Stability Studies for
Sterile Injectables
Ensuring Product Integrity and Safety Over Time
Reliable Stability Studies for Sterile Manufacturing
Afton Scientific provides robust stability testing services designed to assess the long-term safety, efficacy, and shelf life of sterile injectable products. We offer ICH-compliant studies (Q1A-Q1E) that help ensure product quality throughout its lifecycle.
Our expert team leverages advanced analytical techniques and state-of-the-art storage capabilities to support regulatory submissions and market readiness with confidence.
Tailored Stability Studies to Meet Your Needs
Afton Scientific offers a comprehensive range of stability study services, including:
Real-Time and Accelerated Stability Studies
Assessing product performance under normal and stressed conditions.
Forced Degradation Studies
Simulating extreme conditions to predict degradation pathways.
Packaging and Container Closure Evaluations
Ensuring compatibility with packaging materials.
State-of-the-Art Stability Chambers
Our stability storage solutions provide:
- Controlled Temperature & Humidity Conditions – Supporting long-term, intermediate, and accelerated stability studies.
- ICH-Compliant Storage Parameters – Ensuring compliance with FDA, EMA, and global regulatory standards.
- Real-Time Environmental Monitoring – Continuous tracking for data integrity and compliance.
Comprehensive Analysis to Support Stability
Analytical testing plays a crucial role in stability studies by:
- Monitoring Potency and Purity Over Time – Ensuring therapeutic effectiveness remains intact.
- Detecting Degradation Products and Impurities – Identifying potential risks to product quality.
- Validating Assays for Consistent Results – Ensuring accuracy and reproducibility in testing.
Built on a Foundation of Compliance
Afton Scientific maintains an exceptional regulatory track record, supported by:
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Successful FDA inspections and global regulatory approvals.
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A mature Quality Management System (QMS) that drives continuous improvement.
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A culture of compliance, accountability, and transparency in every process.
Tailored Filling Services to Fit Your Project
We provide customized solutions for:
- Clinical and commercial production runs with rapid turnaround.
- Flexible production schedules to meet evolving project needs.
- Custom packaging solutions designed to fit client-specific requirements.