Isolator Good Operating Practices
In this workstream, we create industry-wide good practices for using isolators in aseptic filling operations.
There is little published good practice to ensure effective operation and the introduction of newer technologies/practices
Isolators are increasingly used in aseptic filling operations, however, there has been little published good practice to ensure effective operation. Hence there are many different approaches from both equipment vendors and end users. This results in inconsistent practices and lots of variability.
Deeper process understanding
The goals of the workstream are development of deeper process understanding and reduction in variability within operations. The team hope this will result in:
- Improved compliance and fewer investigations related to the operation of isolators
- Fewer deviations and failed batches
Isolator Good Operating Practices deliverables
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