Before and during a manufacturing processes with high Containment requirements, various facts have to be analysed very critically. A disregard can cause a severe risk for the product, the user and even for the end-customer. It is essential to pay attention to the relevant FDA regulations, different ATEX-guidelines as well as the following points in order to avoid exceeding the previously defined customer-limits such as OEL (Occupational Exposure Limit).
First of all it is necessary to be aware of all important interfaces in your manufacturing process in order to reach a specified Containment level. In addition, the system has to be adjusted to the product and its product specific properties (e.g. particle size or flow rate).
Before desinging single system components and their connections to the exhaust air - and filter-units, it is crucial to make sure that the whole system is closed. Furthermore, you should pay attention to the possibility for a residue-free cleaning before starting the development process.
One of the most critical interfaces is the connecting and undocking of the bundles and following the in-house transport to the subsequent process step. The main responsibility is here transferred to the operator. Special trainings in advance can reduce the risk of mistakes and operator errors.