Following the last blog, which discussed the regulations and guidelines surrounding advances in sterility assurance, we move on to discuss the technological progress that has made advances in sterility assurance possible.
The technological advances can be segregated into these categories:
- Sterilization and Disinfection – This is a critical process that has been revamped with the use of new technologies such as vaporized hydrogen peroxide, gamma, x-ray, and electron beam irradiation. They are used in multiple aspects of pharmaceutical manufacturing process, such as materials, packaging, process equipment, isolators, medical devices, and cleanrooms.
- Automation and Robotics – Automation is becoming more prevalent as the advantages are incredible. These advantages include efficiency, increased employee safety, reducing training overhead, eliminating human error, and increasing repeatability. A robotic system is a type of automation that has multiple axes of motion and can be programmed to perform a function. Robotics play a large part in automating many of the aforementioned processes.
- Single Use Technology – This technology eliminates the cleaning and sterilization process allowing for rapid turnover from one product to another or from one bath to another batch. Singe Use systems also decrease overall operating costs by minimizing or reducing CIP/SIP. The processes benefiting most are those around contamination and cleaning, reducing water consumption, the ability to run multi-molecules in the same facility, and small-scale commercial production with low numbers of batches per year.
Learn more about rapid microbiology methods and the impact on sterility assurance by downloading this paper.
Interested in learning more? Jump to other posts in this 3-part series:
Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological Tests – Part 1 of 3
Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological Tests – Part 2 of 3 (you are here!)
Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological Tests – Part 3 of 3