The concept of isolators is still a challenge for many pharmaceutical manufacturing companies, especially for sterile and toxic products, as their high investment cost is a barrier to their acquisition.
But is this really the case?
You would be surprised to know that, due to innovation, today this barrier is just a pharmaceutical legend and is also a sure bet for manufacturing quality assurance, and above all, and most surprisingly, for manufacturing cost-effectiveness.
From a quality assurance point of view, isolators provide a double barrier of protection for both the product and the environment. Higher degrees of sterility are achieved much more efficiently and, above all, are more easily maintained by avoiding contact with the most contaminating element, man. This allows lower product rejection rates, no false positives in sterility tests, which in turn is also an optimization in cost.
Process validation times are shortened, and results are fully reproducible over time, as there is much less human intervention. Reducing these times also means optimizing costs.
Operating costs are drastically reduced for several reasons. We no longer need a class A room to manufacture, it is enough to locate the isolator in a C room, which allows us to avoid special suits for A classification. With this we reduce entry times for operators in these rooms, cleaning and decontamination times of rooms directly impacting on time savings and therefore costs. By reducing the type, A classification areas, being the energy cost of a plant of these characteristics mainly due to the air conditioning system, energy consumption is also drastically reduced, and we are also favoring sustainability and the companies' commitment to CSR.
In terms of investment, we reduce the number of rooms needed to access the manufacturing area and therefore the space of the plant, which compensates, in many cases exceeds, the higher investment cost of the insulating equipment.
Therefore, the investment in an isolator is not only a barrier but becomes a great business opportunity for a pharmaceutical plant.