1. Ensure Sterilization
As mentioned earlier, biopharma manufacturers that use stainless steel equipment in their processes must clean and sterilize it after each use. Traditionally, this is done using steam cleaning, which is time-consuming and energy-intensive. Single use technology, on the other hand, comes pre-sterilized, minimizing the initial risk of microbial contamination. These disposable products enable biopharmaceutical manufacturers to maintain high standards of product quality, focus on patient safety, and simplify their sterilization validation processes.

2. Avoid Cross-contamination
In a traditional stainless steel system, cross-contamination is a critical concern, as it can compromise the quality and integrity of not only the production process, but also the final product. Single use technology is designed to be disposable, meaning it practically eliminates the risk of contamination carryover between manufacturing runs. Once a single use component has been used, it can be discarded and replaced with a fresh, sterilized product.

3. Reduce Manufacturing Costs
A single use cell culture bag, for example, is incredibly cost-effective compared to the resources required to maintain, clean, and sterilize traditional steel bioreactors. Without the need for extensive cleaning or validation procedures, single use technology saves biopharma manufacturers on cost and labor, demonstrating early return on investment (ROI). A consistent, reliable supply chain of single use solutions helps optimize production schedules, minimize downtime, and increases overall process efficiency, leading to quicker speed-to-market for life-saving therapies.

4. Increase Operational Efficiency
Operational efficiency is another key driver for the industry, helping manufacturing companies meet the increasing demands for biopharmaceutical production. In addition to eliminating the need for cleaning and sterilization steps, single use technology enhances operational efficiency by simplifying equipment setup with easy integration for disposable bags, tubing, transfer sets, filters, and other components in upstream and downstream processing. This enables operators to focus on higher-value tasks while maximizing productivity and output.

5. Improve Process Flexibility
A stainless steel system requires a dedicated production line, often for a single product or manufacturing step. For biopharmaceutical companies, this translates to a low degree of flexibility, requiring substantial lead time for modifications and complex reconfiguration processes. In contrast, single use components like tubing come in a wide range of specifications and can be quickly and easily modified to facilitate rapid process changes. This enables manufacturing companies to remain agile and respond swiftly to evolving process demands.

6. Compliance and Risk
Compliance with regulatory and clinical standards is paramount in the biopharmaceutical industry. Presterilized single use technology is traceable, as it comes with a trail of documented quality and regulatory data, which can simplify compliance efforts and minimize risks. Utilizing single use products – and working with a supplier that prioritizes quality – can minimize the risk of poor chemical composition and reduce particulate matter that might otherwise lead to safety and efficacy issues in the final product.

7. Reduce Environmental Impacts
The use of traditional stainless steel in pharmaceutical manufacturing requires high energy consumption and chemical agents used in the equipment-cleaning and sterilizing process that can impact environmental health. Single use materials can help reduce water usage by as much as 85% compared to stainless steel systems to minimize these impacts, as well as the use of chemicals such as caustic and acidic chemicals used in CIP and SIP procedures.¹ While waste from single use plastics is a significant source of pollution globally, especially when it comes to consumer goods, waste from single use biopharma manufacturing components accounts for only about 0.01% of total plastic waste.²

Waste derived from biopharma activities continues to be an industry-wide area of concern. In recent years, organizations such as Bio-Process Systems Alliance (BPSA), The Global Commitment, and Biophorum, along with others, have led the charge to affect industry-wide changes to reduce the environmental impact of biopharmaceutical manufacturing while ensuring drug product manufacturing can continue to efficiently deliver critical therapies to patients in need.