APR March 2024 - 34

QC CORNER
Enhancing Material and Equipment
Availability in Production Isolators
Anne Weeks
Commercial Applications Specialist BioMonitoring
MilliporeSigma; Burlington; MA; USA
An affiliate of Merck, KGaA Darmstadt, Germany
Using isolators for aseptic processing is fast becoming
standard practice in the pharmaceutical industry.
However, it is a well-known fact that the transfer of
equipment and materials into and out of RABS and
isolators is one of the greatest sources of contamination.
This is why new regulation is being put into place to
mitigate the risk. Anne Weeks and Kristian Siedler, two
experts in environmental monitoring, discuss how
manufacturers can reconcile contamination safety and
processing efficiency.
How does the recently revised EU GMP
Annex 1 approach the contamination
challenge of transfers?
Kristian Siedler: Manufacturers have to implement a
holistic contamination control strategy that helps them
to understand their process. It has to cover the entire
manufacturing chain in the facility and be based on a risk
assessment. This includes preparing documentation that
describes the contamination risk management strategy
and how the demanded continuous improvements
and investment plans to prevent contamination will
be managed. Specifically, the risks of any activities that
might compromise cleanliness must be assessed, and this
includes the transfer of materials and equipment into and
out of isolators.
Anne Weeks: Ideally, transfers into an isolator should
be carried out in a one-way process and sterilization
performed using a double-ended autoclave. Where
this is not possible, a procedure that achieves the
same objective of avoiding contamination must be
Kristian Siedler
Global Product Manager
Commercial Excellence BioMonitoring
Merck KGaA, Darmstadt, Germany
validated and implemented. All airlocks should ensure
physical separation and minimize microbial and particle
contamination between areas. The final stage of an
airlock must, when at rest, be of the same cleanliness
grade as the area to which it gives access. However,
after decontamination and during processing, transfers
of materials into isolators should be minimized and
preferably supported by rapid transfer technologies or
transfer isolators.
How can you reduce the transfer of
materials when there is preciously
little storage space in your isolator?
Anne Weeks: It is possible to mount a transfer bag
containing packs of contact or settle plates to the 190
mm alpha port of your isolator. There is no need to
decontaminate the packs of plates, so the number of
necessary decontamination cycles and the volume
needed for surface contact is reduced. This enables
longer periods of uninterrupted production and frees
up valuable space, which is particularly useful for
manufacturing campaigns lasting several days. These
bags retain their integrity for multiple connections to the
alpha port, so are highly flexible. Our gamma-irradiated
IsoBag® DPTE rapid transfer bags can each hold up to 80
ready-to-use ICR settle or 100 contact plates for air and
surface monitoring.
Kristian Siedler: It is also possible to use dedicated active
air samplers like the MAS-100 Iso line of instruments
where the control unit is positioned outside the isolator,
with only the sampling heads needing to be inside.
34 |
| March 2024

APR March 2024

Table of Contents for the Digital Edition of APR March 2024

Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
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