Stability Storage
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
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