ENTEGRIS, Inc. announced today its new Aramus™ 2D bag assembly for single-use bioprocessing applications. Available in 500-ml, 1-liter and 2-liter sizes, Aramus assemblies use ultrapure, advanced film technology that is comprised of one fluoropolymer, gamma-stable film in a single layer. The new film provides an increased level of security and protection from particles and eliminates many of the common extractables from traditional single-use bags that can leach into bioprocessing fluids. The new bag – along with associated clamps, tubing and fittings that complete the assembly – represents the first of a future suite of single-use products that ENTEGRIS will offer under the Aramus brand.
“ENTEGRIS has a long history of providing advanced, polymer-based technologies for leading-edge processes that have stringent quality standards and contamination controls. This served us well in developing a single, strong bioprocessing film that maintains gamma stability,” noted ENTEGRIS Director of Life Sciences, Eric Isberg. “Our new Aramus bag assembly leverages that history and expertise, and provides a new level of purity and protection for final filling with the flexibility for use in a wide variety of other bioprocessing applications.”
Advanced bioprocessing applications rely heavily today on single-use technologies to effectively meet cost and batch-size requirements in bioprocessing. Critical challenges for bags, or vessels, involve protecting and maintaining the purity of bioprocess materials housed in the vessels, as well as the integrity of the vessels themselves to withstand a variety of temperatures and uses, handling and transportation. The Aramus bag incorporates an innovative film that consists of a high-grade, gamma-stable and durable fluoropolymer material in one layer. Using a single layer avoids the requirement of adhesives and binders commonly used in the industry to meld multiple film layers together for added protection. These adhesives and binders, along with particulates from the films, can often leach into bioprocess materials and result in contamination and failure of the high-value, processed batch. Aramus bags are free of this occurrence. The one-film/one-layer feature, along with the strength of the film, can lead to lower risk of assembly failures and higher yield.
Manufactured in an ISO Class 5 cleanroom, with materials and manufacturing methodology that go beyond the standard protocols, Aramus single-use assemblies offer universal material compatibility and allow for easier validation. Moreover, the ENTEGRIS fluoropolymer technology offers utility in a wider range of operating temperatures, including increased efficacy in frozen applications (to -85°C) to reduce the risk of assembly breakage.