Containment in the manufacturing process

In manufacturing processes with high containment requirements, there are some factors that need to be considered particularly critically. Neglect can pose a risk for the product, operator and end customer that should not be underestimated. Apart from the relevant regulations of the FDA or the ATEX directives, the points described below must be consistently considered and implemented in order not to exceed the limit values defined by the customer, such as OEB or OEL.

First and foremost, it is necessary to include all interfaces of the manufacturing process in order to be able to achieve a certain containment level at all. In addition, the system must be adapted to the respective product with its product-specific properties (e.g. particle size or flow behavior). When designing the machine components and their connections to the exhaust air and filter systems, care must be taken to ensure that the systems are closed.

Likewise, the possibility of residue-free cleaning must already be considered during the development of the system. One of the most critical interfaces is the docking and undocking or the loading and unloading of the containers as well as the internal transport to the subsequent process step. The operator in particular has a great deal of responsibility here.

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