Automated, rapid microbial enumeration has proven incredibly effective for pharmaceutical quality control, and manufacturers have realized huge savings by automating the traditional method. However, most execs and other high-level decision makers still don't see rapid technologies as an essential expense. Plates, reagents and other lab supplies are clearly indispensable, but rapid equipment requires a large, well-justified investment above and beyond normal quality control expenditures. Here are a few of the elements you'll need to consider to determine the ROI of the Growth Direct™ System in your own company's quality control environment.
Quantitative Concerns
Exact ROI calculations will vary wildly from one company to the next, but there are a few variables every manufacturer will need to take into account. These include:
Number of tests automated: Test volume will depend heavily on production volume, as well as the amounts and types of raw ingredients, and the size of the manufacturing area, number of shifts, etc.
Required in-process tests: More ingredients and steps mean more in-process tests. The Growth Direct™ System adds value by automating and hastening the enumeration process, so the highest savings will be realized with the most complex products.
Test types: The Growth Direct™ System can automate all major quality control tests – water and bioburden, environmental monitoring and sterility testing. These tests have different time frames, however, so a company's specific use of the equipment will determine the number of days they'll save compared to the manual method.
Labor savings: Similarly, the labor hours currently spent on manual colony counting will vary according to each company's testing needs. Growth Direct™ System users who perform employ large staff may be able to eliminate or reallocate several full-time employees.
Reduced Investigations: Automatic enumeration all but eliminates human errors in both counting and reporting. While it can't prevent environmental or product contamination, these error reductions will eliminate unnecessary OOS investigations, which are initiated due to miscounts, incorrect data entry and in-process human contamination.
Times to market: With consistently shorter testing times, Growth Direct™ System users can achieve far faster times to market – especially when they typically deal with several days- or weeks-long interim tests per product. Overall, rapid methods don't just save money in QC departments; they can help a company make more!
Soft Benefits
A clear ROI is typically the most important aspect of the business case for the Growth Direct System, but there are plenty of soft benefits, which may also sway hesitant execs and board members. Taking both the short-term and long-term into account, these benefits include:
Space savings: Many quality control departments need to expand space and resources to meet increased testing demands. With the Growth Direct™ System, the expansion may not be needed, as the system handles a large volume of testing in a smaller space.
Production line testing: Because of its self-contained testing environment, the Growth Direct™ can be placed at or near production lines. This convenient placement eliminates a great deal of cross-campus travel time for QC personnel, and manufacturing workers can potentially load the samples themselves.
Going paperless: Paper elimination is a popular initiative in today's environmentally conscious corporate environment and the Growth Direct™ System’s reporting features eliminate the need for paper-based data entry.
Globally available data: For users with multiple facilities, the Growth Direct System’s reporting features also enable quick and easy data sharing between different cities, states and even countries. If contamination does slow or halt production at one facility, others can seamlessly alter their own schedules accordingly.
Learn more about the Growth Direct System and how your company can benefit. Contact us today.
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