Single-Use Media Products For Biopharmaceutical

Single-use products for biopharmaceutical manufacturing was very limited in scope only a few years ago, with the industry favoring traditional stainless steel process methods. In recent years, however, trends have quickly changed, fueled by the rising demand for biopharmaceutical products. In response to customer demand, biopharmaceutical manufacturers have increasingly turned to single-use technologies (SUTs) at various points in the manufacturing process due to the many advantages they offer. To understand this trend, you need to know the details behind single-use technologies manufacturing, the advantages it offers and how it can be leveraged in biopharmaceutical manufacturing.

Single-Use Technologies Manufacturing

Since biopharmaceutical manufacturing was pioneered in 1977, the industry has gone through many significant changes, especially in the area of applied technologies. Originally, the industry made use of reuseable stainless steel and other recyclable materials, all of which were sterilized and re-sterilized after every process. The issue with this procedure was that sterilization was time-consuming, expensive in labor and materials and left room for human failure, all of which directly impacted costs and product quality. These failures and cost-inefficiencies drove biopharmaceutical manufacturers and other high-purity manufacturing operations to seek alternatives. In the early 2000s, single-use technology came into play.

Single-use technologies are defined as sterile components that can easily be attached to a system and disposed of after use. Some examples of single-use technologies include tubing, capsule filters, mixers, bioreactors, sterile bags, connection devices and sampling receptacles. While larger equipment in a system may still consist of stainless steel components that require sterilization, smaller or connecting components can be easily changed out and disposed of, reducing the need for sterilization. In just the past five years, the application of these single-use technologies has increased in application breadth and scalability. With time, however, many experts foresee a transition to entirely single-use systems.

Single-Use Media Products We Offer

Sentinel Process Systems, Inc. offers a variety of single-use media technology for biopharmaceutical manufacturing. Our single-use products are listed below:

• Bioprocess bags: Sentinel’s line of Bioprocess Bags is available in a variety of standard designs, as well as custom designs with short lead times.
• Cryopreservation bags: Single-use Aramus™ 2D bag assemblies make it easy to safely store, transport and thaw drug substances. These bag assemblies offer superior chemical resistance and eliminate the risk of delamination.
• Tank liners: Sentinel offers tank liners in irradiated and non-irradiated options with either top or bottom dispensing capabilities. There are also several options in film materials, liner sizes and connections.
• Motion reactor bags: the motion reactor bags can be used in a variety of capacities. Available in single, double and triple barrier options, these bags adhere to USP Class VI standards and are sterilized using gamma irradiation, ensuring that they offer the sterility and performance our customers require.

This range of products provides just a glimpse at the options available in single-use technologies for biopharmaceutical manufacturing.

5 Benefits of Single-Use Technology

Single-use technology has quickly gained traction over the last decade due to the range of benefits it offers. But what exactly are those advantages? The most prominent benefits are listed in detail below.

1. Reduced cleaning requirements: Traditional equipment made of stainless steel and pipework must be repeatedly sterilized using steam cleaning and heat treatment procedures. This requires a great deal of energy and water, as well as labor. Single-use equipment, on the other hand, is sterilized by the manufacturer and sent to the user in a sterile state. While some manufacturers are wary of trusting a third party to handle sterilization, many see the benefit of eliminating sterilization procedures wherever they can. Usually, pre-sterilization is achieved using gamma irradiation or other treatments. Since the equipment is disposed of and replaced with each new use, there is no need for cleaning and sterilization procedures.
2. Improved turnaround times: Traditional equipment must be cleaned between each use for the sake of product quality, and this results in costly downtime that increases product turnaround. Single-use technology allows manufacturers to quickly install and uninstall processing paths between batches without needing to wait for cleaning procedures. This allows for quicker turnaround times and improved time-to-market, which is beneficial to the company’s bottom line.
3. Increased flexibility: While stainless steel systems are more permanent and recyclable, they are not easily modified when processes change. Any changes in process mean that piping needs to be cut, components need to be replaced and everything needs to be moved around, all of which costs time and money. Single-use technologies, on the other hand, are highly modular and easily reconfigured into new flows. With single-use technologies, manufacturers can change their processes as needed, allowing a greater level of flexibility. This is especially important for small-scale manufacturers that primarily work with smaller batches and quantities.
4. Reduced contamination risk: With traditional stainless steel equipment, each process must be followed by a sterilization procedure. The issue is that the sterilization procedure must be completed by a person and executed perfectly. Any missteps in the sterilization procedure may result in cross-contamination between batches, which can significantly reduce product quality. With single-use technology, however, modules are discarded and replaced after each batch, improving sterility assurance and eliminating human error.
5. Decreased manufacturing costs: Traditional stainless steel processes require considerable on-site infrastructure. Manufacturers must purchase permanent equipment and dedicate space and more equipment for processing and cleaning. Single-use products for manufacturing eliminates these requirements, while also reducing labor costs and improving product quality and turnaround. All of these factors help to maximize profits for biopharmaceutical manufacturers.

