Stability Storage and Testing services
Nordic BioAnalysis AB provides comprehensive stability storage and testing solutions to support pharmaceutical product development, quality control, and regulatory submissions.
Our facilities are qualified according to ICH Q1A guidelines and equipped with temperature- and humidity-controlled chambers, real-time monitoring, backup systems, and secure access control. We offer flexible programs tailored to the needs of drug substances, drug products, medical devices, and packaging materials
Our stability system
Temperature and humidity-controlled chambers. Monitored 24/7 with an alert system and consistent calibration
Stability Studies
Long-term Stability Studies
Products are stored under recommended ICH conditions for extended periods to monitor changes in physical, chemical, and microbiological properties. The data supports shelf life assignment and expiry dating.
Accelerated Stability Studies
Forced Degradation Studies
Storage conditions
We provide temperature- and humidity-controlled chambers for a variety of storage needs:
- -70°C
- -20°C
- +5°C
- +25°C/60%RH
- +40°C/75%RH
- +30°C/75%RH
- Room temperature/ambient humidity
All conditions are continuously logged and deviations are managed according to internal procedures. Chambers are qualified and calibrated regularly to ensure product and result integrity.
Applications
Our stability programs support a wide range of use cases:
- Drug substance and drug product stability studies
- Medical device component storage
- Packaging material evaluations
- Ongoing or follow-up stability programs
- Retention sample storage
We also offer testing and analysis in conjunction with storage programs.