Page 6 - GMP-PharmaCongress 2024

GMP–
PHARMA
CONGRESS

Enhancing Contamination Control

in Pharmaceutical Manufacturing

with a Rapid Decontamination

Station

Dr. Birte Scharf l Franz Ziel GmbH, Billerbeck
Varadharaj Vijayakumar l WuXi Biologics Germany GmbH, Leverkusen

Correspondence: Dr. Birte Scharf, Franz Ziel GmbH, Raiffeisenstr. 33, 48727 Billerbeck;
Birte.Scharf@ziel-gmbh.com

Abstract Key Words

The pharmaceutical industry operates under strict regulatory standards • Decontamination
to ensure the safety and quality of sterile drug products. European • Contamination control
Union Good Manufacturing Practice (EU GMP) Annex 1 requires the • Material transfer
development of a Contamination Control Strategy (CCS) based on • Aseptic manufacturing
a scientific assessment to understand the process and apply risk
management principles. An important aspect of contamination control
is the transfer of materials, particularly into Grade A areas.
This article examines the role of stand-alone Rapid Decontamination
Stations (RDS) in contamination control. It also describes the use of
RDSs to decontaminate materials and transfer them to filling line
isolators. In addition, insights from manufacturing applications are
provided for both material transfers to and from filling isolators.
RDSs are aligned with evolving regulatory standards, optimised loading
configurations, and stringent cycle design criteria ensure effective
decontamination. Automated controls ensure sterility, resulting in
safety and efficient material transfer.

Introduction development of a comprehensive grade A or B areas should be car-
Contamination Control Strategy ried out via an unidirectional pro-
Good Manufacturing Practice (CCS) is essential for manufacturing. cess. Where possible, items should
(GMP) regulations for the pharma- Material transfer – particularly into be sterilized […]. Where steriliza-
ceutical industry ensure the safety Grade A/ISO 14644 class 5 areas – is tion upon transfer of the items is
and quality of sterile medicinal critical for maintaining contamina- not possible, a procedure which
products. One of the key documents tion control within the broader achieves the same objective of not
governing the manufacture of scope of a CCS [2]. introducing contamination should
sterile medicinal products is the There are several options for be validated and implemented,
European Union Good Manufactur- aseptic transfer in Grade A environ- (e.g., using an effective transfer
ing Practice (EU GMP) Annex 1 [1]. ments, each with its own set of ad- disinfection process, rapid transfer
In its revised form, Annex 1 intro- vantages and limitations. EU GMP systems for isolators or, for gas-
duces new guidance with a particu- Annex 1 states in chapter 4.11: eous or liquid materials, a Bacter-
lar emphasis on quality by design “The transfer of materials, equip- ia-retentive filter). The removal of
and quality risk management. The ment, and components into the items from the grade A and B

4 | PharmaCongress 2024