Stability programs

ICH stability

With our robust stability chamber capabilities, we can support you with designing ICH stability studies required for your regulatory submission. 

Among our 5000 m² GMP facilities, Nuvisan is equipped with stability chambers, climate cabinets and standalone stability storage equipment to provide the best possible solution for stability studies during all phases of drug development. 

We offer a wide variety of parameters (temperature, humidity, light) to meet all regulatory (ICH) and product-specific storage requirements. Temperature conditions for zone I/II; IIIa; IIIb and IV are possible at all sites. ICH guideline-compliant studies for frozen products -60°C, -20°C, and 5°C ± 3°C are also among our key capabilities. 

  

In-use stability

In-use stability testing is an essential part of enhancing the performance and integrity of pharmaceutical products once they are opened or used. This testing helps to assess how a drug or product maintains its quality, effectiveness and safety under conditions reflective of its typical use, such as exposure to air, moisture or temperature changes. This is especially crucial for complex formulations and products that require specific storage conditions. 

Our services for in-use stability testing align with industry standards and can be customised based on the product's needs, such as evaluating the impact of handling, dispensing and storage in real-world conditions. With our GMP-certified facilities and expert teams, we can provide reliable data to support regulatory submissions and help ensure that products remain safe and effective throughout their intended use. 

Forced Degradation Studies: Photo - Environmental

We support our clients in early development phases with accelerated stability studies to expedite the final selection of formulation, manufacturing processes, and primary packaging. These studies include forced degradation (temperature -80°C to +60°C, humidity 10% RH to 90% RH; oxidation with H₂O₂; pH: acid, base; light sensitivity; as well as, for the Brazilian market, reaction with Fe³⁺ and Cu²⁺). We also offer photostability studies conducted in fully automated chambers. UV and VIS light can be independently calculated and adapted to the project. 

Primary package testing and compatibility

Primary package testing and compatibility studies are essential to our ability to help our clients ensure the quality and stability of drug products. We evaluate the interaction between pharmaceutical formulations and their packaging materials, assessing factors like moisture, temperature and light exposure. Our testing supports both small molecule and biologic products, helping ensure they maintain their integrity throughout storage and transportation. These studies are crucial for regulatory submissions and helping ensure product safety and efficacy over time.

Transportation studies

Transportation studies are a key part of the pharmaceutical development process. These studies evaluate the stability and integrity of drug products during transportation; to help ensure they remain effective and safe for clinical use. Nuvisan conducts these studies in compliance with industry standards and offers robust support for global supply chains. Our facilities and expertise are optimised for handling diverse transportation conditions, helping ensure that drugs, including biologics and other sensitive formulations, maintain their quality throughout the transport process.

Freeze – thaw cycling

Freeze–thaw stability studies are becoming more relevant in drug product development, and our team of experts specialises in stability studies, offering expertise in freeze–thaw cycling studies in a temperature range from -40°C to +40°C. Freeze-thaw cycling is a critical component of our stability testing services, helping ensure the resilience and reliability of drug products under temperature fluctuations. We conduct these studies across a range of conditions, from benchtop stability to long-term assessments, including ICH-recommended freeze–thaw cycles. This process is essential for evaluating the stability of biologics and other sensitive drug formulations during storage and transport.