Access to the multimedia content of the products.

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:


Aseptic Lyophilization

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.


Freeze Drying System

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.


Laboratory Freeze Dryer

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.


Pharmaceutical Freeze Dryer

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

ClassParticle max nº/m3FED STD 209
≥ 0.1 µm≥ 0.2 µm≥ 0.3 µm≥ 0.5 µm≥ 1 µm≥ 5 µm
ISO 1102.371.020.350.0830.0029 
ISO 210023.710.23.50.830.029 
ISO 31,000237102358.30.29Class 1
ISO 410,0002,3701,020352832.9Class 10
ISO 5100,00023,70010,2003,52083229Class 100
ISO 61.0 x 10⁶237,000102,00035,2008,320293Class 1000
ISO 71.0 x 10⁷2.37 x 10⁶1,020,000352,00083,2002,930Class 10,000
ISO 81.0 x 10⁸2.37 x 10⁷1.02 x 10⁷3,520,000832,00029,300Class 100,000
ISO 91.0 x 10⁸2.37 x 10⁸1.02 x 10⁸35,200,0008,320,000293,000Room air

We offer tailored solutions to each customer

Learn more about our complete lines
Lyophilizer Suppliers