Entegris Introduces Gamma-Stable Single-Use Bags

May 4, 2016
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

Typical single-use bags and materials cannot withstand a large range of temperatures. Many of the items on the market are associated with extractables that can leach into bioprocessing fluids-an issue that has recently been a topic of conversation among groups that seek to standardize single-use systems, such as the BioPhorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA).

Typical single-use bags and materials cannot withstand a large range of temperatures. Many of the items on the market are associated with extractables that can leach into bioprocessing fluids-an issue that has recently been a topic of conversation among groups that seek to standardize single-use systems, such as the BioPhorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA).

Entegris said during a presentation at INTERPHEX 2016 that with the help of its new one-layer film made of gamma-stable fluoropolymer material, many of the concerns related to bag integrity and potential leachables can be eliminated. Because the company’s Aramus bag is one layer, it does not use the adhesives and binders commonly required to fuse multiple bag layers together. In addition, the bags can be used in cryogenics without the worry of system or assembly breakage.

The new bags will be especially useful in downstream applications, said Eric Isberg, director of life sciences at Entegris. They are best suited in bioprocessing for the frozen storage of bulk drug product or for the preparation of stem-cell therapies, such as the incubation of stem cells or the frozen storage of bulk stem cells. Isberg noted that the single-use products that currently exist for these “frozen” applications don’t have comparable product purity.

The majority of fluoropolymers are not gamma stable, noted Isberg, but the Aramus bags are unique in that they are a gamma-stable option. When compared with standard polyethylene bags, the haze is reduced in the Aramus bags, so there is a much clearer vision of the product inside of the bag, the company said. Although the fluoropolymer material itself is not new-Isberg said that the material is already used in some of the wires in the aerospace industry and in “outdoor environments” where UV stability is a requirement-it is the first time the material is being used in bioprocessing. The company is pursuing intellectual property protection for this particular application of the material; the company already owns some intellectual property on coating technologies related to the stem-cell market.

The accessories and connectors associated with the Aramus 2D bags are customizable, and by next year, the bags will be commercially available in various sizes. According to a company release, the new bag “provides a new level of purity and protection for final filling with the flexibility for use in a wide variety of other bioprocessing applications.” The company also said the bags will revolutionize the single-use industry and “bring single-use into the final downstream area” of bioprocessing.

Source: Entegris