Stability Storage

A row of large, white walk-in stability chambers with small viewing windows and secured doors in a clean, well-lit biorepository

Precision Stability Storage - CA delivers trusted off-site biological and ICH stability storage solutions, supporting organizations across academia, government, pharmaceutical, and biotechnology sectors. Our California biorepository is a top-tier facility designed to protect critical materials requiring controlled temperature environments.

What We Offer

Stability Storage Temperatures & Humidity Conditions

Empty metal shelving units in a storage room with fluorescent ceiling light.

Our facility supports a full range of ICH-recommended stability storage conditions, including:

Long-term stability storage

25°C / 60% RH
Standard ICH long-term condition used to establish product shelf life in controlled room-temperature environments.

25°C / 40% RH
Lower-humidity long-term storage designed for moisture-sensitive formulations requiring controlled ambient conditions.

Intermediate Stability Storage

30°C / 65% RH
ICH-recommended intermediate condition used when long-term studies show a significant change or additional data is required.

30°C / 75% RH
Higher-humidity intermediate storage supporting specialized regulatory or formulation requirements.

Accelerated Stability Storage

40°C / 75% RH
ICH-standard accelerated condition used to predict long-term stability and support regulatory submissions.

40°C / <25% RH
Low-humidity accelerated storage for moisture-sensitive materials requiring stress testing under controlled dry conditions.

Freezer Storage

–20°C and –80°C Chambers
Supports long-term storage of biological materials, APIs, and research samples requiring ultra-low temperatures.

Controlled Ambient Storage

15°C – 30°C
Monitored ambient environments for materials requiring controlled room temperature conditions outside standard stability protocols.


FACILITY FEATURES FOR ICH STABILITY STORAGE

  • Purpose-built walk-in stability rooms and chambers designed to meet ICH guidelines

  • Fully validated environments with complete IOPQ and temperature/humidity mapping

  • Precise temperature and humidity control to maintain consistent study conditions

  • 24/7 continuous monitoring with automated alarm notifications

  • 21 CFR Part 11–compliant monitoring systems for secure data integrity and traceability

  • Redundant HVAC and conditioning systems to eliminate single points of failure

  • Backup power infrastructure capable of supporting full facility operations

  • Documented Quality Management System (QMS) with SOPs for all critical stability operations

  • Audit-ready documentation to support regulatory inspections and submissions


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