Rapid microbial testing can deliver tangible benefits throughout pharmaceutical manufacturing. However, overcoming barriers is essential for manufacturers to adopt rapid testing versus traditional culture testing.
Proving equivalency and preserving samples
One barrier is the need to demonstrate that results are equivalent to those using the compendial culture method. Some technologies do not deliver equivalent results, many lack the sensitivity of the culture method, and many do not uniformly detect all types of microbes or detect microbes in all types of samples.
Certain rapid microbial testing methods currently available also destroy the microbe or require recovery techniques that are not robust and reproducible. When a test is positive, manufacturers are expected to identify the organism present in the sample as the first step in their root cause analysis to establish corrective action. To ensure the contaminating microbe is available to identify, manufacturers have stayed with the culture testing method.
Maximizing efficiency and flexibility
At Rapid Micro Biosystems, we conducted research with customers to identify these and other issues hampering the adoption of rapid methods. The research led to the conclusion that rapid technology achieving the following criteria could overcome obstacles and replace the traditional culture method:
- Mirror the current method of sample preparation. This simplifies training.
- Minimize the system footprint.
- Maximize the efficiency of the automation.
- Provide flexible, easy-to-use technology so a user can load the instrument and walk away. While a rapid answer is important, the QC lab operates with limited resources. Automation that frees resources is valuable.
- Support the unique needs of Environmental Monitoring (air, surface, personnel), Water and Bioburden Testing, and in the future, Sterility Testing (closed loop testing).
- Provide samples for identification. In the event of a variance, the QC lab must perform an investigation, which may include identification of the contaminant. Having a sample available solves this problem.
- Incorporate “lean lab” initiatives. The last few years have seen an increase in the need to drive efficiencies in the QC lab through initiatives such as “lean lab.” A method that includes automation to eliminate wasteful steps and improve efficiency is a positive factor in adoption.
Replacing traditional methods
The Growth Direct™ System from Rapid Micro Biosystems achieves these criteria, eliminating the need for manufacturers to continue to use traditional, time-consuming, and inefficient culture testing methods.
Learn more about all that ways that the Growth Direct System overcomes obstacles to adoption of rapid microbial testing.