Common Applications For Single-Use Products

While the range of single-use products and their benefits is impressive, it’s important to understand how disposable technology is used and the impact it has had on various industries. Most substantial is the impact of single-use products on the pharmaceutical, bio-processing and other high-purity manufacturing industries.

• Pharmaceutical manufacturing: Single-use products are quickly becoming a staple in the pharmaceutical manufacturing industry at every level. Driven by cost efficiency and quality requirements, the pharmaceutical industry has quickly adopted single-use components because of their cost-effectiveness and sterility relative to stainless steel equivalents.
• Bio-processing manufacturing: Bio-processing manufacturers are also embracing the trend toward disposable technologies. Much of this is driven by the increasing demand for biologics and biosimilars and the need to find cost-effective and scalable options. With recent advances in technology and supply chain optimization, bio-processing manufacturers are increasingly turning toward single-use options.
• Other high-purity manufacturing: Other high-purity manufacturing operations, especially in the chemical industry, require highly sterile equipment to avoid cross-contamination. In these fields, single-use technologies have expanded in use to eliminate traditional processing technologies and costly sterilization procedures.

Single-use products are also gaining traction in other industries that rely on product quality and sterilization procedures. For example, the food and drink industry and the cosmetics industry both rely on product quality and thorough sterilization procedures and greatly benefit from the use of single-use technology in their flow processes.

The Future Of Single-Use Products In Biopharmaceutical Manufacturing

While single-use products in manufacturing processes have posed numerous benefits, there is still plenty of room for these technologies to improve. Some specific areas of advancement industry professionals expect within the next decade are described in more detail below:

• Universal standards: With the popularization of single-use technology in manufacturing, suppliers have gotten better at producing these single-use products. Designs are becoming increasingly complex to meet the growing need for entirely disposable flow processes. However, the challenge lies in the supply chain. Manufacturers often source components from multiple suppliers, increasing the complexity of their orders and processes and introducing the risk of ordering components that don’t fit. Professionals in the industry expect that suppliers are going to move toward universal standards in single-use product designs, allowing their customers to benefit from more cohesive systems and simpler supply chains.
• Increased capabilities: Because single-use systems eliminate the need for sterilization processes, they are becoming increasingly popular among manufacturers, and the idea of entirely disposable processes has become more pronounced. With entirely disposable flow systems, manufacturers would use the system once and replace all the parts with the next batch. To achieve this, however, single-use products must become more sophisticated. While many new components like diaphragm valves, pumps and bioreactors have come into play, professionals in the industry expect to see even more advanced components in the near future.
• Improved scalability: At present, single-use technology is best suited to small-scale productions. Smaller manufacturers require greater flexibility, which single-use products can offer. Large manufacturers, on the other hand, are more concerned about the supply chain and their turnaround times. While some larger manufacturers are turning to single-use products for certain aspects of their production, widespread implementation is still rare. Professionals in the industry expect the usage of single-use technologies to expand to manufacturers of all sizes as the technology becomes more scalable.

As the market for single-use products grows, so too will the technology. Industry professionals expect that as disposable technology becomes more popular, the technology itself will evolve to further meet the needs of the industry.

Choose Sentinel Process Systems

The various advantages of single-use disposable technologies are extensive, posing major benefits to biopharmaceutical manufacturers of all types and sizes. However, as beneficial as these technologies are, their benefit relies on their quality. Sub-par disposable products can negatively affect systems through improper sterilization techniques or product composition. To avoid this issue, companies need to partner with a distributor they can trust to achieve peak results every time. If quality is what you seek, Sentinel Process Systems can help.

Sentinel Process Systems, Inc. is a distributor and reseller of various innovative technologies for high-purity industries. We distribute and fabricate high purity valves, process instrumentation, single-use products, process hose, fittings and more. Whether your company is in the pharmaceutical, biotech, cosmetics, food or high purity chemical industry, we can provide unique and tailored solutions to suit your needs.

Since 1950, Sentinel has delivered quality products and innovative technologies to help customers achieve the results they need to get the job done. Across our multiple locations, Sentinel’s facilities cover over 14,000 square feet of office, warehouse and fabrication space and are staffed by experienced and innovative team members. Combined, we serve a range of customers across the Mid-Atlantic, Carolinas and New England regions.

Are you interested in learning more about Sentinel’s options in single-use technology for biopharmaceutical applications? Contact us today for information or a quote.

• Single-Use Tubing Solutions
• Single-Use Connectors
• Flow Control