Sterility testing has long held a very crucial importance in the biotechnology and pharmaceutical industries. It is a process that guarantees no microbial contamination in products.
With the endless advancements in the field of medicine, there have been increasing number of challenges associated to sterility testing. However, CMDC labs has been on the forefront of these challenges by incorporating methods and techniques that are innovative.
The Classical Sterility Testing Methods
Back in the times, sterility testing was done through conventional methods such as direct inoculation and membrane filtration. These methods showed results and were effective but accompanied their own set of drawbacks. One of the major disadvantage of these techniques was its requirement of a lengthy incubation period along with a greater chance of human error.
Other than this, these methods were not convenient or suitable for all sorts of products especially those that had a very complex formulation. This lead to an increased need for a method that was fast and reliable but also versatile so it would target a number of different formulations.
The Current Challenges in the Field of Sterility Testing
1- The products are much more complex
Pharmaceutical formulations are now much more complex owing to the biologics, combination products and complicated delivery systems. This id why the traditional and old-school methods of sterility testing are proved to be inadequate.
2- The need for rapid results
Today’s healthcare environment is dominated by a very fast pace. This has lead to a strong need for immediate sterility testing results.
Traditional methods often requiring multiple days to even weeks become impractical in such situations where time holds due importance for example in clinical trials.
3- Keeping up with the regulatory processes
The regulatory processes for sterility testing is continuously advancing. Manufacturers are required to go through a complicated set of guidelines to make sure they are complying. This has led to an increment in pressure of upholding high standards all while adopting to the ever changing regulations.
Advancements in Sterility Testing
To ease up these challenges, CMDC labs has incorporated advanced and innovative technologies along with methods in the field of sterility testing.
This transition boost the efficiency and accuracy of testing but in addition to that go perfectly with the industry’s shift to more flexible along with quick processes.
1- Rapid Microbial Methods (RMM)
One of the most breakthrough advancements in sterility testing is the incorporation of Rapid Microbial Methods or RMM.
These set of techniques utilise a combination of technologies that are able to speed up the identification process of microbial contamination.
2- Automation and Robotics
CMDC labs has successfully incorporated automation and robotics in its process of sterility testing. Automated systems are able to perform repetitive tasks with increased precision decreasing the chances of human error.
An example of the robotics includes the robotic pipetting system that can handle sampled with accuracy therefore providing results that are consistent yet accurate and reliable.
In addition to this, automation has also allowed industries to process a large number of samples in a very short period of time.
3- Advanced Data Analytics
Data analytics have played a prominent role in the present day sterility testing methods.
