Medical Device Link.

Originally Published PMPN December 2004

NEWS

Med-Instill’s Intact sterile vial filler will soon be marketed by GSK-Bio.

GlaxoSmithKline Biologicals (GSK-Bio; Rixensart, Belgium) has signed a major development agreement with sterilization technology company Med-Instill Inc. (Stamford, CT). Under the terms of the agreement, Med-Instill will grant exclusive rights for its Intact sterile vial filling technology to GSK-Bio until 2021. Those rights include the filling of sterile vials, prefilled syringes, and other devices in the fields of vaccines and pharmaceutical injectables.

According to published reports, GSK-Bio plans to implement this technology in its own manufacturing facilities and then offer it to the rest of the industry through its dedicated Belgian subsidiary, Aseptic Technologies. In a recent statement, Jean Stephenne, president of GSK-Bio, predicted the technology will change the manufacturing of injectable products in the pharmaceutical industry. “With the Intact stopper and its Intact filling technology, we have engineered compliance for the simplification of manufacturing procedures of injectable vials and prefilled syringes,” he said.

Med-Instill developed Intact as part of a procedure for filling sterile vials that requires no chemicals or preservatives. The technology’s closed filling system uses preassembled and sterilized glass or plastic containers that are filled through the stopper with a non-coring sterile filling needle. Because the system starts with a closed container, the interior fluid path of that container is clean and maintained sterile throughout the filling process. In this process, the only insulator needed is the closed and sterile intact vial.

Med-Instill’s Intact sterile vial filler will soon be marketed by GSK-Bio.

According to Med-Instill’s chairman, Daniel Py, MD, ScD, this replaces the industry practice of adding chemicals to destroy potential germs with a pure physical barrier that prevents contamination. “This is a multiple-dose drug container that is sterile from first to last dose,” says Py, formerly with Merck. “We want to protect liquid from any air exposure. In a plant, you have air all around, even if it’s filtered air. With this technology, the drug container itself works as an isolator.”

Py claims that using Intact results in up to 70% capital and material savings for companies, while delivering product to manufacturers at much faster speeds. He points out that the technology allows for production of a vaccine using a smaller space in more mobile situations. As a result, he says, it is reportedly quicker, easier, and cheaper than traditional methods. Glaxo, for its part, has already tested the technology and put it into production.

According to Py, the Intact system achieved a milestone in August 2003 with the successful performance qualification and microbiological validation of the entire system. That round of testing included three media fills, each with more than 10,000 vials. During this trial, no microbiologically contaminated vials were recorded, says Py. The validation of that system concluded the development and successful manufacturing of the Intact vials, resealable stoppers, and the Simplex filling and sealing machine. In addition, the validation was a protocol-based qualification written and conducted by third- party industry experts.

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