Page 9 - GMP-PharmaCongress 2024

are filled in the filling isolator and be used to decontaminate various transferred in-time and -place.
cycle end points of ≤100 ppb kinds of materials and even tem- Furthermore, materials from the
H 2 O 2 are therefore required. Many perature-sensitive materials, like filling line can be transferred to
plastic materials are known to agar plates for environmental the RDS, ensuring safety handing
outgas and extend the aeration monitoring. over of the environmental moni-
time. Materials can be gassed in • Campaign filling scenarios: RDSs toring plates to the incubators.
the RDS independently of the can play a crucial role in campaign Application of RDSs can enhance
gassing cycle of the isolator (e.g., filling, ensuring that materials ne- contamination control strategies
during the setup process of the cessary during the manufacturing and streamline manufacturing pro-
filling isolator) and transferred process are decontaminated and cesses.
once the target con-
centration has been
reached.
• Optimization of isola- Seminar
tor space: By reducing
the need to store ma- WASSERSTOFFPEROXID
terials such as moni-
toring materials, BIO-DEKONTAMINATION
cleaning materials,
and tools within isola- Die Seminarthemen:
tors, the RDS contri-
butes to the efficient Neuer H 2O 2 MAK-Grenzwert 0,5 ppm
use of space within
manufacturing facil- Biozid- und Gefahrstoffverordnung
ities. Room inside the Mobile und stationäre VHP -Generatoren
®
RDS can be used as
storage or handling Labor- & Reinraum-Dekontamination
space under Grade A Isolatoren und Materialschleusen
conditions. If materi-
als are needed, they Mikrobiologie
can immediately be
Materialverträglichkeit
transferred to the
designated position.
• Advantage over RDHs:
Transfer is possible at
any point where an
RTP is installed/lo-
cated. This contrasts
with the RDH, which
is fixed at one point
and from which mate-
rials may have to be
passed through the
entire filling line if Kommen Sie gern zum nächsten 2-tägigen
they are needed at the VHP-Seminar in Berlin vom 17.-18. April 2024
other end. Gassing in
the RDS is time-inde- Programm-Anfragen: Gerhard_Lauth@outlook.de
pendent from the gas-
sing of the filling line,
while the hatch must
be gassed during the
initial cycle of the fill-
ing line.
• Advantage over auto-
claving and transfer:
In the RDS, vH 2 O 2 can