Stability Testing

Reliable testing and sample storage you can trust

In today’s market, understanding the effects of temperature and humidity on chemical purity as well as potency, bioactivity, particle size, surface area and crystalline phase transitions, is crucial to developing a better product.

At Micron Technologies' Malvern facility, we offer stability testing and sample storage to support our customers’ needs in relation to drug substance and drug product stability.

Our stability testing and storage capabilities meet International Conference on Harmonisation (ICH) guidelines. Various ICH storage conditions are available, and are monitored continuously to ensure compliance to ICH requirements. Storage conditions currently offered by Micron Technologies are 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 5°C and -20°C.

All stability chambers are fully validated to meet strict temperature, humidity and uniformity requirements. They are connected to emergency generator power to ensure the integrity of stored samples.

The following techniques are commonly used to support stability testing programs at Micron Technologies:

• High Performance Liquid Chromatography (HPLC)
• Dissolution Testing
• Particle Size Analysis by Laser Diffraction
• Surface Area analysis by Nitrogen Adsorption
• X-ray Powder Diffraction
• Differential Scanning Calorimetry (DSC)
• Moisture Testing
• Dynamic Vapor Sorption
• Our Quality Assurance Group reviews all analytical data to ensure product quality and adherence to cGMP guidelines.