Protection and containment system
Wide range of products for different environmental conditions and levels of protection
Due to the growing concern for product and operator protection and complex regulatory framework of the pharmaceutical industry, it became essential to design the processing equipment together with its containment system.
The aseptic pharmaceutical manufacturing requires the production area free from microbiological and particle contamination.
In accordance with these standards, Dara Pharma has developed a wide range of products for different environmental conditions and levels of protection:
LAF - Laminar Air Flow
It is a dynamic barrier of HEPA-filtered unidirectional air flow to sweep particles away from the filling/closing area.
The line must operate in a clean room grade B or higher.
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 in and expelled directly into the room where the equipment operates.
The line must operate in a clean room grade B or higher.
cRABS - Closed Restricted Access Barrier System
A physical and hermetic barrier between the operator and the product. The air is recirculated through a dedicated return air ductwork in a sealed chamber.
The system allows working at different pressure levels (higher/lower) that the surrounding environment, and monitors and controls the system (H,P,T, Hr etc.).
The line must operate in a clean room grade B or higher.
Isolator / Moduline™
It is the highest available level of containment for both sterile and toxic products, equipped with a hermetic chamber, rapid transfer ports (RTP) and predefined action protocols. The system features a dedicated decontamination system (VHP), differential pressure adjustment, relative humidity & temperature control, particle sampling among other operating parameters. It allows operation in an ISO 8 or class D classified room.
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.
Humidity control.
Temperature control.
Air recirculation.
Cleaning and decontamination procedures.
ISO 14644-1 Cleanroom Standards
| Class | Particle max nº/m3 | FED STD 209 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ≥ 0.1 µm | ≥ 0.2 µm | ≥ 0.3 µm | ≥ 0.5 µm | ≥ 1 µm | ≥ 5 µm | ||||||||
| ISO 1 | 10 | 2.37 | 1.02 | 0.35 | 0.083 | 0.0029 | |||||||
| ISO 2 | 100 | 23.7 | 10.2 | 3.5 | 0.83 | 0.029 | |||||||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8.3 | 0.29 | Class 1 | ||||||
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | 2.9 | Class 10 | ||||||
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 | ||||||
| ISO 6 | 1.0 x 10⁶ | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1000 | ||||||
| ISO 7 | 1.0 x 10⁷ | 2.37 x 10⁶ | 1,020,000 | 352,000 | 83,200 | 2,930 | Class 10,000 | ||||||
| ISO 8 | 1.0 x 10⁸ | 2.37 x 10⁷ | 1.02 x 10⁷ | 3,520,000 | 832,000 | 29,300 | Class 100,000 | ||||||
| ISO 9 | 1.0 x 10⁸ | 2.37 x 10⁸ | 1.02 x 10⁸ | 35,200,000 | 8,320,000 | 293,000 | Room air | ||||||
We offer tailored solutions to each customer
Learn more about our complete lines