Pharmaceutical Isolators and Passive RABS

Active and Passive Pharmaceutical Isolators with Positive or Negative Pressure

Pharmaceutical isolators and RABS are devices designed to protect the product during handling and the operator when processing potentially hazardous active ingredients. Isolators and RABS are two distinct technologies.

Pharmaceutical Isolators

Isolators are devices equipped with an air treatment system that allows work to be carried out in a confined and controlled environment. They offer maximum safety for the product, operators and the environment.

RABS (or Restricted Access Barrier Systems)

RABS, or Restricted Access Barrier Systems, are a barrier technology with a fixed, rigid partition separating the operator area from the critical process area. Unlike isolators, RABS do not provide a perfect seal. Furthermore, they do not have a gas decontamination system.

It should be noted that pharmaceutical isolators and passive or active RABS can be active or passive flow systems. They are equipped with transfer systems for introducing consumables and equipment.

Open and Closed RABS Systems for Pharmaceutical Isolation

There are two types of restricted access barrier systems (RABS): open RABS and closed RABS.

Open RABS

First, there are open RABS, also known as Open RABS, which are restricted access barrier systems with doors that can be opened to facilitate operator intervention during aseptic production activities. Open RABS are available in active and passive versions.

• Passive RABS do not have their own air filtration and treatment system. This means that the air flows outside, into the production area. The air purity in passive open RABS depends on that of the clean room. This model is suitable for the processing and handling of non-toxic products.
• The active open RABS, on the other hand, has its own air supply and recirculation system. As this model offers a high level of containment, it is ideal for processing and handling highly active or cytotoxic products.

Closed RABS

In addition to the open RABS, there is also the closed RABS, also known as the closed RABS. It has the special feature of being equipped with a laminar flow system, ventilation and filtration units. Thanks to its HEPA (High Efficiency Particulate Air) filtration system, the air quality in the enclosure is guaranteed. In addition, this restricted access barrier system is equipped with tempered glass doors, which can be closed completely to ensure reliable separation. Its features can be customised. EREA can equip it with RTP systems, interlocking access doors, or glove ports.

Comparison and Choice Between Pharmaceutical Isolators and RABS for Specific Applications

In the pharmaceutical industry, the choice between pharmaceutical isolators and RABS depends in most cases on the specific requirements of each application. Each of these solutions has advantages and disadvantages that must be carefully evaluated to ensure the safety and efficiency of production processes.

The Characteristics of Pharmaceutical Isolators

Pharmaceutical isolators offer a high level of protection by completely confining the product inside the enclosure. This significantly reduces the risk of cross-contamination while ensuring maximum sterility. This makes them an ideal choice for sensitive products or operations requiring a highly controlled environment.

However, these isolators can be expensive to install and maintain. In addition, they may be less flexible to use than RABS systems.

Specific features of RABS

RABS, on the other hand, offer partial protection by creating a physical barrier between the operator and the production area, while allowing a certain degree of flexibility in operations. They are generally less expensive to set up and can be more easily integrated into existing facilities. The downside is that RABS systems present a higher risk of cross-contamination compared to pharmaceutical isolators, as they do not completely enclose the product.

Criteria for Choosing Between the Two Solutions

The choice between pharmaceutical isolators and RABS depends on several factors, such as product sensitivity, sterility requirements, budget constraints and specific operational needs.

For pharmaceutical products requiring absolute sterility and maximum protection against contamination, the first option is preferable. However, for less sensitive products or operations where flexibility and productivity are priorities, RABS systems may be suitable.

EREA Pharma, your Designer and Supplier of Containment Solutions

For your pharmaceutical isolator and passive RABS installation project, call on EREA Pharma. We are a company specialising in the manufacture of containment solutions. Our products are reliable and customisable and comply with the requirements of current standards and regulations, including Good Manufacturing Practices. EREA designs and manufactures customised isolators and restricted access barrier systems. We can offer you open or closed flow RABS, closed RABS, etc. By choosing EREA, you will benefit from the support of a competent and qualified team.

Get a free quote via our website by contacting us.