Long before planning a Containment production plant that is used in a pharmaceutical environment the threshold values of the Containment to be achieved need to be defined very precisely in order to determine either a primary or a secondary Containment System. At this point the main focus should be on a primary Containment, whereas the secondary should function as a supplementary security measure.
OEB-values or OEL-levels have a significant influence on the selected Containment
System. To define this value an accurate risk analysis with special measuring devices is necessary, followed by an analytical evaluation in a certified laboratory.
There are various factors to consider before planning a Containment System.
The production quantities processed by the customer as well as the product changeover frequency are crucial factors for the decision on a mono- or multifunctional system or the automation level of the machinery. Another essential point is the full compliance with all current standards and guidelines.
Furthermore, all process interfaces and actions performed by the operator are important aspects that should be considered carefully. In addition, the fluidity and characteristics of the product have to be evaluated. Depending on the product, explosion protection must be guaranteed.
Planning of the system has to be performed from the inside to the outside and requires extensive knowledge of the respective processes and their weak points. These can be found, for instance, in dosing systems, valves or within the exhaust air system and filter units.
In order to avoid cross-contamination, product contamination and product spreading, an optimum cleaning capability of the machinery is of particular importance. In this case supplementary systems with WIP-, CIP– or DIP-cleaning methods are recommended but of course the process needs to be evaluated in advance. A subsequent installation always involves unnecessary high costs.
One more crucial point is maintenance and servicing of the Containment System. Depending on the kind of system, an opening of the processing unit will be necessary but can only be performed after a successful cleaning. A regular monitoring and maintenance are mandatory. By wettening the surfaces, dust emission and leakage can be avoided.