In the dynamic landscape of bioprocessing, the adoption of single-use technology has not been without its share of challenges and considerations. Initially met with skepticism due to concerns about sustainability, operational equivalence, and scale limitations, the question arose: Could single-use be a viable option for bioprocessing operations?
To prevent cross contamination in stainless steel processing equipment or components, bioprocess engineers must develop and validate clean-in-place (CIP) procedures that remove all residual proteins between processes.
CIP cycles typically use large quantities of caustics, acids and water-for-injection (WFI), and they require regular testing to verify effectiveness. Making simple equipment and components changes such as adding a new valve may require partial or complete CIP revalidation, increasing time and labor costs.
Today we would like to focus on the single-use components, which the adoption was initially slow, with challenges. There were concerns initially; however, single-use components present compelling advantages across various dimensions gradually.
Advantages of Single-Use Technologies
Eliminations of CIP/SIP sanitization
As per ASME/BPE guidance, cleaning stainless steel and permanent product-contact surfaces involves CIP and often SIP. These cycles consume time, purified water, and electrical/thermal energy. In contrast, replacing single-use materials is quick and doesn’t require purified water or energy during changeout.
Elimination of potential cross contamination
Single-use components, when used, are promptly discarded, effectively minimizing the risk of residual materials. This approach significantly reduces the potential for cross contamination, contributing to enhanced safety and operational efficiency in the manufacturing process.
Since tubing, connectors, biocontainers and filters are used only once, proteins from other processes cannot be introduced.
Which option boasts superior speed and cost efficiency – single-use or stainless steel?
The flexibility, coupled with reduced time for cleaning of single-use products, translates into substantial gains of in efficiency and, ultimately, cost-effectiveness.
What is the key to the future of pharmaceutical manufacturing: single-use or stainless steel components?
The journey through the realm of bioprocessing reveals a nuanced interplay between single-use and stainless steel components. As we navigate this intricate terrain, the pivotal question remains: Which direction will lead the industry toward a future that is not only more efficient and sustainable but also adaptable?
Just as the advantages mentioned, embracing the advantages of single-use products may be the pathway forward, offering a solution to the needs of pharmaceutical manufacturing.
Critical Factors in Decision Making
You also might take into consideration the following:
Risk Management
Address risk management considerations associated with the use of single-use and stainless steel components in bioprocessing. Discuss strategies for mitigating risks such as material compatibility issues, integrity failures, and supply chain disruptions to ensure uninterrupted manufacturing operations.
Product Quality and Consistency
Examine the impact of single-use and stainless steel components on product quality and consistency. Discuss any differences in product yield, purity, and other critical quality attributes between the two options, as well as any factors that may influence product consistency.
Regulatory Compliance
Address regulatory considerations associated with the adoption of single-use and stainless steel components in bioprocessing. Discuss any specific regulatory requirements or guidelines governing the use of these components, and how manufacturers can ensure compliance while maximizing operational efficiency.