Explanations about limitations of conventional bioburden testing

While most pharmaceutical manufacturers have adopted new, Automated methods in their manufacturing processes, many are slow to embrace cutting-edge practices and equipment for microbial excellent control. In regards to microbiological testing, the century-old manual technique remains the standard, and many firms are spending countless hours of highly skilled labour on repetitive tasks. Luckily, rapid microbiological methods are fast gaining popularity among producers and regulators alike. Regulations have changed to make the migration to RMM simpler than previously. These changes, and the additional benefits of labor savings, reduced OOS investigations make it advantageous to move away from the standard method. Here are just five of frequent and impactful limitations of this manual technique.

Time Required

The conventional method requires time for germs to grow and Multiply to be seen by the human eye. After the colonies are visible, ever plate has to be counted and recorded. Highly valuable trained microbiologist time is wasted assessing countless dishes many of which may not have any contamination. Together with the Growing Directs System reduces the total evaluation time by roughly 50%. Since the machine reads the plates daily, it may detect contamination beginning in hours. Moreover, the system automatically manages the countless dishes reading, recording and reporting results automatically, saving precious microbiologist time. Testing Accuracy is crucial in the insecure, highly regulated pharmaceutical industry, and guide colony counting allows for a wonderful amount of human error. Colonies must grow to millions of cells before they can be detected by the naked eye, as well as the most well-trained and expert technicians can miscount.

When dealing with stringent specifications for acceptable levels of bioburden testing, this degree of inaccuracy can easily result in both unnecessary OOS investigations and undetected contamination. Some tests need serial incubation, where samples are Transferred from 1 incubator to another at a different temperature at a particular time. RMM technologies like The Development Directs System automate this procedure. The manual method requires additional human intervention, while whenever a tech transfers a sample, there is potential for an error, which might cause an out-of-specification event. Even When technicians perform their guide counts perfectly, there is a chance for error when they record the counts on paper or in their LIMS. Whether they have exhibited growth or not, each sample has to be accounted for, and technicians may make mistakes when dealing with hundreds of samples.