Aseptic Processing Fill Articles & Analysis
4 articles found
Over the previous five Blogs in this series we have discussed the critical quality attributes to consider in a robust Quality by Design plan for the construction of a new Isolator/RABS fill line. The primary topics we explored are: Regulatory, Surround Areas, Cleaning, Process Interventions and Environmental Monitoring. Here we will talk about when these actions ...
Aseptic technology has become well established in the food and drink sector, yet some businesses are still unaware of its benefits or do not believe that it can be used with their products. In most cases, hot filling sterilises the container as the product (which is still hot from cooking or sterilising) is filled. However, the temperatures required often have unwanted effects on the quality of ...
In 2015, ISO updated their Standard 14644 to include data integrity issues that allowed manufacturers to use validated systems to electronically store, analyze and report their product and process data. This was a great benefit to the industry as it gave manufacturers and auditors a template to agree on for accepted standards of electronic data. In the past, manufacturers were ...
The bioburden assay should be performed for each batch for both aseptically-filled products and terminally-sterilized products. Use the results as part of the final batch review. Aseptic Process Simulation Validation of aseptic processing should include an aseptic ...