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    Llenado Aseptico PDF

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    Lucia Rodriguez Aguilar
    The document summarizes revisions made to PDA Technical Report No. 22 (TR22), which provides guidance on aseptic process simulations. The revisions were meant to clarify aspects like worst-case conditions, intervention management, personnel qualification, and ongoing assessments. Key changes included adding sections on risk assessment, intervention identification and management, and personnel training qualifications. The revisions aim to further demonstrate process capability and control through aseptic process simulations.

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    Llenado Aseptico PDF

    Uploaded by

    Lucia Rodriguez Aguilar
    176 views20 pages
    The document summarizes revisions made to PDA Technical Report No. 22 (TR22), which provides guidance on aseptic process simulations. The revisions were meant to clarify aspects like worst-case conditions, intervention management, personnel qualification, and ongoing assessments. Key changes included adding sections on risk assessment, intervention identification and management, and personnel training qualifications. The revisions aim to further demonstrate process capability and control through aseptic process simulations.

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    The document summarizes revisions made to PDA Technical Report No. 22 (TR22), which provides guidance on aseptic process simulations. The revisions were meant to clarify aspects like worst-case conditions, intervention management, personnel qualification, and ongoing assessments. Key changes included adding sections on risk assessment, intervention identification and management, and personnel training qualifications. The revisions aim to further demonstrate process capability and control through aseptic process simulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    176 views20 pages

    Llenado Aseptico PDF

    Uploaded by

    Lucia Rodriguez Aguilar
    The document summarizes revisions made to PDA Technical Report No. 22 (TR22), which provides guidance on aseptic process simulations. The revisions were meant to clarify aspects like worst-case conditions, intervention management, personnel qualification, and ongoing assessments. Key changes included adding sections on risk assessment, intervention identification and management, and personnel training qualifications. The revisions aim to further demonstrate process capability and control through aseptic process simulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 20
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    The key takeaways are that PDA TR22 is being revised to provide clarification on worst case conditions, intervention management, personnel qualification and risk assessment tools. It also adds sections on these topics as well as appendices on media preparation and the execution sequence of APS activities.

    The purpose of an APS is to demonstrate the capability of the aseptic process to produce sterile products, evaluate personnel proficiency, comply with cGMP requirements, and confirm appropriate operating practices.

    Some of the key changes to TR22 include clarification on worst case conditions and APS durations, adding a risk assessment, sections on intervention management and personnel qualification, and appendices on media preparation and the APS execution sequence.

    PDA: A Global

    Association

    Update on PDA TR22


    Revisions for Aseptic Process
    Simulations
    Anthony Pavell
    Associate Director,
    APP Pharmaceuticals
    2

    Agenda
    Definition TR22
    Why the revision
    Whats Changing
    Conclusions
    Acknowledgements

    Definition of TR22
    Initial version published in 1996, replaces:
    Technical Monograph No. 2, Validation of Aseptic
    Filling for Solution Drug Products, 1980;
    Technical Report No. 6, Validation of Aseptic Drug
    Powder Filling Processes, 1984
    Provide a valuable guide to industry in the area of
    process simulation testing
    Addresses the validation of aseptic processing during
    formulation and filling activities
    An APS is a simulation of the entire aseptic formulation
    and filling process, which substitutes a microbiological
    growth medium for a sterile product.

    Why the Revision


    Periodic Review originally published in 1996
    Develop a modest revision / expansion of PDA TR#22,
    Update / clarify coverage of interventions.
    Address personnel participation in a meaningful and
    coherent fashion.
    Include an accountability discussion.
    Clarify application to aseptic steps in the drug
    compounding process.
    Outline execution practice in greater detail.
    Maintain consistency with regulatory guidance
    (especially FDAs 2004 AP guide).

    Important Points to Consider


    APS demonstrates capability, does not determine an
    SAL.
    Interventions are either:
    Inherent a integral part of the process
    Corrective performed to fix problems

    Interventions must be the focus of the discussion,


    because contamination is largely associated with
    them.
    Aseptic process simulation, is not just media filling.

    Purpose of the APS


    Demonstrate as part of an overall process validation
    approach, the capability of the aseptic process to
    produce sterile drug products.
    Evaluate proficiency of aseptic processing personnel.
    Comply with current Good Manufacturing Practice
    requirements.
    Confirm the appropriateness of operating practices
    used in support of aseptic processing.

    Whats Changing Section 2


    PROCESS SIMULATION CONCEPTS AND
    PRINCIPLES
    No change to typical six month interval
    Providing clarity around worst case conditions
    Present a reasonable challenge to the system
    without forcing unintentional failure
    Duration is equal to a maximum production run
    including
    Shifts
    Room/equipment time
    Extremes of container sizes and rates

    Whats Changing Section 2


    RISK ASSESSMENT ADDITION
    A risk assessment may be performed to determine,
    identify, and rate the aseptic process steps and
    interventions, which can potentially adversely affect the
    sterility assurance of the product.
    These process impacting steps and interventions
    should be included in the process simulation study.
    Other steps and interventions which do not affect the
    sterility assurance of the product may be included in the
    study at the discretion of the company.

