Stability Testing and Storage Conditions

    Stability Testing and Storage Conditions

    Secure conditions and broad range of parameters
    Pace Analytical Life Sciences (PLS) offers more than 15,000 cubic feet of storage space, with conditions maintained at set-points and tolerances consistent with ICH requirements and custom stability storage conditions.  All stability chambers feature controlled access and are fully mapped and continuously monitored for temperature/humidity at multiple locations by a validated computerized monitoring system. The use of multiple sensors throughout the chambers reduces the risk of out-of-tolerance microenvironments and aids in the management of varying chamber load configurations. Storage is alarmed for out-of-tolerance conditions and supplied with back-up power systems.

    ICH Storage Conditions:
    Pace Analytical maintains controlled temperature / humidity chambers for long-term, intermediate, and accelerated studies for each of the ICH Climatic zones.

    ICH Refrigerated = 5°C, Walk-In

    ICH Climatic Zone I, Long-term Storage = 21°C/45% RH

    ICH Climatic Zone II, Long-term Storage = 25°C/60% RH, Walk-In

    ICH Climatic Zone III, Long-term Storage = 30°C/35% RH

    ICH Climatic Zone IV, Long-term Storage = 30°C/65% RH, Walk-In

    ICH Climatic Zone IVb, Long-term Storage = 30°C/75% RH

    ICH Accelerated = 40°C/75% RH, Walk-In

    Our Full List of current ICH- and custom-condition stability storage:

    -80°C, Reach-In

    -20°C, Reach-In

    5°C, Walk-In (ICH Refrigerated)

    21°C/45% RH (ICH Climatic Zone I, Long-term Storage)

    25°C/40% RH, Walk-In

    25°C/60% RH, Walk-In (ICH Climatic Zone II, Long-term Storage)

    30°C/35% RH (ICH Climatic Zone III, Long-term Storage)

    30°C/65% RH, Walk-In (ICH Climatic Zone IV, Long-term Storage)

    30°C/75% RH (ICH Climatic Zone IVb, Long-term Storage)

    40°C/75% RH, Walk-In

    50°C/10% RH

    50°C/ Ambient RH

    60°C/ Ambient RH

    37°C, 45°C and 50°C Accelerated Aging

    Custom conditions and reach-in chambers

    Photo-Stability, ICH Q1b (Option 2)

    The conditions maintained are subject to change based on the demands of client studies, and new conditions are frequently added. Contact your Project Manager or Account Executive to discuss your study. Let us confirm capacity and provide a storage proposal to address your needs.

    Read more about Pace's Stability Testing and Storage Services .

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    Pace Life Sciences has more than 15,000 cubic feet of stability storage space.