Industry veteran Ralph Dillon, managing director of consulting group Compliance Surety Associates, assisted with commercialization of the closures. He says that many manufacturers have attempted to create a polymer alternative to aluminum vial seals. “This has been kind of the holy grail,” he says.