The Rise of Single-Use Systems in Process Manufacturing
In recent years, process manufacturers have increasingly turned to single-use equipment for a variety of reasons. Single-use systems offer several advantages that make them an attractive option over traditional reusable equipment.
Reasons for Switching to Single-Use Equipment
- Eliminate Cleaning Requirements: Single-use systems remove the need for extensive cleaning, which saves time and resources.
- Reduce Cross-Contamination Risk: Since each batch uses fresh, disposable components, the risk of cross-contamination is significantly minimized.
- Lower Capital Investment: Single-use equipment requires less initial capital outlay compared to permanent installations and stainless steel systems.
- Accelerate Facility Setup: Single-use systems can drastically shorten the time required to get a facility operational.
- Flexible and Modular: These systems offer flexibility with a modular approach, allowing for easy adjustments and scalability.
Advantages of Single-Use Processing Equipment
Single-use equipment addresses many issues associated with traditional reusable equipment, such as stainless steel bioreactors and purification instruments, particularly in relation to clean-in-place (CIP) and sterilize-in-place (SIP) processes.
Benefits of Single-Use Systems
- Faster Speed to Market: Single-use systems enable quicker duplication of production runs, minimizing downtime and reducing risks of cross-contamination and human error. This efficiency translates to a faster time to market.
- Enhanced Flexibility: Manufacturers can produce multiple products in a single facility, switch equipment between different processes, and scale up or down as needed. Single-use systems can be implemented in various settings, even those lacking steam, purified water, or waste recycling facilities.
- Lower Capital and Utility Costs: Single-use systems reduce the need for extensive infrastructure, such as cleanrooms and sterilization systems, leading to lower capital expenditures and utility costs. This also means a smaller facility footprint, potentially reducing real estate and tax expenses.
- Minimized Cross-Contamination Risk: With each process using new, sterile equipment, the risk of introducing contaminants is drastically reduced. This results in more consistent and higher-quality outcomes with less waste.
- Sustainability and Energy Savings: Single-use systems significantly reduce water, steam, and chemical usage for cleaning, thereby offering environmental benefits and energy savings. The reduction in resource consumption leads to a more sustainable manufacturing process.
- Reduced Labor Costs: The simplicity of setting up and breaking down single-use systems, along with the elimination of cleaning steps, reduces labor costs. Additionally, single-use systems do not require recalibration of equipment, further decreasing the need for specialized personnel.
Single-Use Systems in the Biopharmaceutical Industry
The biopharmaceutical industry is increasingly adopting single-use disposable systems for the development and manufacturing of vaccines, therapeutic proteins, and monoclonal antibodies (MAbs). These processes involve multiple steps with varied conditions and objectives, making single-use systems ideal due to their flexibility and reduced need for CIP/SIP procedures.
Challenges and Considerations with Single-Use Systems
Despite their many advantages, single-use systems come with challenges, particularly related to their polymeric components. These components, which include membrane filtration devices, bags, connectors, tubing, and fittings, raise concerns about microbial retention, sterility, bacterial endotoxins, and biosafety. Functional issues such as flow rates, burst strength, temperature, and pressure resistance also need to be addressed.
A significant concern is the potential for extractables and leachables, which can impact the impurity profile of the drug substance. Given the variety of polymers used, there is a high risk of different compounds and their degradation products leaching into the drug product. Manufacturers must quantify these substances and assess their impact on drug purity. Detailed information from suppliers regarding extractables is crucial for conducting leachable studies.
Conclusion
Single-use systems offer numerous benefits, including increased speed to market, greater flexibility, reduced costs, and lower contamination risks. While they present some challenges, particularly regarding extractables and leachables, the overall advantages make them an increasingly popular choice in both the beverage and biopharmaceutical industries. By addressing these concerns, manufacturers can leverage single-use systems to enhance efficiency, sustainability, and product quality