Cost Advantages of Single-Use Technologies - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Cost Advantages of Single-Use Technologies
Single-use technologies can help simplify equipment and facility design, thus bringing cost advantages. But how are these cost advantages realized and what criteria can be used to assess their impact? This article is part of a special issue on Bioprocessing and Sterile Manufacturing.

Pharmaceutical Technology
Volume 34, pp. s26-s31

Automation complexity

Another important feature of single-use systems is that their installation is simplified because the need for cleaning and sterilization are reduced. This reduction again translates into reduced requirements for clean steam, clean-in-place, and waste collection and treatment. Although any reduction is important, it is really this elimination of entire systems that accounts for large cost savings because it is no longer necessary to install distribution systems.

The traditional stainless-steel system needs to be cleaned and sterilized, so instrumentation is necessary to allow the timely and safe execution of all the associated controls and monitoring efforts. It is therefore important to focus on system complexity when evaluating cost advantages. Seen from an engineering perspective, an efficient way of evaluating complexity is to estimate the number of in–out (IO) points (i.e., communications points in the automation system for valve control or temperature monitoring, for example). A high number of IOs signifies a complex system with high installation and qualification costs.

Each check (e.g., valve positions, temperatures, pressure, and timers) requires several IOs. A stainless-steel system needs significantly more IOs than do single-use systems that arrive precleaned and presterilized. Single-use systems only require IOs necessary for running the process in question.

Figure 3
NNE Pharmaplan compared the number of IOs for various stainless-steel and single-use bioreactors for simple and complex designs, which differ in their degree of automation because some manual operations are definitely possible in stainless steel systems (1). As demonstrated in Figure 3, single-use systems show a potential for dramatic reductions—at least 50%—in the number of IOs. At an average price of approximately $3000 per IO, these reductions can translate to significant savings in installation costs.

Operation costs

In many cases—not including high batch-frequency operations—single-use technology compares favorably to stainless-steel equipment in terms of cost. This favorability obtains with respect to investment cost, but also with respect to variable costs when we include the cost of the capital required to operate a comparable stainless steel system. Amortization and interest over time must be added to variable costs, and many case studies show these to exceed the variable costs related to increased amount of consumables used in a single-use design.

The costs of cleaning chemicals and water-for-injection (WFI) are often included in feasibility studies. These costs are seldom the deciding factor because they are usually low compared with those of other consumables and with the cost of capital in general. This analysis is perhaps counterintuitive because of the large volumes of resources involved in cleaning and rinsing. This apparent paradox occurs because the cleaning chemicals are common and relatively inexpensive, because WFI is not used for all cleaning solutions, and because WFI from an on-site generation and distribution system is much cheaper than WFI bought as a laboratory material. In an authoritative study on disposables costs, Barnoon estimates that $0.05/L for WFI costs is realistic for large-scale operations (2).

Estimates about reductions in operator time are sometimes introduced into the comparison, and typical values include a roughly 20% reduction for single-use systems (3). This number is somewhat anecdotal, however, because few published case studies exist. Although personnel costs are important, such estimates may be realistic only for single facility functions (e.g., washing and sterilization) but not for the entire facility because cleaning, sterilization, and maintenance are, after all, not constant activities. It should therefore be possible to allocate resources from other areas during peak load periods.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here