    Whats Changing Section 3


    PROCESS SIMULATION TEST
    DOCUMENTATION
    Media fills do not support the filtration validation of the
    product / process being simulated, so differences in
    filtration area, filter media, etc are acceptable
    Expanded content for aseptic compounding steps and
    recommend that processes requiring the addition of
    sterile powders employ an acceptable placebo material
    in containers identical to those utilized in the process
    being evaluated
    Anaerobic media would be appropriate where strict
    anaerobic conditions are present
    NOTE: The aseptic production of sterile bulk
    pharmaceuticals is addressed in PDAs TR #28
    10

    Whats Changing Section 6


    ELEMENTS OF PROCESS SIMULATION
    TESTS
    Created Section 7 to discuss intervention identification and
    management
    Recommend that the frequency of intervention during APS
    be related to the frequency of occurrence in production.
    Recommend that the APS duration be long enough to
    stress the process, the supporting environment and the
    operators
    Recommend that the number of units filled during each
    manual process simulation study represent the maximum
    production lot size.
    Incubate for a minimum of 14 days unless supported by a
    validated approved alternative method (Rapid Methods)
    11

    Whats Changing Section 6


    ELEMENTS OF PROCESS SIMULATION
    TESTS
    Added Section for Unit Accountability and Reconciliation
    Recommend an accurate count of integral media-filled
    containers be performed
    An accurate unit count may be obtained by one of the
    following methods:
    Use of a calibrated counter with demonstrated
    accuracy
    A nested or divided tray configuration
    A verified physical count
    Complete unit accountability of the APS is the goal

    12

    Whats Changing Section 7


    INTERVENTION MANAGEMENT New
    Section
    Created to discuss intervention identification and
    management
    Provides Guidance for:
    Study Design
    The human operator is by far the greatest source of
    microbial contamination during an aseptic process.
    To demonstrate aseptic processing capability,
    process simulation programs should include all the
    inherent (part of the process) and corrective
    (problem resolution) activities that occur during an
    aseptic filling process
    May accommodate similar configurations
    Frequency
    At least once annually
    13

    Whats Changing Section 7


    INTERVENTION MANAGEMENT, continued
    Inherent Interventions
    An integral part of the aseptic process required for
    either set-up, routine operation and/or monitoring, e.g.,
    aseptic assembly, container replenishment,
    environmental sampling, etc. Inherent interventions are
    required by batch record, procedure, or work instruction
    for the execution of the aseptic process.
    Corrective Interventions
    Performed to correct or adjust an aseptic process
    during its execution. These may not occur with the
    same frequency (or at all) in the aseptic process.
    Examples include such activities as: clearing component
    jams, stopping leaks, adjusting sensors, and replacing
    equipment components. Corrective measures should be
    taken to reduce their extent and frequency.
    14

    Whats Changing Section 7


    INTERVENTION MANAGEMENT, continued
    Monitoring
    The documentation in the batch record will allow for
    identification, cataloging and trending
    Incubation of Interventions Related Containers
    If written procedures and batch documentation are
    adequate to describe an associated clearance, the
    intervention units removed during media fills do not
    need to be incubated

    15

    Whats Changing Section 8


    PERSONNEL QUALIFICATION NEW
    SECTION
    Complete training that provides an understanding of:
    Basic microbiological concepts
    How contamination is generated and spread
    Control of contamination risks (eg. gowning,
    behavior)
    An appreciation of the consequences of a patient
    receiving a non-sterile product.
    Recommend that operators are qualified with an off-line
    individual test to confirm that they understand and can
    execute basic aseptic techniques
    Set-up and other complex interventions are excluded
    from off-line qualification.
    Recommend that Operators work under direct supervision
    until they have achieved the required proficiency to perform
    independently.
    16

    Whats Changing Section 10


    ONGOING ASSESSMENTS
    Re-titled Maintenance to convey that the process of
    assessing a state of control must be an ongoing process
    Utilize Risk Management Tools to assess needs
    Not strictly time driven, although 6 months is typical
    Not strictly event driven, controlled maintenance
    activities may be allowed
    Assess new container closure systems through
    previously qualified systems
    Equipment preparation and assembly modifications
    An aseptic process simulation must not be used to justify
    practices that pose unnecessary contamination risk

    17

    Whats Changing Appendix 2 and 3


    Two new appendices:
    Appendix 2 Media Preparation and Sterilization
    Outlines alternatives
    Allows for variation from process
    Does not validate process filtration
    Appendix 3 Aseptic Process Simulation Execution
    Sequence
    Outline for sequencing of APS activities included

    18

    Conclusions
    No major changes to the approach or intent
    Added clarifications for:
    Worst case conditions
    APS durations and design
    Application of Risk Assessment Tools
    Added new sections for:
    Intervention Management
    Personnel Qualification
    PDA submitted for Regulatory Review to:
    FDA

    EMEA

    Health Canada

    TGA

    Koseisho

    PIC/S
    19

    Acknowledgements

    Mr. James Agalloco, Agalloco and Associates, Co-Chair


    Mr. James Akers, Akers, Kennedy and Associates
    Mr. Harold S. Baseman, Valsource, LLP, Co-Chair
    Mr. Richard Boeh, Novo Nordisk Pharamaceutical Industries
    Mr. Robert Darius, GlaxoSmithKline
    Mr. Don E. Elinski, Lachman Consultant Services, Inc.
    Mr. Rick L. Friedman, Food and Drug Administration
    Ms. Carole Lampe, Baxter Healthcare Corporation
    Mr. Stephen Langille, Food and Drug Administration
    Ms. Sandra Lowery, Quality Systems Consulting
    Mr. Russell Madsen, The Williamsburg Group
    Mr. Gary McNassor, Pfizer
    Gerry Morris, PhD, Eli Lilly and Company
    Mr. Anthony M. Pavell, APP Pharmaceuticals
    Ms. Maureen Regan Mueller, Quality Systems Consulting

    20

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