Sterile

Open and Closed RABS by EREA Pharma – Safety First

EREA designs and manufactures RABS for aseptic environments. They provide strict product protection, eliminating airborne contamination and contamination by operators.
Open and Closed RABS by EREA Pharma – Safety First

Overview

Photos

Features
OPEN RABS
CLOSED RABS

RABS - Restricted-Access Barrier System by EREA Pharma

  • Tailor-made ergonomic design
  • Cleanliness class: A class (Iso 5)
  • Tightness class: 3 or 2
  • Flow equipment: unidirectional (laminar) vertical
  • Regulation: temperature, pressure, excess pressure, humidity

Customised Technical Solution

Static and Dynamic Protection

Quick Installation and Implementation

Easy-to-clean Surface

Features

  • Machine safety
  • Containment
  • Flexibility for all line and cleanroom configurations
  • Traceability of operations and door openings
  • Ergonomic design
  • Creation of customised accessories
  • 100% made-to-measure
  • HMI integration
  • Safety loop & information loop
  • Supervision
  • Automation
  • Batch reporting
  • Audit Trail (21 CFR part 11 standard)
  • 1:1 mock-up on site or at EREA
  • Mock-up production
  • Aeraulic simulation
  • In accordance with GMP Annex 1

OPEN RABS

OPEN RABS is an intermediate solution between full protection and direct access, combining controlled airflow with a partial physical barrier to protect critical areas while allowing easier operator intervention.

Open RABS – Passive

  • Passive flow: Customer supply air ceiling (FLV)
  • Exhaust air zone at lower level
  • Physical barrier with high-visibility PETG doors
  • Interlocking doors: enhanced safety
  • No differential pressure
  • Can only be used on non-toxic products
  • Audit Trail
  • Possibly ATEX

Open RABS – Active

  • Active flow: Unidirectional (laminar) flow integrated into the RABS, also covering the doors
  • Air exhaust area at the bottom
  • Physical barrier with high-visibility PETG doors
  • Interlocking doors: enhanced safety
  • No pressure differential
  • Can be used on non-toxic products only
  • Audit Trail
  • Possibly ATEX

CLOSED RABS

CLOSED RABS is positioned between open RABS systems and isolators, offering a more flexible option than an isolator while being more secure than an open RABS. Closed-RABS offers a totally enclosed environment with a higher level of protection against contamination with restrictions on direct human interaction.

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The RABS, Restricted Access Barrier System, is a barrier technology that appeared in the 1990’s to separate personnel from the product, retain contaminants or segregate two areas. RABS allow to reduce or eliminate interventions in the critical area by installing rigid separations. Pharmaceutical industries can choose between open (active or passive) and closed RABS.

The latter is characterized by a closed system so that the product or material is not exposed to the environment of the room. It has a Class A (ISO 4.8) air quality unit and offers continuous and seamless isolation.

EREA RABS

EREA offers solutions adapted to the needs and requirements of the pharmaceutical industry. Our range of RABS ensures protection of the product, the operators and the environment. Containment is respected, while bringing flexibility to your line and clean room configurations. The traceability of interventions and door openings are guaranteed. EREA offers three types of RABS: open RABS – passive; open RABS – active and closed RABS.

Open RABS

Open RABS with passive flow

The Open RABS with passive flow is characterized by an air supply that is dependent on the surrounding cleanroom filtration system (customer’s fan ceiling (FLV)). It has an air exhaust at the bottom. It is equipped with PETG doors with excellent visibility, and thanks to the interlocking of the doors, ERA guarantees increased safety for all your processes. The Open RABS with passive flow can be used for non-toxic products.

Open RABS with active flow

The Open RABS with passive flow is characterized by a HEPA-filtered air supply via its own filter station, integrated in the equipment. A laminar flow is integrated into the RABS, also covering the doors. EREA’s Open RABS with active flow also has an exhaust air zone at the bottom. It has PETG doors with excellent visibility that can be interlocked. The Open RABS with active flow can be used on non-toxic products.

The Closed RABS

The Closed RABS is a closed system with a hermetically sealed chamber with its own air supply and recirculation. It is used for highly active and cytotoxic products. Their design makes them similar to isolators.

Closed RABS with active flow

EREA’s Closed RABS with active flow incorporates a laminar flow, also covering the doors. It has on-board filtration/ventilation units. It is therefore able to provide HEPA, or High Efficiency Particulate Air, filtered air to the critical process before it is recirculated. As a physical barrier, it is equipped with tempered glass doors that guarantee a complete closure for enhanced safety.

It offers a negative or positive differential pressure, managed by an automaton.

It is designed for multipurpose use, i.e. sterile and toxic. All RABS closed systems can include glove ports, access doors with interlocks, RTP systems as well as EM systems.

EREA: a Unique Know-how at Your Side

EREA has 2,500 m2 of workshop space, a highly specialized team, airflow simulation and 3D visualization software. Thanks to our clean room, EREA can carry out full-scale ergonomic tests. All our equipment is manufactured in France according to strict protocols.

EREA installs its containment systems all over the world and ensures their qualification. We take particular care to develop integrated solutions adapted to your needs. The EREA teams are at your service to answer all your questions.

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