Stability Storage and Testing services
Nordic BioAnalysis AB runs stability studies that give you the data to set shelf life, monitor product quality over time and support regulatory submissions. Storage and analytical testing are performed in the same laboratory, so your samples stay with one partner from study setup to reported result.
Our chambers are qualified according to ICH Q1A(R2), temperature- and humidity-controlled, continuously monitored and supported by alarm and backup systems. Programmes cover 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 ICH Q1A(R2) long-term conditions, 25 °C/60 % RH, or at 30 °C/75 % RH for climatic zone IVb markets, for extended periods to monitor changes in physical, chemical, and microbiological properties. The data supports shelf life assignment and expiry dating.
Accelerated Stability Studies
Accelerated testing simulates long-term storage by exposing products to elevated temperature and humidity, 40 °C/75 % RH. It provides early insights into product degradation and helps identify potential stability risks during development.
Forced Degradation Studies
In forced degradation, products are subjected to stress conditions such as heat, humidity, oxidation, hydrolysis and pH extremes. This reveals degradation pathways and supports the validation of stability-indicating analytical methods.
Photostability testing to ICH Q1B is currently not part of our service offering.
Storage conditions
We provide temperature- and humidity-controlled chambers for a variety of storage needs:
- −70 °C
- −20 °C
- +5 °C / ambient humidity
- +20 °C / ambient humidity
- +25 °C / 60 % RH
- +30 °C / 75 % RH
- +40 °C / 75 % RH
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
Because storage and analytical testing are handled in the same laboratory, samples are not shipped between suppliers at each time point.
Contact us
To discuss your stability storage needs or request a quotation, please reach out to our team!