Transitioning away from stainless steel to disposables has been an important industry trend. According to a 2015 report by BioPlan Associates, 90% of biomanufacturing facilities are using single use/ disposable technologies to some degree and 69% of manufacturers and suppliers report performance improvements over the previous 12 month period due to the use of disposables. Disposable systems come pre-sterilized, which provides the benefit of a significant reduction in switchover and setup times with the elimination of cleaning and sterilization steps. This results in flexibility for manufacturers to quickly change their product lines to adapt to market needs. Leading pharmaceutical manufacturers are considering the business case for the variety of options that are now available at almost every step of the production process. Single-use technologies help to reduce both fixed and consumable capital expenditures and increase operational efficiencies. The reduction in overall operating costs stems from reduced maintenance, sterilization, clean steam, chemicals, and energy demand. Smaller runs are particularly amenable to single-use technology, as most disposable systems can produce 2,000 liters at maximum production, considerably less than the 10,000-25,000 liter production scale of many pharmaceuticals.
Another critical aspect important in newly designed or re-designed facilities is that disposable products are inherently more modular and flexible. This provides cost-savings options for manufacturing many different products in small volume using the same floor space that would have been used for a single product in a traditional model. There is also enhanced protection against cross-contamination, making it more rapid and efficient to switch between multiple products.
As a result of all these enhancements, Sartorius Stedim Biotech reported in 2015 that customers who used single-use technologies for 10 years saw a 20-30% reduction in operating costs, a 40-50% reduction in capital costs, and a 30% reduction in time-to-build as compared to traditional stainless steel technology. It’s important to consider that there are challenges and trade-offs when selecting between single-use and stainless technology, and many companies opt for a hybrid approach, combining the two technologies. One challenge is the significantly elevated regulatory scrutiny over the use of disposable technology for final formulation and filling processes. It takes much longer to qualify modifications to disposable equipment and to assess extractables data from disposable equipment as compared to reusable equipment, and in general, manufacturers must incorporate rigorous change management procedures when disposables are being used. Additionally, there is a need to demonstrate extractables/ leachables performance with disposables when a switch from reusable equipment is made.
The above excerpt is from our recent whitepaper “Strategies for Creating Flexibility in New and Legacy Biomanufacturing Facilities“. The whitepaper discusses how in recent years, pharmaceutical companies have explored improvements in manufacturing to keep up with the demand and the higher complexity of the products. This competitive landscape requires innovative adaptations to the one product-one facility model in order to capture market demand and adapt to multiple products. Access the complete whitepaper here.