Pharmaceutical companies have been implementing automation in their manufacturing processes for years, but many are still using century-old techniques for quality control. Due to technological advances, automated methods are now available for microbial tests, too. Instead of spending countless hours on manual colony counts, quality control departments can rapidly automate the process from start to finish.
Not all rapid methods are alike, though. Some systems include all new techniques for sample collection and enumeration, which require additional training and validation from their users. On the other hand, the Growth DirectTM System allows samples to be collected similarly to the compendial method, and international regulators have noted its similarity to the traditional test.
Still, quality control is an often-overlooked aspect of production, and most decision-makers are slow to make long-term investments in laboratory equipment. Quality control personnel who see the value in rapid enumeration will need to make solid business cases based on the clear ROI of the equipment they need.
For the Growth Direct™ System, overall testing volume will be one of the most impactful figures in determining this ROI. The following are the most important factors that contribute to current and future requirements for microbiological tests.
Product Variety: Some pharmaceutical companies produce just a few brand-name or generic products, while others manufacture large varieties and multiple brands. Since each distinct item will carry its own testing requirements – no matter how small its production volume – a larger product variety typically results in a larger testing volume and greater potential ROI in switching to rapid methods.
Internal policies and external regulations alike require that manufacturers test certain proportions of each raw material, finished product and production environment. Even without an expansion into new products, an increase in production volume typically leads to an increase in testing volume.
When assessing product test volume, products with sterile requirements that generally require more and longer testing should be included as part of the ROI.
Complex manufacturing processes also tend to require tests for intermediate products at every step. These processes are manufacturers' greatest opportunities to save on quality control labor and the potential downtime related to unnecessary investigations.
The Growth DirectTM System allows for long-term ROIs, and users will need to weigh their future testing requirements just as heavily as their current volumes. Companies that expand production of their current products may see a linear increase in their testing volumes, while those that add new and more complex products may see far more rapid growth in their requirements.
To learn the other components necessary to determine your company's ROI, download our new guide, “Quantifying the Economic Benefits of The Growth DirectTM System.”