ICH stability studies
ICH Stability Studies Made Easier
ICH stability studies are crucial for ensuring product integrity over time. Stancor Pharma provides high-quality contract manufacturing services tailored to this need.
The wear problem
In stability studies, components face wear mechanisms such as impact and sliding abrasion, particularly in environments with high humidity or temperature fluctuations. Failure often occurs at seals and closures, leading to contamination and product instability.
Recommended plate by component
| Component | Grade | Thickness | Why |
|---|---|---|---|
| Seals | oncology injectables | 2-5 mm | Extended service life due to enhanced resistance to degradation. |
| Pumps | biosimilar development programmes | 5-10 mm | Increased reliability and reduced maintenance needs in continuous operation. |
| Fittings | cosmetics | 3-6 mm | Improved durability to ensure consistent product quality during stability testing. |
| Hoses | general injectables | 4-8 mm | Enhanced flexibility and wear resistance, prolonging the lifespan of manufacturing equipment. |
| Valves | oral dosage forms | 6-12 mm | Optimized performance reduces the risk of leaks and contamination. |
Selecting the right plate
Choose tested materials
Select materials that can withstand the specific challenges of ICH stability testing.
Consult with experts
Engage with our specialists to determine the best solutions for your formulations.
Focus on quality assurance
Prioritize components that meet stringent quality standards to ensure product stability.
Assess compatibility
Make sure all materials are compatible with your specific formulation requirements.
Questions engineers ask
What are ICH stability studies?
ICH stability studies evaluate how a drug product maintains its quality over time under specific conditions. This process is vital for regulatory approvals.
Why choose Stancor Pharma for my studies?
Stancor Pharma specializes in contract manufacturing tailored to ICH compliance, ensuring your products are made to the highest standards.
How can I ensure my product's integrity?
By selecting robust materials and staying compliant with manufacturing protocols, you can significantly enhance your product's integrity during studies.
What should I consider when selecting components?
Evaluate the wear mechanisms, environmental conditions, and formulation compatibility to select the right materials for your applications.
Get a quotation for ich stability studies
Send your specification and requirement and we respond with options and a full release data pack.
Request a quotation