As the single-source three-day event for pharmaceutical and biotech professionals unveiled this week at Jacob Javits Center in New York City, the talk quickly turned to single-use systems—from seminars held on the subject, to companies launching single-use products, such as Entegris.
The publicly funded biotechnology company recognized as a leader in contamination control launched its newest product at a press luncheon during Day 2 of Interphex— the Aramus Single-Use 2D Bag Assemblies.
As single-use systems continue becoming increasingly popular methods of pharmaceutical and biologics production, more people are jumping on the bandwagon to use them to better their products. Single-use systems differ from traditional biopharma process systems in that they are disposed of after one use as opposed to being cleaned or CIP’d (clean-in-place).
What makes these bags unique is that they’re made of a high-grade, gamma-stable fluoropolymer material in one layer, providing higher purity, greater compatibility and increased safety for critical process fluids, according to the Connecticut-based company. Most existing solutions are made from various materials and are built by fusing two or more layers of film together. As a result, a variety of additives are needed to hold the layers together, such as adhesives. These materials can often leak into process fluids in the bag, causing contamination. Since Entegris’ goal is to reduce this threat as much as possible, the company decided to opt for a single film and layer for bags.
“We think we revolutionized single-use here, it will increase single-use in the pharma industry,” said Eric Isberg, director, Life Sciences at Entegris, during his speech at the luncheon. “These materials have never been used in single-use products before, it’s a game-changer in gamma stability.”
Previous issues with current systems and contaminations prompted the 50-year-old company to come up with something new to meet its customer needs. Since the life sciences company already makes several products used in bioprocess applications, improving on what it already had in bioprocessing was the next step.
“Polymers show up in tests. In this product, there’s no risk of that since it’s a single layer, so there’s no delamination,” said Michael Johnson, business development engineering manager at Entegris during the luncheon. “Fluoropolymer material has no additive.”
The new single-use 2D bag assemblies can be used for:
- Frozen food storage
- Downstream bioprocessing
- Final fill
- Process sampling and archiving
The assemblies are said to offer the widest operating temperature range, making them more durable in frozen applications (to -85 degrees Celsius or lower).
Following suit, German life-science company Millipore Sigma has also launched three single-use products during Interphex, including a 1000-liter bioreactor, which use the company demonstrated at its booth in front of a small audience.
Stay tuned for more Interphex coverage.
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