Early drug development is increasingly important, and FPS supports that activity by offering new custom solutions that fit the specific needs of the Pharmaceutical, Biotech and Fine Chemical sectors.
These machines are installed in research laboratories and/or pilot production plants, to ensure safe handling of active substances in a contained environment.
When you must prevent external contamination during all potent powder handling activities and to ensure the safety of the operator from the potent substances. In the study of new drugs, it happens often that during the chemical reaction phase, intermediates are created. The issue is that, at that stage, their toxicity and their potential averse effects are unknown. Using a barrier isolator will prevent the operator exposure to this compound.
The type of containment system is determined by the quantity of product handled, by the OEL “occupation exposure limit” which is expressed in μg/m3, by the chemical/physical characteristics of the substances and by the type of activities performed inside the isolator.
First, compared to any other system, an Isolator is designed to guarantee a perfect separation between the working area and the surrounding environment. An isolator, working under a pressure differential regime, guarantees an additional barrier to avoid contamination. Using an isolator, the operator can work without a breathing device, a protective mask or any other cumbersome PPE (Personal Protective Equipment). Also the ergonomics are greatly improved with an isolator and the operator safety is significantly increased.
Secondly, another way to ensure operator safety is the safe filter change feature. And after the filter change the contaminated HEPA filter can be safely removed through a Bag-In Bag-Out port.
A third benefit is that an isolator can guarantee a low level of moisture or a low oxygen level inside the working chamber, this is crucial for some sensitive products.
And here are some example of applications for which FPS designed tailor-made solutions:
Contact us and define together with us your suitable configuration to your needs