Features | Partner Sites | Information | LinkXpress
Sign In
GLOBETECH PUBLISHING LLC
GLOBETECH PUBLISHING LLC
PZ HTL SA

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

By BiotechDaily International staff writers
Posted on 30 Sep 2013
Image: Triple-vacuum-packed Pyrofree vials (Photo courtesy of ATMI, Inc.).
Image: Triple-vacuum-packed Pyrofree vials (Photo courtesy of ATMI, Inc.).
Image: Cross section view of triple-packed Pyrofree vials vials (Photo courtesy of ATMI, Inc.).
Image: Cross section view of triple-packed Pyrofree vials vials (Photo courtesy of ATMI, Inc.).
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."

Related Links:
ATMI, Inc.
Disposable-Lab


comments powered by Disqus

Channels

Genomics/Proteomics

view channel
Image: This novel, flexible film that can react to light is a promising step toward an artificial retina (Photo courtesy of the American Chemical Society).

Novel Nanofilm May Be Artificial Retina Precursor

Researchers have used advanced nanotechnology techniques to develop a light-sensitive film that has potential for future artificial retina applications. Investigators at the Hebrew University of Jerusalem... Read more

Drug Discovery

view channel
Image: The new peptide offers a triple hormone effect in a single-cell molecule (Photo courtesy of Indiana University).

Tripeptide Drug Effectively Controls Metabolic Syndrome in Rodent Model

Promising results in reducing obesity and normalizing glucose metabolism obtained with a synthetic dipeptide drug have been enhanced by the addition of a molecule of a third hormone, glucagon.... Read more

Biochemistry

view channel

Blocking Enzyme Switch Turns Off Tumor Growth in T-Cell Acute Lymphoblastic Leukemia

Researchers recently reported that blocking the action of an enzyme “switch” needed to activate tumor growth is emerging as a practical strategy for treating T-cell acute lymphoblastic leukemia. An estimated 25% of the 500 US adolescents and young adults diagnosed yearly with this aggressive disease fail to respond to... Read more

Business

view channel

R&D Partnership Initiated to Reduce Development Time for New Drugs

nanoPET Pharma, GmbH (Berlin, Germany) signed an open-ended framework contract with the international pharmaceutical company Boehringer Ingelheim (Ridgefield, CT, USA). By developing customized contrast agents for research in both basic and preclinical studies, nanoPET Pharma will contribute to the enhancement of Boehringer... Read more
 
Copyright © 2000-2014 Globetech Media. All rights reserved.