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    Myth and Facts Depyro Tunnel

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    Mohamed Hassan
    1) While a 3-log reduction in endotoxins is commonly used as a standard, it is a myth that exactly 3 minutes at 300°C is always necessary for depyrogenation in a dry heat tunnel. 2) The key requirement is demonstrating at least a 3-log reduction, but this can be achieved with varying time-temperature conditions, and FD values provide a metric but do not have a fixed acceptance criteria. 3) Ensuring all items are exposed to the validated minimum temperature for the validated minimum time is important for effective depyrogenation.

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    Myth and Facts Depyro Tunnel

    Uploaded by

    Mohamed Hassan
    29 views7 pages
    1) While a 3-log reduction in endotoxins is commonly used as a standard, it is a myth that exactly 3 minutes at 300°C is always necessary for depyrogenation in a dry heat tunnel. 2) The key requirement is demonstrating at least a 3-log reduction, but this can be achieved with varying time-temperature conditions, and FD values provide a metric but do not have a fixed acceptance criteria. 3) Ensuring all items are exposed to the validated minimum temperature for the validated minimum time is important for effective depyrogenation.

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    Myth and facts depyro tunnel

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    1) While a 3-log reduction in endotoxins is commonly used as a standard, it is a myth that exactly 3 minutes at 300°C is always necessary for depyrogenation in a dry heat tunnel. 2) The key requirement is demonstrating at least a 3-log reduction, but this can be achieved with varying time-temperature conditions, and FD values provide a metric but do not have a fixed acceptance criteria. 3) Ensuring all items are exposed to the validated minimum temperature for the validated minimum time is important for effective depyrogenation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views7 pages

    Myth and Facts Depyro Tunnel

    Uploaded by

    Mohamed Hassan
    1) While a 3-log reduction in endotoxins is commonly used as a standard, it is a myth that exactly 3 minutes at 300°C is always necessary for depyrogenation in a dry heat tunnel. 2) The key requirement is demonstrating at least a 3-log reduction, but this can be achieved with varying time-temperature conditions, and FD values provide a metric but do not have a fixed acceptance criteria. 3) Ensuring all items are exposed to the validated minimum temperature for the validated minimum time is important for effective depyrogenation.

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    Myth or Facts ?

    Exposure of 3 min at 300°C necessary


    for Depyrogenation in Tunnel (Dry heat)
    Performance Qualification?

    Presented By : Palash Ch. Das


    • Not less than a 3.0 log reduction in recoverable endotoxin is
    used as a standard for process validation. The log reduction is
    calculated by determining the measured log of recoverable
    endotoxin in the unprocessed item minus the measured log of
    recoverable endotoxin remaining in the processed item.
    Myth or Facts - 3 • FD value: Calculation of an F-Value at each probe location may
    min at 300°C be useful tool to help in assessing process comparability ,
    evaluation process repeatability, or location of cool areas.
    required for There is no minimum FH value acceptance criteria for
    Depyrogenation depyrogenation. Endotoxin inactivation efficacies cannot be
    accurately correlated with standard dry-heat lethality
    in Tunnel ? conventions (FD) which rely upon a linear destruction model.
    • Depyrogenation processes typically operate at a range of
    temperature from approximately 220°C and 400 °C. FD = 1 is
    defined as the depyrogenation effect achieved by 1 min of
    heating at 250. (see the calculation slide)
    • Considering different time and temperature set point during
    thermal study will provide variation in delivered FD value.
    • Demonstrating ≥ 3 log reduction endotoxin with reduced time
    -temperature condition from those utilize in routine
    Myth or Facts - 3 processing will consider as a successful depyrogenation. The FD
    min at 300°C value achieved during the study can be compare with periodic
    FD value to ensure system operated in a validated state of
    required for control and there no significant nonconformance during the
    process. Therefore, FD active with the validated recipe and
    Depyrogenation predefined equipment setting (e.g. time and temperature ,
    belt speed, Air velocity and differential pressure etc.) can be
    in Tunnel ? consider as critical control for review during routine batch
    processing.
    • It is important that every article in the tunnel be exposed to at
    least the stated temperature for not less than the stated time.
    How to calculate FD for dry heat
    depyrogenation (reference USP1228.1)

    FD Calculation considering 300 °C minimum set temperature :


    FD=ΔT Σ10(T-250)/Z
    FD =3×10(300-250)/50
    FD =3×10 50/50
    FD =3×10
    FD =30
    If tunnel hot zone maintain minimum 300 °C for 3-minute
    during dynamic condition FD will be more than 30.
    • Definitions:
    ▪ depyrogenation process: series of actions or
    operations needed to achieve the specified
    requirements for removal or inactivation of Pyrogens
    ▪ Depyrogenation: validated process designed to
    Myth or Facts - 3 remove or inactivate pyrogenic material, by a
    specified quantity, which is monitored by inactivation
    min at 300°C of endotoxin
    required for ▪ Inactivation: loss of ability of microorganisms to
    Depyrogenation grow and/or multiply
    • References :
    in Tunnel ?
    ▪ 5.1.12 Depyrogenation of item for parenteral
    preparation , European Pharmacopoeia 10.3
    ▪ TR 3 Rev2013
    ▪ ANSI/AAMI/ISO 20857:2021
    ▪ USP <1228.1>
    • Exposure of 3 min at 300°C necessary for
    Depyrogenation in Tunnel (Dry heat)
    Performance Qualification?
    ▪ Consider as myth , A 3-log10 reduction of a
    Conclusion standard endotoxin challenge is typical;
    however, a lower level of reduction can be
    validated, provided that a programme is in
    place to ensure that pyrogen levels are
    controlled to the validated limits.
    Thank You

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