Case Study: Justifying RMM for Environmental Monitoring
To illustrate how ROI and PP can be used to justify the implementation of a new RMM, one pharmaceutical company investigated ways in which it could employ an alternative microbiology method for environmental monitoring (EM). The company determined that active air sampling was the most labor-intensive and expensive component in its EM program, and identified an optical spectroscopic RMM, the BioVigilant IMD-A, as a potential replacement for its existing agar-based bioaerosol sampling procedure. Because the IMD-A continuously monitors both viable and nonviable particles in real-time, eliminates manual sampling and laboratory testing, and does not use consumables or media, the company presumed it could realize significant cost savings by implementing this RMM.
The company gathered monetary values for each operating cost and cost savings component for use in ROI and PP calculations, and applied these calculations to one of its aseptic manufacturing facilities. The facility processes 100,000 air samples per year. Manufacturing is peformed in conventional cleanrooms and the process is personnnel intensive, resulting in the rejection of three $500K product lots per year due to EM excursions on conventional media. This site also shuts down a line three time per year to conduct EM investigations. Tables 1-3 provide detailed information about the financial components that will be used in the ROI and PP models.
Table 1. Operating Costs for Conventional Methods vs. RMM
- Because the IMD-A operates continuously, in this example we will assume that the actual number of tests performed can be reduced by a factor of 5 as compared with the CM.
- Depreciation for IMD-A equals 10% of capital cost (assumes 48 units at $90,000 each; pricing used is representative and is for calculation purposes only, as the supplier may vary the price based on configuration and quantities purchased).
- Annual maintenance and service contracts start in year 2 and are based on geographic region and services contracted. Pricing assumed equals 12% of capital cost (48 units at $90,000 each).
ROI and PP Results
The manufacturer calculated the ROI and the cost savings for the first year, the second and subsequent years, and the total ROI and cost savings for a five-year period. The PP was also determined. A summary of these results is provided below.
The ROI and PP data generated for this facility clearly demonstrate sufficient economic justification for initiating a qualification and implementation plan using the chosen RMM as an alternative method to conventional active air sampling. Additionally, the PP is relatively short due to a substantial cost savings during the first year of implementation. From a business perspective, the use of this RMM would directly impact the company’s bottom line and should satisfy the financial expectations of site management.
The ROI models presented here can be applied to any RMM, although there will be different line items for each technology, such as cost per test, capital cost, maintenance agreements, labor time and laboratory overhead. With the BioVigilant system, because there are no consumable costs, overall cost savings will be greater than for most or all RMMs currently available. Nevertheless, whatever the RMM, calculations such as these will go a long way towards clarifying ROI and therefore justifying investment in these technologies.
When developing a strategy for introducing RMMs in the manufacturing environment, the use of financial models, such as ROI and PP, can play an important role in providing the necessary justification for purchasing the capital equipment and initiating the qualification program. A robust economic assessment coupled with a comprehensive implementation plan is the key to successful RMM installations and the continuous improvement of manufacturing processes and operational efficiencies.
About the Author
Dr. Michael J. Miller is President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). He is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, Process Analytical Technology (PAT), isolator design and qualification, and the due diligence, validation, registration and implementation of rapid microbiological methods. Over the past 20 years, Dr. Miller has held numerous R&D, manufacturing, quality, consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc.
Dr. Miller has authored over 90 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on a number of PDA’s program and publication committees and advisory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods.
Dr. Miller may be reached at firstname.lastname@example.org.