Aseptic Blowing Filling Articles & Analysis: Older
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 ...
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 should take place, who should ...
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 ...
Benefits of Paperless Reporting in Pharmaceutical Manufacturing Paperless pharmaceutical manufacturing sites are a relatively new concept. 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 ...
All starting materials should have minimal microbiological contamination. Your contamination control strategy should document the quality of the materials in terms of microbiological monitoring or other requirements. 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. ...