Page 8 - GMP-PharmaCongress 2024

GMP–
PHARMA
CONGRESS

tainers are then connected in the
Alpha port of the isolator filling
lines for the transfer of required de-
contaminated materials to support
various manufacturing stages. The
transfer from Beta containers fol-
lowing the decontamination cycle
from the RDS to the filling line iso-
lator is crucial, with proper instal-
lation of the Beta port being a key.
While a faulty Alpha/Beta port con-
nection theoretically poses a risk to
aseptic conditions, the design of the
port aims to prevent such issues and
to minimize any risk to the isolator's
Figure 1: Schematic view of a stand-alone rapid decontamination integrity. Careful decontamination
station (RDS) with installed beta containers (white) (all figures and monitoring of Beta containers
provided by Franz Ziel GmbH).
in the RDS ensure their appropriate
state for item placement, making
connections through the Alpha/
Beta port post-decontamination un-
likely to contribute to contamina-
tion.
The benefits of using a RDS to
support filling within an isolator are
as follows:
• Sterility assurance through auto-
mated controls: The chamber in-
tegrity is confirmed through
automated leak testing. Auto-
mated glove testing systems are
used to proof glove integrity
testing. During decontamination,
automated checks of glove ex-
tender placement and controlled
container opening protocols al-
low for full surface decontami-
nation. The air velocity in the
chamber is monitored by a sen-
Figure 2: RDS chamber loaded with materials for surface decontamination. Loads are sor inside the chamber to ensure
hanging for appropriate surface decontamination and distribution of vH O .
2 2 full compliance to EU GMP An-
nex 1. Thus, foolproof automated
measures ensure Grade A condi-
croorganisms protected by a shield- quires stringent criteria for cycle tions inside the chamber are
ed surface or covered by machine development and qualification. This maintained.
surfaces. Therefore, hanging the involves precise control of key para- • Reduced initial gassing cycle: Use
items in the chamber rather than meters like temperature, humidity, of a RDS leads to the reduction of
laying them flat allows for more ef- vH 2 O 2 concentration, and contact necessary material placement
fective distribution of the vapours time. In addition, the load config- within initial gassing cycle of the
and decontamination (fig. 2). uration is essential, with defined filling isolator, so surface area and
Load items and internal surfaces maximum and minimum load limits outgassing are reduced. This ap-
of the Beta containers are deconta- for chamber loading [3]. proach saves time during the ini-
minated using a short vH 2 O 2 gassing After successful surface deconta- tial gassing process, thus reducing
cycle (cycle times under 45 min mination, the materials are trans- time to production and also costs.
achievable). Achieving a robust and ferred to Beta containers under This has a particular effect if oxi-
automated decontamination re- Grade A conditions. These Beta con- dation-sensitive pharmaceuticals

6 | PharmaCongress 2024