RABS TYPE ISOLATOR : A NEW GENERATION ISOLATOR SIGNED SERAC
15 June 2006 - Serac

The RABS isolator represents a significant improvement in the aseptic filling sector.
It optimizes the aseptic conditions in and around the sterile enclosure. It offers the operator more freedom and comfort in the accomplishment of his tasks.
It extends production times by extending the period during which the aseptic
conditions are maintained.

Over a period of 35 years, the company has established itself as the specialist and
leader on the aseptic filling market with its first line installed in 1978. It is for this
reason that leading milk and drinks filling companies worldwide place their trust in
us.

Serac has submitted around 80 patents in the filling sector. In January 2005 it
submitted a patent entitled: "Aseptic filling machine with aseptic barriers". This
patent protects the design of a new generation isolator referred to as RABS type
isolator.

Several years ago the pharmaceutical industry developed a new type of isolator
known as Restricted Access Barrier System. The traditional isolator has several major shortcomings : low air renewal rate in the enclosure, turbulent and uncontrolled airflow, difficulty to check sealing quality. In the pharmaceutical industry, these shortcomings justified the development of the RABS type isolator and it is this same standpoint that led Serac to design its own.

The ISPE (International Society for Pharmaceutical Engineering) defined the
RABS type isolator for the FDA according to 7 criteria.

The 7 criteria defining the RABS isolator are:
1) - Solid partition providing a physical separation between production and the
operators
2) - Unidirectional airflow - ISO 5
3) - Glove boxes or automation system to avoid access during filling
4) - Equipment transfer system to avoid exposure to less clean environments
5) - High level of surface disinfecting
6) - ISO 7 environment class
7) - Very few interventions, required :
- one decontamination after intervention
- doors latched and monitored
- Positive pressurization
- ISO 5 environment class

Serac strictly adhered to these definitions when developing its RABS isolator
The well-known advantages offers by the traditional isolator have been
retained.

The operator, primary source of contamination, controls the machine from the
outside and the overpressure created inside the sterile zone prevents any risk of
contamination.

Serac proposes 3 major improvements to the traditional isolator:
Unidirectional airflow
Barrier zones
Easy access

Unidirectional airflow :
Contrary to the traditional isolator, the RABS isolator is not hermetically sealed.
The system is composed of an air barrier which generates a positive overpressure
inside the enclosure to protect the sterile work zone.
A vertical unidirectional flow at a controlled speed enables continuous circulation
and renewal of the air.

Association of these two techniques offers dynamic protection of the sterile
enclosure and enables both elimination of possible particles present inside the
enclosure and protection against the penetration of contaminants from the
outside.

Constant air circulation avoids confinement, extends the aseptic state time and
enables production over long periods without the need for intermediate
decontamination.

http://www.serac-usa.com

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