APR March 2024 - 36

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BIOPHARMACEUTICALS
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Technologies for Aseptic Filling: The Choice is Clear
James Agalloco
President
Agalloco & Associates
Phil DeSantis
Principal
DeSantis Consulting Associates
Introduction
Over the last forty years technologies for the aseptic production
of sterile products have advanced significantly. Where staffed
clean rooms once provided most of the operational capacity, new
production means have been gradually introduced. Isolator use
began in the 1980's, to be followed shortly by Restricted Access
Barrier Systems (RABS), their somewhat simpler descendant. In 2007,
Agalloco, Akers and Madsen outlined criteria to be used in selecting a
suitable aseptic filling technology.1
When originally written there was
a paucity of experience and limited comparative data available for use
in the decision process. With the passage of time, it is now possible
to draw upon published content to assist in the selection process.
This publication relies upon the experience and analysis of others to
provide a clear picture of the appropriate technology choice to make
for aseptic processing.
First and foremost, it should be apparent to all that the era of staffed
cleanrooms for aseptic processing is over. There is no justification
for construction of a new aseptic facility where the operator is not
physically separated from the critical environment in 2024. Any
new aseptic process should adhere to the precepts of advanced
aseptic processing.
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| March 2024
" An advanced aseptic process is one in which direct intervention with
open product containers or exposed product contact surfaces is not
required and never permitted by operators wearing conventional
cleanroom garments. " 2
Secondly, this might suggest that all versions of RABS satisfy the
precepts behind this definition. That is not the case, RABS which
allow for 'open door' interventions by aseptically garbed personnel
are not advanced technologies. The definition excludes " open " RABS
which require operator intervention for set-up and mid-process
interventions. Even some " closed " RABS fail to meet the criteria,
largely because of the invasive manual decontamination processes
utilized. The cRABS design in which the enclosure is decontaminated
after set-up and is never entered during aseptic processing would be
considered advanced.
There are only two serious technology contenders meeting the
advanced aseptic process expectations for the commercial production
of sterile products - cRABS and isolators. These technologies are
the subject of this publication and we have chosen to rely heavily
on comparative assessments performed by others to define the
preferred processing technology. We believe this approach increases
objectivity and reduces the significance of our personal opinions. We
have considered only comparisons based upon filling of small volume
parenterals with the following features:

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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