In biopharmaceutical production, each instance where materials or products in development must be stored, handled, or transported presents a risk for breakage, contamination, and expensive product loss. In a modern, decentralized biopharmaceutical production line, materials and products must be kept frozen to ensure product safety, consistency, and shelf life. Because of these new realities, we face more production costs, logistics, speed, and complexity.

Bioproduction today has dramatically increased the value of product in each container. Production processes have been contracted out or may be taking place in different parts of the country or globe. At colder temperatures, containers have considerable limitations; traditional storage bottles are often more brittle at cold temperatures and can break easily, do not pack into containers or store in freezers efficiently and take longer to freeze and thaw due to their shape and volume. 

Entegris is in a unique position to help overcome these cold temperature challenges by offering assemblies designed for extreme cold and by partnering with qualified equipment manufacturers specializing in reliable, cold-chain containment. Let us help you gain control over your processes and reduce the potentially enormous financial risk to your valuable products. 


Made from high-quality stainless steel and heavy-duty plastic material, the freezing shells provide greater bulk drug substance (BDS) protection during handling, more consistent freezing/thawing, and reduced storage density.

Entegris solutions allow you to protect and store your high-value process solutions with reduced risk of product loss, contamination, and compromised quality. Expanding our portfolio further, we offer LN2 (liquid nitrogen) cassettes for use with Aramus™ single-use bag assemblies.

The utilization of single-use (SU) systems continues to grow, and so do the purity concerns of the SU components and their potential impact on high-value final products. From the high cost of product loss due to assembly failures at fill/finish, to the ever-increasing scrutiny from regulatory bodies, every angle requires protective measures. Now, Entegris brings a new level of assurance to your process. The Aramus™ single-use 2D bags are made of a high-grade, gamma-stable fluoropolymer, providing higher purity, greater compatibility, and increased safety for critical process fluids and final products.

Two of the most significant benefits to single-use bioprocessing over reusable manufacturing equipment are lower cost and simpler operation. And yet some processing steps, such as mixing, have not been able to realize these benefits. The Entegris mixing system is designed to maximize simplicity, ease-of-use, and affordability.

The Entegris microcarrier separation system is designed to ease the finance and complexity burdens of single-use systems while maximizing simplicity, ease of use, and affordability. This system facilitates a separation process through the use of a streamlined, single-use filter/mesh bag system and peristaltic pump; no other equipment is required.

Bringing the benefits of ultimate customization, fast design, and delivery to cell culture applications, Entegris offers the motion bioreactor bag.

What does “custom” mean for bioprocessing companies? Many system suppliers advertise their capability in customization but in reality, limit it to the interchange of components or lengths of tubing. This is helpful, but falls short of what many end users are looking for. With single-use systems, Entegris offers true customization to meet your exact process needs, fast.


Entegris, Inc.

129 Concord Road

Billerica, MA 01821


Phone: 978 436 6500

Fax: 978 436 6735

Contact: Barry Westfall


  • Cleanliness of parts or enclosures is important to avoid the presence of particulate contamination that can be detrimental to quality or performance. An accepted approach to determine cleanliness is the use of liquid particle counters to quantify size and count of particles in water after exposure to the part of interest. This application note explains the use of the Entegris AccuSizerTM (formerly known as Particle Sizing System AccuSizer) liquid particle counter to qualify the cleanliness of the Entegris Aramus single use 2D bag assemblies.

  • As novel therapies produced and stored under extreme conditions become more common, containers that were adopted decades ago are increasingly unable to meet project needs and regulatory standards. New single-layer assemblies, made with more robust materials and without the curing agents, antioxidants, plasticizers, or adhesives that represent potential contamination sources, may offer companies a safer, more efficient choice.

  • This application note reviews the chemical compatibility of Aramus™ assemblies with dimethyl sulfoxide (DMSO), which is commonly used as a cryopreservant in the cell and gene therapy (CGT) markets.

  • This application note explores the cryogenic temperature compatibility of the Aramus™ bag assembly material through freezing and drop testing after 24-hour minimum immersion in the liquid nitrogen (LN2) vapor phase.

  • This application note demonstrates how the Nicomp Z3000 system is ideally suited for determining size and zeta potential of gold nanoparticles.

  • Understanding the cold chain supply scale-up challenges that can threaten product integrity — during freeze/thaw, storage, and shipping — empowers manufacturers to implement efficient, cost-effective solutions.

  • Liposomes are spherical engineered particles made of phospholipids used in the pharmaceutical and cosmetic industries. The size and surface charge of liposomes are important characteristics which require measurement and monitoring. Dynamic light scattering (DLS) is the most common analytical technique used for measuring the size of submicron liposomes. Single particle optical sizing (SPOS) is used to measure the size of liposomes greater than one micron. The Entegris Nicomp® DLS system and AccuSizer® SPOS system are used in laboratories around the world for the accurate measurement of the size and charge (zeta potential) of liposomes.

  • Nanotechnology has been referred to as potentially being the next technical revolution that could change the modern world. Global government investment exceeds $9 billion annually and growing. 

  • This paper will discuss the results of applying an approach using sensors and more suitable material to a frozen shipping study of single-use fluoropolymer bags.

  • This paper is intended to help those new to particle size analysis understand each technique’s various strengths and weaknesses in order to select the proper technique for their samples.

  • This application note demonstrates the capabilty of advanced, automated systems for subvisible particle testing in injections, ophthalmic solutions, and lipid emulsions. 

  • This paper explains how single-use bags perform during freezing, storage, and thawing steps and why they present an efficient alternative to vials in a variety of upstream cell banking applications.

  • Speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population.

  • This paper addresses the challenges of bulk drug substance storage, shipping, and other factors users must consider in deciding whether and how they will adopt the technology. 

  • Many mAbs, vaccines, and other biotherapeutics must be reliably stored and transported at sub-zero temperatures, requiring a robust cold chain that continues throughout downstream processing.