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Stability Testing

Chambers designed to meet ICH, FDA, GMP, and GLP guidelines


Pharmaceutical Stability Testing

Stability testing provides evidence to a regulatory body that the quality of the product or raw material doesn’t vary with time, under the influence of a range of different factors including temperature, humidity and light. ESPEC Stability Chambers meet or exceed current regulations of the Medicines and Health Regulatory Authority (MHRA), Food and Drug Administration (FDA) or other competent regulatory organisations.

ESPEC stability chambers test:

  • Shelf life
  • Ingredient degradation
  • Packaging
  • Expiration Dating

Summarized below are the recommended environmental conditions per Q1A(R2): (Stability Testing of New Drug Substances and Products).
An increasing number of pharmaceutical companies are requesting the calibration of data loggers to cover these requirements.

    StudyStorage conditionMinimum time period
    Long Term 25°C ± 2°C / 60% RH ± 5% RH 12 months
    30°C ± 2°C / 65% RH ± 5% RH 12 months
    Intermediate 30°C ± 2°C / 65% RH ± 5% RH 6 months
    Accelerated 40°C ± 2°C / 75% RH ± 5% RH 6 months
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    Stability Testing Model Comparison

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    Model / Link Interior Dimensions
    (W x D x H)
    Interior Volume Temperature Range Humidity Control Notes
    EZO30-WA 27.5" x 27.8" x 63.5" 28.1 cu. ft. 10 to 65°C Yes
    EZO60-WA 55" x 27.8" x 63.5" 56 cu. ft. 10 to 65°C Yes
    BTZ-475 19.6" x 15" x 23.6" 4 cu. ft. -70 to 180°C No up to 2.75°C/min. Also available with humidity control
    ESPB364 62" x 108" x 94" 364 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min. Galvanized or stainless steel interior
    ESPB499 85" x 108" x 94" 499 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min. Galvanized or stainless steel interior
    ESPB634 108" x 108" x 94" 634 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min. Galvanized or stainless steel interior
    ESPB770 131" x 108" x 94" 770 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min. Galvanized or stainless steel interior
    ESPB904 154" x 108" x 94" 904 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min. Galvanized or stainless steel interior
    ESPB1040 177" x 108" x 94" 1040 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min. Galvanized or stainless steel interior
    Click model number for details, including metric & english units.

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