Single-Use Systems: Cost Considerations & Environmental Impact
Lower pricing flexibility and a strong US dollar recently persuaded Moody’s Investor Services to make a modest reduction in its expectations for the pharmaceutical industry's earnings growth. Growth expectations are now 3 percent to 4 percent versus a previous expectation of 4 percent to 5 percent.1 Pharmaceutical companies are expected to implement cost saving measures accordingly. One increasingly utilized trend that can help cut costs – particularly in the biopharmaceutical space – is single-use technology. Single-use systems are made up of pre-sterilized and disposable components, typically polymer-based, that replace reusable stainless steel or glass equipment. Single-use technology increases operational flexibility and reduces risk of cross contamination – but it can also reduce operational costs and has been shown to have a net positive environmental impact.
The Bottom Line
How does disposing entire fluid contact pathways after each use cut costs or decrease environmental impact? For starters, consider the extensive cleaning and re-sterilization that must be done between batches or products in a traditional stainless steel system. This process is especially difficult for biologics, as proteins are notoriously challenging to clean. In order to clean and re-sterilize, the system must be flushed with cleaning agents and rinsed with purified water, then treated with pressurized steam. Each process requires electricity, water and labor. The raw material costs of cleaning agents, water and energy to produce steam and distilled water along with costs of chemical disposal must be considered as well. Factor in the downtime required to complete this rigorous process and the full cost burden becomes clear. A single-use system eliminates the need for cleaning and cleaning validation, sterilization and sterilization validation, and significantly reduces changeover time. A case study at a biologics manufacturer that implemented single-use showed a savings of more than one million liters of water for injection (WFI) and purified water, 28,812 kWh of electrical power, $250,000 in WFI generation costs, and $60,000 in direct labor costs.2
Can Disposable be Green?
Reducing the cost of operations and minimizing the impact on the environment are often complementary goals. This has been shown to be the case for single-use, where despite plastic waste, the technology has a net positive environmental impact. The same biologics manufacturer calculated a carbon footprint reduction of over 20 metric tons of CO2.3 Additionally, a study from GE Healthcare Life Sciences determined that “single-use bioprocessing technology exhibits lower environmental impacts compared to conventional bioprocessing technology in all impact categories studied.”4
An Industry Resource
At Pharma EXPO 2016 (McCormick Place, Chicago; Nov. 6-9), pharmaceutical manufacturers can find a number of educational resources on single-use systems. The Pharma EXPO Conference Program, powered by ISPE, will offer several sessions addressing the topic. Including a session on “Considerations for Implementing Single-Use Filling Systems” which falls on Monday, Nov. 7, as part of a day-long Manufacturing Operations Track. The session will cover benefits of single-use versus stainless steel systems, cost of ownership for single-use versus stainless steel, considerations for implementation of single use, and validation. Pharma EXPO, co-located with PACK EXPO International, is co-produced by PMMI, The Association for Packaging and Packaging Technologies and ISPE. Learn more and register today!
By: Jerry Martin, Pharmaceutical and Life Sciences Consultant, PMMI, The Association of Packaging and Processing Technologies