Since the 1990s, polymer-based single-use technology (SUT) has become widely adopted in the biopharmaceutical manufacturing industry, complementing or supplanting stainless steel systems in a wide range of production processes. These disposable solutions—such as bags, tubing, componentry, and filters, to name a few—have accelerated manufacturing operations and reduced production costs, as they eliminate the extra steps associated with cleaning, sterilizing, and validating stainless steel equipment.
When making the change from stainless steel to single-use, biopharma manufacturers can overlook one of the most important aspects of the process – selecting the most appropriate materials of construction for their single-use solutions. So how do biopharmaceutical manufacturers choose the right materials — and why is this decision so critical in the first place?
Why Material Selection Matters
SUT products come in a wide range of polymer-based materials — each used for specific applications depending on the type of equipment and its purpose in the production process. Materials used in SUT products must be able to withstand all bioprocessing conditions, including extreme temperatures, pH fluctuations, pressure changes, varying flow rates, functional performance, sterilization, storage, and transportation requirements.
On another level, understanding the physical qualities of the chosen material will assist manufacturers with producing the most effective therapy. For instance, a specific polymer might offer the bio-inertness and temperature range for a single-use bag, but it lacks the durability needed for global transportation. To resist punctures, the material manufacturer could add another protective layer of plastic film using a different polymer on the exterior. These kinds of material considerations are critical when developing effective SUTs with specific applications in mind.
Let’s examine some of the initial criteria biopharmaceutical manufacturers must consider when selecting materials to construct single-use solutions.
Clinical Safety and Regulatory Compliance
One of the aspects of process design that can easily be overlooked when developing a biopharma process is clinical safety. It is also one of the first – if not the first – aspects to explore when considering single-use solutions. The physical materials used in the construction of these components are often subject to stringent guidelines and regulations; for example, the EU’s Registration, Evaluation and Authorization of Chemicals (REACH) governs the use of certain chemicals due to their negative impact on human health and the environment. While REACH only applies to the EU, understanding these regulations will help biopharma manufacturers choose the most optimized single-use solution for the safe administration of therapies at clinical trial sites and hospitals worldwide.
To create a safer future – and a safer, more efficient biopharma process with the patient in mind – manufacturers should comply with and understand regulatory standards that ban or suggest avoiding materials that contain additives such as di(2-ethylhexyl) phthalate (DEHP) or any other possible carcinogens.
Biocompatibility, Chemical Composition, and Extractables and Leachables
Single-use solutions must be constructed from bio-inert (i.e., biocompatible) materials to avoid adverse reactions with the cell-based fluids they come into contact with, and ultimately, the patient. Chemical composition is also critical. Biopharmaceutical manufacturers should look for a low extractable profile in the materials they select to reduce the risk of leachables that could significantly impact the final product. Certain additives like phthalates found in single-use materials such as DEHP can leach into the fluid during formulation, transfer, and storage, potentially disrupting typical cellular mechanisms.
Temperature Range
Most polymer-based materials, like polyethylene, aren’t rated for extreme cold or heat, but certain film types can be designed for meet the required ranges. Ethylene vinyl acetate (EVA) is a preferred material for SUTs that are used in cold-temperature processes. This film is used for cryopreservation applications that dip down to liquid nitrogen temperatures (approx. -196°C).
Durability
Materials for SUTs also need to be durable enough to avoid excessive damage, scratching, or puncture through regular care and handling of the product. Beyond durability, they also need to maintain high quality and consistency across each product, as defects could impact process outcomes.
Film Characteristics
The choice between single- or multi-layer film will largely depend on the SUT product and its application. Multiple layers create a gas barrier that can add durability and improve material compatibility. For extreme cold temperatures, single-layer SUTs are beneficial because they mitigate delamination that can cause breakage. Additionally, optical clarity can be crucial in SUT processes that require visual indicators or measurement. Films designed for these purposes often have polished surfaces that provide transparency and high clarity.
What Are the Ideal Materials for Single-use Solutions
Polyolefins, like polyethylene and polypropylene, are some of the most common and widely recognized polymers used in SUT materials. Capable of withstanding diverse use conditions, including wide temperature ranges, mechanical flexibility, and harsh chemicals, these materials are found in a broad range of products, from fittings and tubing to filters and bags. Single-use engineers can also fine-tune these polymer-based materials to meet specific application requirements, making them suitable for virtually any bioprocessing system.
Before starting, biopharmaceutical manufacturers must examine their processing needs holistically as they begin to explore options for the most appropriate materials of construction for single-use solutions. Selecting bio-inert components with an emphasis on quality is a must in addition to considering other critical factors such as temperature rating, durability, and transparency, based on the requirements of each step in the biopharma manufacturing process.
To learn more about Chater Medical’s customization and material selection capabilities, visit our Customization Services page.
About Charter Medical, LLC
Charter Medical, LLC has more than 30 years’ experience developing and providing specialty single-use products for bioprocessing, advanced therapies, and blood management applications, delivering solutions to the biotechnology and pharmaceutical markets.
Our 16,000 square feet of cleanroom space located in Winston-Salem, NC, is ISO 13485:2016 certified and FDA registered, with a focus on designing and supplying single-use solutions for cell growth, frozen storage, and biological fluid handling. Custom product design services are available for clients who need specialized single-use products for biomanufacturing. Our team of engineers will work with you to develop the best solution for your specific requirements.
Charter Medical is committed to providing quality products and services with an experienced staff dedicated to exceeding customer expectations, from product development to delivery and implementation.
At Charter Medical, we work closely with our sister companies, Polyzen, SanaVita Medical, and Secant Group, to provide essential products and services to life science companies. Through integrated research and development activities, we are helping to bring new technologies and therapies to market.