Page 73 - Assurance of Sterility for Sensitive Combination Products and Materials

Aseptic processing 59

Fig. 4.3 Smoke in airflow profile study. (Courtesy of ivtnetwork.com)

4.17 Isolators, RABS, BFS, and other advanced aseptic
barrier systems

The use of barrier systems to protect sterilized product and product contact
surfaces from the environment and personnel is an effective means to pre-
vent microbiological contamination.
Isolators or barrier isolators are generally closed or partially closed sys-
tems containing component handling, conveying, filling, and sealing systems.
Isolators are typically decontaminated using gases such as vapor phase hy-
drogen peroxide, peracetic acid, or other chemical means. Access in and out
of isolators is strictly controlled. Isolators are not opened during operation,
and personnel access is limited through decontaminated glove ports. The
access through glove ports enables the reduction of gowning requirements
for personnel. Environmental monitoring takes place within the isolators in
a similar manner as would be the case with non-isolator open systems. The
interior of Isolators is typically designed to be Grade A or ISO 5 and the
Isolator itself may be placed in a less controlled area—Grade C or D.
RABS (restricted access barrier systems) are partially closed systems,
where the interior is designed to be Grade A or ISO 5 and the RABS is
placed in a Grade B area. Personnel access the interior through decontami-
nated glove ports; however, personnel are typically gowned. The interior of
the RABS may be disinfected with a chemical wipe down or decontami-
nated through fumigation. Restricted access means that there should be no
access during aseptic operations.