Fill and throw away
Disposable Filling System: an alternative for sterile filling in aseptic processes

The Acerta System is a new liquid filling system for sterile fill and finish operations that speeds operations by eliminating the need for autoclaving, steam-in-place and the aseptic assembly of filling machine pump parts. Offering a closed pre-sterilized disposable assembly, it eliminates the need for clean-in-place and reduces the risk of product cross contamination. It also provides complete containment of products, ensuring safety of personnel as well as product sterility.
For years, pharmaceutical manufacturers have been under intense pressure to improve their methods of cleaning, sanitizing and sterilizing equipment used to make sterile drugs. These procedures must be validated and include an on-going program to re-validate. This is an expensive and time consuming effort. To address this problem, manufacturers have been looking to disposable technologies that minimize or eliminate cleaning, sterilizing, and validation. One area where this disposable technology has gained acceptance is in fluid storage. Instead of using stainless steel tanks, large sterile plastic bags are commonly used for product storage. After use, the empty bag is disposed, eliminating cleaning and sterilization as well as re-validation of these processes. Now there is a new technology for final filling of sterile injectables to take advantage of the benefits offered by disposable technologies.