Stability Testing

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

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.

Study Storage condition Minimum 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
     

Resources

Pharmaceutical Applications

Stability Testing

Literature Downloads

Stability Testing Model Comparison

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.
ESPB355 61" x 107" x 94" 355 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min.
ESPB489 84" x 107" x 94" 499 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min.
ESPB623 107" x 107" x 94" 634 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min.
ESPB757 107" x 130" x 94" 770 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min.
ESPB891 107" x 153" x 94" 904 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min.
ESPB1024 107" x 176" x 94" 1040 cu. ft. (-10 or 10) to 85°C Optional up to <1°C/min.
Click model number for details, including metric & english units.

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