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news.Cantrell Drug Company has entered into an exclusive agreement to become the first human drug compounding outsourcing facility to utilize Aseptic Technologies’ closed vial system for aseptic filling of injectable drugs.
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Outsourcing facilities were created under the federal Drug Quality and Security Act (DQSA) enacted in November 2013.
Under the agreement, Cantrell Drug Company will prepare sterile compounded medications with Aseptic Technologies’ Crystal® Closed Vial Technology, which was designed to increase patient safety by vastly reducing the risk of contamination during the complex filling process used by sterile compounding pharmacies and outsourcing facilities.
The new technology simplifies and reduces the risk associated with the glass vial filling process used by pharmaceutical manufacturers. Additionally, it provides easier handling for pharmacists and hospital staff who dispense medication.
"This technology represents a revolutionary advance for Cantrell Drug Company, as well as for the sterile product industry in general," said Dell McCarley, Chief Executive Officer of Cantrell Drug Company. "We decided to invest in the Crystal Closed Vial Technology because of the high level of quality assurance it will offer to our customers in the hospital market and, by extension, the patients they serve."
Under the closed vial process, each vial will be assembled in a clean room and sterilized by gamma irradiation before being delivered, ready to fill, to Cantrell Drug Company. A Crystalrobotic system in a SKAN isolator fills each vial by piercing the elastic stopper with a special needle, delivering the liquid, and quickly re-sealing the opening with the zap of a laser.
Vials are covered with a specially designed cap which health care providers eventually open to withdraw the sterile medication and administer to patients.
Cantrell Drug Company regularly supplies hospitals with sterile compounded medications, some of which are commercially unavailable and others that are simple admixtures. The company is the first U.S. compounding pharmacy to partner with Aseptic Technologies, a Belgium-based business which was spun out of GSK Biologicals, a subsidiary of global pharmaceutical company GlaxoSmithKline, in 2002.
"The collaboration with Cantrell Drug Company is a real opportunity to offer the benefits of the best aseptic technology to a broad base of patients in the United States," said Aseptic Technologies CEO Patrick Balériaux.
"At Aseptic Technologies, we are very proud and excited to actively participate with Cantrell Drug Company in continuing the improvement of drug safety in hospitals thanks to our Crystal Closed Vial Technology and our versatile robotic equipment to be installed in SKAN isolators."
The Aseptic Technologies partnership continues Cantrell Drug Company’s tradition of innovation and investment to achieve the highest quality standards. Earlier this year, the company was among the first large-scale sterile compounding pharmacies in the nation to register as an outsourcing facility with the U.S. Food and Drug Administration (FDA) and follow more rigorous standards established by the DQSA. Prior to this registration, Cantrell Drug Company had voluntarily listed drug products with the FDA.
"At Cantrell, patient safety is our top priority and that’s why we are always evaluating our operations and seeking opportunities to enhance quality assurance," said Mike Pierce, President of Cantrell Drug Company. "We believe our investment in the closed vial technology takes us to another level of quality and safety, one that is unsurpassed in the sterile compounding industry."