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De Nition of Restricted Access Barrier Systems
De Nition of Restricted Access Barrier Systems
INTRODUCTION
RABS—restricted access barrier systems—were developed to advance the aseptic processes that
were previously carried out in conventional clean rooms.
Traditionally, the protection of product from contamination by the operator was achieved
by putting the filling equipment under laminar airflow units. Manual interventions, operators
operating directly over open product, uncontrolled airflow patterns and frequent sterility test
failures, and media fill failures were common then.
It was widely acknowledged that the concept of isolators for aseptic filling was nearly
immediately understandable, while the design concepts and ways of operation for RABS
were somewhat more difficult to understand. Several attempts were made to exactly define
RABS, some of them creating perhaps more confusion than actually helping to understand the
technology.
In 2005, triggered by a request from the US Food and Drug Administration, a group
of industrial professionals within ISPE (International Society of Pharmaceutical Engineering)
worked out a concise definition of RABS (1). The main building blocks of this definition were
the following:
The open-door interventions need to be under a defined protocol with line cleaning/line
clearance and local sanitization. The appropriate documentation for this intervention is also
mandatory. When this definition was published, the debate continued on the inclusion of “rare
open-door interventions.” This was seen as a way out of proper aseptic technology, allowing
for inclusion of bad practices.
In this chapter, an attempt is made to define the different variants of RABS in a more
appropriate manner.
HEPA filters
3–6" From
HEPAS
Filling
Class 10,000 Class 100 mechanism
(ISO 7) (ISO 5)
Nozzle
Vial
Conveyor
Figure 1 RABS (Passive) Restricted Access Barrier System. Source: From Ref. 2.
HEPA
HVAC
HEPA filters
Class Filling
Class 100 mechanism
10,000
(ISO 5)
(ISO 7)
Nozzle
Vial
Conveyor
Figure 2 RABS (Active) Restricted Access Barrier System. Source: From Ref. 2.
c08 IHBK069-Agalloco June 21, 2010 12:53 Trim: 10in× 7in
Closed RABS
HEPA
HEPA Filters
Class Filling
10,000 mechanism
(ISO 7)
Nozzle
Vial
Conveyor
Air
return
Figure 3 RABS (Closed) Restricted Access Barrier System. Source: From Ref. 2.
Operation of a RABS
All of the above-mentioned RABS variants can be operated as a best-practice RABS
where open-door interventions are strictly prohibited. When this is combined with frequent
high-level disinfection, proper aseptic technique and monitoring, a very safe and robust pro-
cess is achieved.
CONCLUSIONS
As always, product requirements, dosage forms, and economic considerations have to be aligned
when a new filling room is designed. Following the original ISPE–RABS definition and combin-
ing it with the simple distinctions between active/passive and open/closed RABS, one should
easily come to the right conclusions as the design and operation of RABS.
REFERENCES
1. Lysfjord J, et al. Restricted access barrier system (RABS) for aseptic processing. Pharm Eng 2005;
25(6):116–117, 120.
2. Lysfjord J. Aseptic Processing: Advancements in Manufacturing—RABS & Isolators. PDA Conference
on Risk Management, Bethesda, MD, May 15–16, 2008.