Features | Partner Sites | Information | LinkXpress
Sign In
GLOBETECH PUBLISHING LLC
GLOBETECH MEDIA
GLOBETECH PUBLISHING LLC

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


WATERS CORPORATION

Channels

Genomics/Proteomics

view channel
Image: Outer membrane vesicles released by Bacteroides thetaiotaomicron may help initiate inflammatory bowel disease (Photo courtesy of Wandy Beatty, Washington University School of Medicine).

Interaction of Gut Cells with Bacterial Outer Membrane Vesicles Triggers Inflammatory Bowel Disease in Mouse Model

Interaction of bacterial outer membrane vesicles (OMVs) harboring sulfatase activity with the cells lining the gut has been implicated as a key step in the development of inflammatory bowel diseases (IBDs)... Read more

Drug Discovery

view channel
Image: Molecular model of the anti-cancer drug 5-fluorouracil (Photo courtesy of Wikimedia Commons).

Novel Microcapsule Approach Reduces Toxic Side Effects of Chemotherapy

Cancer researchers have reduced chemotherapy's toxic side effects by using nanoporous capsules to transport an enzyme to the site of a tumor where it is activated by a selective heating process to convert... Read more

Business

view channel

NanoString and MD Anderson Collaborate on Development of Novel Multi-Omic Expression Profiling Assays for Cancer

The University of Texas MD Anderson Cancer Center (Houston, TX, USA) and NanoString Technologies, Inc. (Seattle, WA, USA) will partner on development of a revolutionary new type of assay—simultaneously profiling gene and protein expression, initially aiming to discover and validate biomarker signatures for immuno-oncology... Read more
 

Events

02 Jun 2015 - 03 Jun 2015
15 Jun 2015 - 18 Jun 2015
Copyright © 2000-2015 Globetech Media. All rights reserved.