Page 10 - GMP-PharmaCongress 2024

GMP–
PHARMA
CONGRESS

The role of RDSs in and checked for intactness and transfer them through the Beta
contamination control then securely placed into a sealed containers into filling isolators.
sample bag for further incubation.
The use of RDSs for material transfer These bags can be transferred to Conclusion
into filling lines ensures sterility as- the microbiological laboratory for
surance levels according to EU An- incubation and evaluation. The pharmaceutical industry ad-
nex 1 standards. The qualified, auto- • Storage of materials within the heres to strict regulatory standards,
mated decontamination systems RDS: The space within the RDS can particularly in the area of contami-
have an advantage over operator- be used as a Grade A storage area nation control, which is fundamen-
dependent (subjectivity) manual to maximize efficiency by provid- tal to ensuring the safety and in-
wipe-spray transfer techniques. ing immediate access to deconta- tegrity of sterile medicinal products.
These are widely recognized as one minated materials. To ensure full The compliance landscape, such as
of the weakest operations in the compliance with EU GMP Annex 1, the EU GMP Annex 1, highlights the
aseptic transfer process. In addition, the air velocity, humidity, and critical role of CCS in pharmaceuti-
many objects are too massive, small, temperature within the chamber cal manufacturing.
uneven with their surface struc- are monitored by a sensor. This As the pharmaceutical industry
tures, or there are simply too many dedicated space ensures that continues to evolve, the versatile
items for an operator to process stored items remain in a state of and adaptable nature of RDSs is
consistently with manual disinfec- controlled sterility. By housing es- proving to be a valuable asset in
tion/decontamination practices. sential materials such as monitor- meeting regulatory standards and
• Transfer of materials from RDS to ing tools and format parts within maintaining the integrity of sterile
the filling line: Transferring mate- the RDS, pharmaceutical facilities drug products. RDSs support sterility
rials into the filling line is a critical can optimize workflow and mini- assurance and operational efficiency
aspect of contamination control. mize delays in production pro- by reducing the risk of contamina-
A RDS ensures comprehensive de- cesses. This strategic use of space tion during material transfers, parti-
contamination and aseptic transi- not only maintains sterility during cularly into Grade A environments.
tion of various items, maintaining storage but can also be used as an The practical application and
sterility during their passage to additional handling area, allowing functionality of RDSs within manu-
the filling line. Especially during for all types of dual glove-assisted facturing processes demonstrates
campaign filling scenarios, the use handling with proven integrity. their potential to enhance existing
of a RDS can support safety and • RDS during corrective interven- transfer and contamination control
efficient transfer of materials into tions: Corrective interventions methods through the use of auto-
filling isolators. RDSs find special- may be required during batch mation. Robust automated mea-
ized use in the transfer of environ- processing in rare scenarios. A sures ensure that sterility is main-
mental monitoring materials. corrective intervention is an in- tained. RDSs provide benefits for
• Transfer of materials from the fill- tervention performed to correct material transfer into filling lines,
ing line isolator to the RDS: For or adjust an aseptic process such as reducing gassing cycles,
larger batches and media fills, it is during its execution. Examples in- optimizing isolator space, and
also important to consider the clude clearing component jams, handling a wide range of materials,
transfer of materials such as en- stopping leaks, adjusting sensors, including those sensitive to tem-
vironmental monitoring plates and replacing equipment [1]. The perature fluctuations.
from the filling line isolator to the use of an RDS can assist when
quality control laboratory. Ex- troubleshooting is required on the Literature
posed environmental monitoring filling line and when spare or re-
plates must be incubated within a placeable parts are needed on the [1] European Union (2022). EudraLex – Vol-
ume 4 – Good Manufacturing Practice
specified time and therefore exit filling line. Using an RDS during (GMP) guidelines: Annex 1: Manufacture
the Grade A area in a secure man- this corrective intervention or de- of Sterile Medicinal Products.
ner. The RDS plays a critical role in viation can reduce the need to [2] Pharmaceutical and Healthcare Sciences
Society (2023). Contamination Control
contamination control during this stop the batch and open the iso- Strategy Guidance. Swindon, UK: PHSS;
process. The exposed plates are lator. RDSs can be used to decon- June 2023.
transferred aseptically from the taminate and transfer spare parts [3] Pharmaceutical and Healthcare Sciences
Society Bio-contamination Special Inter-
filling line isolator through Beta that need to be sent to the filling est Group. Bio-contamination Technical
ports back into the RDS chamber, line isolator. In addition, RDSs can Monograph No. 20: Bio-contamination
which has been previously decon- be used to decontaminate the ex- Characterisation, Control, Monitoring,
and Deviation Management in Con-
taminated and is integral. These ternal surface of previously ster-
trolled/GMP Classified Areas, Swindon,
plates are appropriately arranged ilized packaged materials and UK: PHSS; Sept. 2014.

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