We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
LGC Clinical Diagnostics

Download Mobile App




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

By LabMedica International staff writers
Posted on 30 Sep 2013
Print article
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

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Specimen Collection & Transport
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
Gold Member
Real-time PCR System
GentierX3 Series

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria (Photo courtesy of Roche)

First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety

Malaria, a serious illness that often leads to death, is spread by a specific mosquito species that infect humans with a parasite. Other transmission modes include blood transfusions, organ transplants,... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The medical office procedure detects the key biomarker in Parkinson’s and related neurodegenerative diseases (Photo courtesy of BIDMC)

Simple Skin Biopsy Test Detects Parkinson’s and Related Neurodegenerative Diseases

Parkinson's disease and a group of related neurodegenerative disorders known as synucleinopathies impact millions globally. These conditions, including Parkinson’s disease (PD), dementia with Lewy bodies... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.