Transatlantic Partners to Produce Pyrogen-Free Containers for the Biopharmaceutical Industry

American and French manufacturers of products for the biopharmaceutical industry are teaming up to produce a line of sterile, pyrogen-free vials and containers.

A pyrogen is defined as any substance that can cause a fever. Bacterial pyrogens include endotoxins, which are poisonous substances inside the bacterial cell that are released only after destruction of the cell wall. This can happen during pharmaceutical sterilization processes that use harsh conditions such as gamma-irradiation, exposure to ethylene oxide gas, and steam sterilization.

Endotoxins can become pyrogenic when released into the bloodstream or other tissue where they are not usually found. Thus, it is critical to ensure there are no pyrogens present on the primary packaging of injectable drugs. The injection of endotoxins into the blood can cause severe hazard to a patient and in some cases, lead to septic shock.

Depyrogenation, or the removal of pyrogens, is required in the aseptic filling process of parenteral drugs. To guarantee the highest level of depyrogenated plasticware for biopharmaceutical manufacturing, ATMI, Inc. (Danbury, CT, USA), a global technology company and leader in single-use bioprocess solutions, is introducing a line of pyrogen-free vials (Pyrofree) in collaboration with the contract-manufacturing company Disposable-Lab (Martillac, France).

Pyrofree vials are made to withstand high temperatures during depyrogenation and sterilization. After these steps, the vials are double vacuum packed in a PEEK (polyether ether ketone) bag for tamper-evidence, as well as to maintain sterility and guarantee no external contact. A third 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.

"We have come together with Disposable-Lab to offer this comprehensive solution in support of our customers' end goal of advancing patient health and safety," said Mario Philips, general manager of ATMI. "Pyrofree vials can be incorporated into ATMI's existing ultra-clean sterile packaging and fill/finish technologies, or used independently."

"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," said Jean-Pascal Zambaux, majority owner of Disposable-Lab. "The vials may also be used for commercial safety stocks of injectables, and feature sizes up to one liter."

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ATMI, Inc.
Disposable-Lab