APR March 2024 - 37

« BIOPHARMACEUTICALS
* continuous infeed of containers and discharge of
closed containers
* use of transfer devices for material / component entry/exit
* automated decontamination of the critical zone
* line automation for weight checks / remote adjustment
* no gowned personnel access for decontamination
or operation
Evaluation Criteria
We have elected to utilize the same criteria employed in the original
document, using the referenced documents wherever possible to
determine preference. The importance of the aseptic technology
Criterion
Facility Lead Time - The time period required to bring the facility into full operation
exclusive of the qualification/validation period.
Initial Facility Cost - The installed cost for the facility including infrastructure,, facility
systems, and process equipment.
Qualification Duration - The time required to complete the qualification of the facility
including environmental control systems or isolator decontamination.
Qualification Obstacles - Unique problems associated with the technology choices
that hinder the completion of the qualification/validation effort.
Operating Cost - Cost to operate the facility including utilities, personnel, sanitization
materials and labor, environmental monitoring (including cost of testing), gowning
materials and consumables.
Operational Hurdles - Difficulties associated with the use of technology for
aseptic filling.
Line Preparation - Those activities required to ready the line for filling.
Environmental Sanitization - The methods used for disinfection/sanitization of the
processing environment or the decontamination of the isolator.
Line Operation - Impact on the routine use of the line.
Environmental Monitoring - The requirements for periodic sampling of the
processing environment.
Process Simulation - Media fill execution as required initially and periodically
Impact of Personnel - The extent to which personnel practices can influence
aseptic operations.
Cleaning - Methods for cleaning product contact and non-product contact parts.
Change Over - Conversion of the line from one size/format to another.
Suitability for Campaign Usage - Considerations relative to the repetitive use of the
line for the same product format.
System Maintenance - Impact of system maintenance during the aseptic
filling operation.
Complexity - The overall complexity of the facility and its equipment.
Containment Utility - The potential for utilization of the facility for the aseptic
processing of potent compounds.
Novelty - The degree of novelty associated with the facility and equipment.
Regulatory Views - The perception of the technology from the perspective of the
inspector/reviewer.
Industry Perspectives - The end users' views of the technology.
Intangibles - Factors not specifically addressed in the prior elements.
selection process is of such import that considerable deliberation
should be given to each of the relevant factors.
The evaluation process should address each of the following: facility
lead time; initial facility cost; qualification duration; qualification
obstacles; operating cost; operational hurdles; line preparation;
environmental sanitization; line operation; environmental
monitoring; process simulation; impact of personnel; cleaning;
change over; suitability for campaign usage; system maintenance;
complexity; novelty; regulatory expectations; industry perspectives
and intangibles.
Rather than create a lengthy narrative on each criterion, we have
included a description, the suggested preference, and a brief
rationale statement. The references we have used are listed in the
Bibliography and a thorough reading of this collection supports the
stated preference.
Table 1.
Preference Rationale
Isolator
Isolator
Isolator
Isolator
Fabrication, qualification and validation of the isolator can proceed in parallel with facility
construction. RABS system cannot be fully qualified until completion of the facility.
Isolators may be installed in Grade C or D clean rooms. RABS must be located within a
Grade B background, often with a Grade A perimeter around the RABS exterior.
The majority of isolator system qualification can proceed in parallel with
facility construction.
cRABS system decontamination whether extended to include the background or
as supplemental to the enclosure itself requires design/installation specific cycle
development/decontamination validation efforts.
Isolator
None
cRABS
None
Isolator
None
None
Isolator
cRABS
cRABS
Isolator
Isolator
Isolator
Isolator
None
Isolator
Isolator
Isolator
Regulators have expressed preferences for the use of isolation technology
The increasing preference for isolation technology by manufacturers is clear.
Isolation technology continues to advance including newer systems without gloves.
Isolators provide superior performance
Dirty part removal is easier with cRABS
cRABS systems allow greater access during non-operating periods
Air overspill from cRABS make lengthy operation more problematic. Surveys indicate
cRABS campaigns are shorter than those in isolator systems
Isolators provide for separative access during operation.
cRABS require increased integration of equipment and facility systems especially for
HVAC operation
Air overspill from cRABS make the containment of potent materials extremely difficult.
Isolators provide superior separation between personnel and the critical zone
Isolator designs can restrict flexibility within the critical environment for assembly set-up
in a confined space.
Utility cost for Grade A/B areas, cost of gowning, increased labor and increased
environmental monitoring for cRABS systems and classified areas, increased labor for
decontamination of classified areas.
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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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