Physical and hermetic barrier between the operator and the product
cRABS - Closed Restricted Access Barrier System
A physical and hermetic barrier between the operator and the product. The air is recirculated through dedicated return air ductwork in a sealed chamber.
The system allows working at pressure differentials (upper / lower) to the surrounding environment, and monitors and controls the processing parameters (V, P, T, Hr, etc.).
The line must operate in a clean room grade B or higher.
Due to the growing concern for product and operator protection and the complex regulatory framework of the pharmaceutical industry, it became essential to design the processing equipment together with the containment system.
Aseptic pharmaceutical manufacturing requires the production area to be free from microbiological and particle contamination. The environmental conditions for sterile processing are designed to maintain product sterility and are ISO 5 or Grade A classified, considering the following parameters:
Particle level (> 0.5 μm) less than 3,520 particles/m3.
Vertical air flow laminarity.
Cleaning and decontamination procedures.
In accordance with these standards, Dara Pharma has developed a wide range of products for different environmental conditions and levels of protection: