ABSTRACT
If the project involves specially designed isolator systems to suit a particular process, then liaison with the supplier becomes a critical process, by which the project may sail through to successful validation or sink after striking the iceberg of misunderstanding. The communication process becomes even more critical if other equipment suppliers are closely involved, as in the case of isolated filling lines. Even more complications arise if, as often happens, the customer, the isolator manufacturer, and the equipment manufacturer are all in different countries. The scope for failure to appreciate the situation in each group, with consequent divergence of action, is all too wide in this situation; thus, a very professional approach will be needed by all those involved.
