By Jürgen Metzger
Changeover time is considered to be the activities and the time needed between two batches to prepare the entire filling line for new production (new product, format size parts, different filling volume, etc.). This topic becomes more and more relevant, especially for isolator systems due to accessibility and flexibility.
By optimizing machines you can reduce the changeover time. This also depends on defined procedures at the drug manufacturer site to handle the changeover (Risk analyses and cleaning studies to be done, PQ, media fills, SOPs needs to be written, …). Highly sophisticated lines can often be running in at least 2 shifts, 5 – 7 days a week. Sometimes a line needs to be prepared multiple times a week for different products and the efficiency of changeover time is crucial.
Following are examples showing different steps and required times for a standard filling line and elements that can reduce the changeover time to a minimum.