It does not take a very in-deth analysis to conclude that while the manual method is still viable in today's pharmaceutical industry, it is ultimately cost-inefficient. The following are six ways the manual method is actually costing pharmaceutical companies time and money compared to automatic systems.
The manual method requires an enormous labor investment. Each sample must be manually incubated, transferred, counted and recorded. As additional testing, manufacturing expansion, or the requirement to do interim counts increases the number of samples, the amount of labor will increase proportionally, increasing costs. Over the course of a few years, all of this labor can cost far more than the one-time investment in the installation, implementation and validation of automatic equipment.
Time is money, and traditional testing requires days or even weeks to produce results. When plates do reveal out-of-specification levels of growth, technicians must also run further manual tests to find and identify the sources of contamination.
Due to human errors, the traditional method may also lead to several unnecessary OOS investigations each year. In-process contamination, misplaced samples, incubation errors, miscounts and incorrect data entry – each of these mishaps can lead quality control personnel on a hunt for environmental and product problems that may not be real. These investigations don't just cost labor and expendable resources; they may require manufacturing lines to be shut down for hours or days.
The manual method's tasks are simple and repetitive, but they still require the trained eyes of a well-educated and well-paid microbiologist. This amount of skilled labor not only costs a great deal, it prevents these employees from working on other critical tasks. On the other hand, RMM technologies such as the Growth DirectTM System only require technicians to prepare sample cassettes. Once that's complete, the system takes over completing the analysis so microbiologists can turn their attention to other in-process tests, investigations, interventions and more.
Every day counts when finished products are awaiting shipment. With the manual method, sterility tests, for example, can take up to two weeks to produce final results, and even interim counts require hours of additional labor. Now that RMM technologies are available, this amount of waiting is unnecessary and even counterproductive. While a company using the compendial method must either wait for final test results or ship at risk, a manufacturer employing rapid methods can get products to market quickly and consistently. As rapid methods become more prevalent in the industry, companies that stick with old techniques may not be able to achieve the reliability and speed necessary to compete.
Finally, the manual method makes it far more difficult for a pharmaceutical manufacturer to grow and expand. Whether a company wants to produce higher volumes of its current items or diversify with new products, its quality control testing requirements will grow. Of course, more testing will require proportionally more lab space and personnel.
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