Refine by
Aseptic Filling Articles & Analysis
5 articles found
In today’s highly regulated industrial landscape, ensuring SIL2 compliance in additive manufacturing and pharmaceutical production is critical. These sectors rely on accurate, safe, and compliant equipment to maintain operations and protect both employees and end-users. One standard that has emerged as a benchmark in safety-critical processes is SIL2 compliance. This article explores what ...
Here we will talk about when these actions should take place, who should perform them, and what documentation and other activities may be necessary to ensure that you enjoy the quality and contamination control benefits of a well-designed fill line with QbD. When QbD planning should occur as part of the fill line specification process. ...
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. ...
In the past, manufacturers were required to have hard copy records as evidence that the environmental conditions for aseptic fill were maintained, these supported the release of a batch. ...
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 process simulation (APS) test. ...