Physical barrier between the operator and the product in addition to the dynamic barrier of HEPA-filtered airflow (LAF)
ORABS - Open Restricted Access Barrier System
A physical barrier between the operator and the product in addition to the dynamic barrier of HEPA-filtered airflow (LAF), composed of a glass cabinet, gloves, transfer ports, etc.
The air is taken from and expelled directly into the room where the equipment operates.
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.