APR March 2024 - 35
Integrated systems such as our MAS-100 Iso MH® sampler have multiple heads and can
pull the gaseous VHP through the heads during a decontamination cycle, so there is
no need to remove the heads for autoclaving. A single control unit can handle up to
four sampling locations, and there are also various interfaces to allow direct control
of the system via an isolator panel. If, instead, a portable sampler is used and moved
from a lowergrade area to an isolator, it is important to address the risk of carrying over
contaminants that remain within the instrument. An integrated exhaust HEPA filter can
protect the processing environment against this risk.
Is the contamination risk of transfers reflected in the locations
to be monitored?
Anne Weeks: Yes, this is usually the case. The monitoring areas result from the risk
assessment that must be performed. For air monitoring, these locations are typically the
entry and exit points of materials as well as the position where the product is filled and
thus exposed to the environment. The surfaces to monitor are usually the gloves and
other areas for which an elevated contamination risk has been established. This must
take into account the operator's ability to physically reach the surface to be sampled
without contaminating the area.
Kristian Siedler: For difficult-to-access sampling locations such as equipment recesses
and nooks, but also tubing and filling needles, swabs that generate a clear yes/no result
have proved the ideal tool. To minimize false positives, they should be designed to
avoid unnecessary handling steps before and after sampling. Our ICR swab carries its
own sterile growth medium and therefore has to be opened only once. Only after it has
been closed again does its medium come into contact with the pre-moistened swab tip.
ICR swabs are triple-bagged to enable safe transfer into isolators.
What about taking materials out of the isolator?
Anne Weeks: The removal of materials, for example environmental samples or waste,
should be carried out in a unidirectional process that is separate from the entry route.
If not possible, time-based separation of incoming and outgoing materials can be an
option, along with controls applied to avoid isolator contamination. What sometimes
gets too little consideration is the safe handling and removal of the culture media after
sampling. Lockable plates as well as the sterile transfer bags included in our IsoBag® can
help avoid external contamination and false-positive test results.
Find out how the IsoBag® rapid transfer bags containing packs
of ICR/ICRplus contact and settle plates support safe and
efficient aseptic processing in isolators.
www.sigmaaldrich.com/isobags
IsoBag™
Save time and
increase flexibility
Transfer media
plates into your
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SigmaAldrich.com/
isobags
MilliporeSigma is the U.S. and Canada
Life Science business of Merck KGaA,
Darmstadt, Germany.
© 2024 Merck KGaA, Darmstadt, Germany and/or its affiliates.
All Rights Reserved. MillipreSigma, the vibrant M, Millipore,
and IsoBag are trademarks of Merck KGaA, Darmstadt,
Germany or its affiliates. All other trademarks are
the property of their respective owners.
54008 | 02/2024
www.americanpharmaceuticalreview.com |
| 35
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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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