DANBURY, Conn., Sept. 18, 2013 (GLOBE NEWSWIRE) -- ATMI, Inc. (Nasdaq:ATMI), a global technology company and leader in single-use bioprocess solutions, has introduced a line of pyrogen-free vials in collaboration with Disposable Lab (D-Lab), a Bordeaux, France-based contract-manufacturing company. Designed to meet biopharmaceutical filling and final packaging needs, the patent-pending Pyrofree® vials are the only cost effective, ready-to-use vials guaranteed to be both pyrogen-free and sterile upon delivery.
"We have come together with D-Lab to offer this comprehensive solution in support of our customers' end goal of advancing patient health and safety," said Senior Vice President and General Manager of ATMI LifeSciences, Mario Philips. "Pyrofree vials can be incorporated into ATMI's existing ultra-clean sterile packaging and fill/finish technologies, or used independently."
Pyrogens 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. This makes it critical to ensure that pyrogens are not present in biopharmaceutical products. While difficult, the most common techniques to remove pyrogens are either inactivation or destruction of the molecule through depyrogenation.
ATMI subjects all Pyrofree vials to a thorough depyrogenation process that includes washing (with water for injection) and heating the vials to high temperatures in a polyether ether ketone (PEEK) bag to achieve a three-log reduction. Process specifications can be further modified based on customer requests.
"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," noted Jean-Pascal Zambaux, inventor of Pyrofree and majority owner of D-Lab. "The vials may also be used for commercial safety stocks of injectables, and feature sizes up to 1 liter."
Pyrofree vials are made to withstand the high temperatures during depyrogenation and sterilization. After these steps, the vials are double-vacuum-packed in a PEEK bag for tamper-evidence, as well as to maintain sterility and guarantee no external contact. 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.
Pyrofree vials are currently available for sale. You can learn more about the Pyrofree vials and technology by visiting: http://www.atmi.com/lifesciences/products/pyrofree/
ATMI Inc. provides specialty semiconductor materials, and safe, high-purity materials handling and delivery technologies designed to increase process efficiencies for the global semiconductor, flat-panel and life sciences industries. For more information, please visit http://www.atmi.com.
About ATMI LifeSciences
ATMI LifeSciences is an acknowledged technology leader in the field of single-use bioprocess systems and consumables for the pharmaceutical and biopharmaceutical industries. Its innovative, market-leading portfolio of custom-engineered, flexible packaging solutions, single-use storage systems, mixers and bioreactors is driving bioprocess efficiency and delivering value for biopharmaceutical companies around the world. For more information, please visit www.atmi-lifesciences.com.
Disposable-Lab SAS is a pharmaceutical company which develops innovative technologies based on a disposable isolator and disposable process equipment. Disposable-Lab SAS is offering the life sciences industry a new way to manufacture sterile drugs, enabling dramatic reductions in time and costs. Disposable-Lab is located in Bordeaux Montesquieu (France) where it also serves as a contract manufacturing organization (CMO). It is the first pharmaceutical facility featuring only disposable equipment, including a single-use isolator for sterile manufacturing of liquid and freeze-dried products, that is scalable up to 200L.
ATMI and the ATMI logo are trademarks or registered trademark of Advanced Technology Materials, Inc. in the U.S., other countries, or both. Pyrofree is a registered trademark of Disposable-Lab SAS.
Statements contained herein that relate to ATMI's future performance, including, without limitation, statements with respect to ATMI's anticipated results of operations or level of business for 2013 or any other future period, are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on current expectations only and are subject to certain risks, uncertainties and assumptions, including, but not limited to, changes in semiconductor and life sciences industry growth (including, without limitation, wafer starts) or ATMI's markets; competition, problems or delays developing, commercializing and delivering new products; customer-driven pricing pressure; potential loss of key customers; problems or delays in integrating acquired operations and businesses; uncertainty in the credit and financial markets; ability to protect ATMI's proprietary technology; and other factors described in ATMI's Form 10-K for the year ended December 31, 2012 and other subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties may cause actual results to differ materially from those expressed in our forward-looking statements. ATMI undertakes no obligation to update any forward-looking statements.