ATMI, D-Lab launch new Sterile Pyrofree vials
US-based technology firm ATMI in partnership with Disposable Lab (D-Lab), a French contract-manufacturing company, has launched a line of pyrogen-free vials in order to meet biopharmaceutical filling and final packaging needs.
According to ATMI, the patent-pending Pyrofree vials are the only cost effective, ready-to-use vials guaranteed to be both pyrogen-free and sterile upon delivery.
ATMI LifeSciences senior vice president and general manager Mario Philips said the company has collaborated with D-Lab to provide the solution to support its customers' end goal of advancing patient health and safety.
"Pyrofree vials can be incorporated into ATMI's existing ultra-clean sterile packaging and fill/finish technologies, or used independently," Philips said.
Pyrogens should not be present in biopharmaceutical products, as they are a substance that induce rapid onset of fever with the potential to cause sepsis or progressive septic shock if they enter a patient's bloodstream.
ATMI employs a depyrogenation process that includes washing and heating the vials to high temperatures in a polyether ether ketone (PEEK) bag to achieve a three-log reduction to ensure that all vials are Pyrofree.
The vials are later double-vacuum-packed in a PEEK bag for tamper-evidence, as well as to maintain sterility and guarantee no external contact.
Finally, a third PE/PA film layer is added to the packaging under vacuum in a Class C cleanroom to protect the vials from any breakage during transportation and eliminate the need for a support tray.
D-Lab inventor of Pyrofree Jean-Pascal Zambaux said the vials may also be used for commercial safety stocks of injectables, and feature sizes up to 1L.
"Pyrofree brings several clear benefits including the most cost-effective solution on the market, scalability from small to commercial-scale batches, and availability in both molded and tubular formats," Zambaux said.