APR March 2024 - 42

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MICROBIOLOGY
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Bacterial Spore Formers in Disinfectant Efficacy Testing
Jim Polarine Jr., MA.
Senior Technical Service Manager
STERIS Corporation
David Shields
Senior Technical Service Manager
STERIS Corporation
Disinfectant efficacy testing is performed to qualify a wet contact
time for disinfectants for use within classified areas of aseptic
manufacturing facilities (e.g., Biopharma, Pharma, Medical Device, etc.).
Disinfectant efficacy testing is a regulatory expectation and designing
a disinfectant efficacy study can be complex, with many different
potential study variables to consider. Periodically, the question is
raised when designing a disinfectant efficacy study: Should bacterial
spore formers be tested against disinfectants that are not considered
sporicidal agents? Considering this possibility, we will evaluate the
question and provide a reasoned approach. Industry regulators are
also interested in bacterial spore testing as noted in a recent FDA 483,
" There was no analysis to determine if the microbial population used
consisted of spores and/or dividing vegetative microorganisms. " 1
From a disinfectant efficacy testing regulatory guidance perspective,
USP 43-NF38 <1072> Disinfectants and Antiseptics defines a chemical
disinfectant as,
" A chemical agent used on inanimate surfaces
and objects to destroy infectious fungi, viruses, and bacteria, but
Table 1. Theoretical Resistance Hierarchy (McDonnell 1999)
not necessarily their spores... " USP 43-NF38 <1072> Disinfectants
and Antiseptics, goes on to define a Sporidical Agent as, " An agent
that destroys bacterial and fungal spores when used in sufficient
concentration for a specified contact time. It is expected to kill all
vegetative microorganisms. " This demonstrates that a disinfectant that
is not considered a sporicidal agent is not expected to exhibit efficacy
against bacterial spores, which are one of the most challenging forms
of microorganism to chemically inactivate. Table 1 demonstrates the
challenge presented by bacterial spores.
Formulated chemical disinfectants are registered for marketing
in a geographical area with the applicable regulatory authority
and should have label claims to support the expected range of
microbicidal efficacy (e.g., bactericidal, fungicidal, sporicidal, etc.).
Label claims for a chemical disinfectant should be reviewed and
evaluated to help guide an end-user to test against an appropriate
range of microorganisms in a disinfectant efficacy study as well
as how to incorporate into the facility's contamination control
program. For example, a use dilution of a phenolic or quaternary
ammonium compound is not expected to exhibit efficacy against
bacterial spores. Negative log10 reductions can even be observed
for non-sporicidal chemical disinfectants against bacterial spores
in a disinfectant efficacy coupon study if the test coupons recover
at a slightly higher value than the positive control coupons, due to
standard error associated with cultural microbial recovery.
Attempting to test against a vegetative form of bacterial spore
former is also not recommended for a litany of reasons. A bacterial
spore presents a significantly greater challenge to disinfection than
a bacterial spore-former vegetative cell. If efficacy data is generated
against a suspension with a significant portion comprised of vegetative
cells, the sporicidal efficacy of a product could be overestimated.
Additionally, the spore form of a bacterial spore former is the most
likely form to be present in a classified area since it may be present and
can survive indefinitely on a variety of surfaces that may be introduced
into a classified area. Vegetative cells of bacterial spore formers are
42 |
| 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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