APR March 2024 - 15

« MICROBIOLOGY
preventive measure relies on the integrity and proper selection of the
gloves. Notably, nitrile gloves exhibit less elasticity compared to latex
or vinyl gloves. Vinyl gloves may also have lower resistance to alcohol
compared to latex.5
The process of donning sterile gloves, influenced
by the operator's skill, has the potential to introduce contamination.
It is crucial to emphasize that merely observing an operator wearing
gloves without assessing their glove management behavior leads to a
false sense of confidence. Glove management behavior encompasses
the operator's consistent disinfection of gloved hands, the use of a
reproducible disinfection technique, disinfecting before and after
use, and the regular changing of gloves after interventions. Wearing
gloves despite the hands being damp from either disinfectant or
handwashing is a common occurrence. Additionally, the operator
ensuring a consistent transition from dirtier to cleaner area while
simultaneously managing the operations task is very hard. This
behavioral-based glove-to-glove, glove-to-surface, and surface-toglove
cross-contamination potentials have been well established. The
glove disinfection stations/containers contaminated with pathogens
from improper usage can serve as an additional potential source.
Glove integrity can be breached by operators, introducing risks.
The primary source of contaminants in cleanrooms is personnel.6
Therefore, maintaining aseptic gowning practices is crucial for
controlling contamination and preventing the transmission of
microbes and bodily fluids during cleanroom activities. The behavior
of the operators and the integrity of the gown itself can pose
contamination risks. For example, after washing and irradiation,
reusable cleanroom apparel has been shown to significantly
degrade its Bacterial Filtration Efficiency (BFE).7
Human activities and
perspiration can contribute to contamination, making the length of
wearing a gown and individual operator physiology key variables
in addition to clean room temperature/RH conditions. Even with
cleanroom contamination controls, viable organisms and non-viable
particulates may persist in the cleanroom air and on various surfaces,
including walls and equipment, because of ongoing activities
(Figure 1). This contamination can transfer onto the operator's gown.
Contamination from particulates generated by humans can have
a considerable impact on the cleanliness of a cleanroom. Whether
stationary or walking, an individual dressed in cleanroom attire
can produce between 100,000 and 1,000,000 particles per minute.8
Hence, it is crucial to regulate the occupancy of a cleanroom.
Personnel following proper gowning practices, including good
personal hygiene, are essential to minimize contamination risks
in cleanroom environments. The management of pre-sterilized
materials, sterile components, environmental monitoring plates,
operational interventions, and various other factors influenced by
human behavior also has the potential for introducing contamination.
Established Industry Best Practices
Aseptic processing contamination has been attributed9
Figure 1. RABS Filling Line [Courtesy: Itaan Pharma]
Figure 2. Aseptic Processing Contamination Factors
adequacy of personnel practices during aseptic operations. Hence,
the industry has been developing and implementing best practices
specific to aseptic manufacturing operations.10-15
The best practices10
reiterate that theoretical knowledge is insufficient,
to being
caused primarily by three factors (Figure 2). Once the operational
design, environmental and engineering controls are in place and
monitored, the major residual risk becomes the consistency and
and operators must excel in their aseptic practice. While gowning
qualification establishes the operator's practical gowning proficiency,
the operator's proficiency in aseptic processing is established through
participation in media fill. It is recognized that the operator's aseptic
technique deteriorates with the passage of time; hence, as part of
the process simulation and during risk assessment, personnel fatigue
factors need to be always considered. Some of this can be eliminated
through the improvement of ergonomics in an operational setting.
All aseptic manipulations need to be made in First Air, not having
passed any other components or being blocked by the operator's
own hands; again, these are tasks requiring meticulous skill to avoid
contamination. A clear delineation of primary and secondary operator
activities is required such that they don't pose incremental risks to
the product. The primary operator, by procedure, needs to be always
cognizant about not contacting non-sanitized or non-sterilized items
www.americanpharmaceuticalreview.com |
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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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