Ensure the integrity, quality, and compliance of your products with DDL’s world-class ICH stability storage solutions. DDL provides secure, fully controlled environments designed to meet the rigorous requirements of the International Council for Harmonization (ICH) guidelines, including ICH Q1A (R2) for stability testing performed under GMP and ISO 17025 quality systems.
Why Stability Storage Matters
Stability testing is a critical step in the product development process, especially for pharmaceutical products and combination products. Stability studies provide evidence to determine how environmental factors like temperature and humidity that impact the shelf life, safety, and efficacy of these products. Our GMP Lab is purpose-built to provide the precise, consistent conditions needed to generate reliable, regulatory-compliant data for your regulatory submissions and product approvals.
ICH-Compliant Storage Conditions
DDL offers a full range of stability storage chambers with continuous monitoring and validated backup systems, supporting both long-term and accelerated studies:
- Long-Term Storage:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- Intermediate Storage:
- 30°C ± 2°C / 65% RH ± 5% RH
- Accelerated Storage:
- 40°C ± 2°C / 75% RH ± 5% RH
- Custom Conditions: Tailored solutions for specific product requirements, including refrigerated (2°C–8°C) and frozen (-20°C / -80°C) storage.
Our Capabilities
- Mapped & Calibrated Chambers: Validated environments for both short-term (accelerated) and long-term stability programs.
- Continuous Monitoring: 24/7, validated monitoring for temperature and humidity to maintain protocol compliance.
- Power Continuity: Chambers and monitoring systems are supported by external backup generators to protect samples during power events.
- Capacity: DDL’s laboratory network contains over 100,000 cubic feet of controlled storage space.
Partner with DDL
Accelerate your program with a reliable and proven partner who combines capacity, compliance, experience and speed. Tell us your required set points, pull schedules, and reporting needs—we’ll configure a storage plan that aligns with ICH guidelines and your protocol.
Contact us for more information or to talk to an engineer.
