Stability Studies for
Sterile Injectables

Ensuring Product Integrity and Safety Over Time

Questions? Get in Touch

Reliable Stability Studies for Sterile Manufacturing

Afton Scientific provides robust stability testing services to evaluate the long-term safety, efficacy and shelf life of sterile injectable products. We conduct ICH-compliant studies (Q1A–Q1E) to support product quality throughout its lifecycle.

Our specialist team utilises advanced analytical techniques and modern storage capabilities to support regulatory submissions and readiness for market entry with confidence.

Tailored Stability Studies to Meet Your Requirements

Afton Scientific offers a comprehensive range of stability study services, including:

Real-Time and Accelerated Stability Studies

Assessing product performance under standard and stressed conditions.

Forced Degradation Studies

Simulating extreme conditions to predict degradation pathways.

Packaging and Container Closure Evaluations

Ensuring compatibility with packaging materials.

Advanced Stability Chambers

Our stability storage solutions provide:

  • Controlled Temperature and Humidity Conditions
    Supporting long-term, intermediate and accelerated stability studies.
  • ICH-Compliant Storage Parameters
    Ensuring alignment with FDA, EMA and global regulatory standards.
  • Real-Time Environmental Monitoring
    Continuous monitoring to support data integrity and compliance.

Comprehensive Analysis to Support Stability

Analytical testing plays a key role in stability studies by:

  • Monitoring Potency and Purity Over Time
    Ensuring therapeutic effectiveness is maintained.
  • Detecting Degradation Products and Impurities
    Identifying potential risks to product quality.
  • Validating Assays for Consistent Results
    Supporting accuracy and reproducibility in testing.

Built on a Foundation of Compliance

Afton Scientific maintains a strong regulatory track record, supported by:

  • Successful FDA inspections and global regulatory approvals.

  • An established Quality Management System (QMS) that supports continuous improvement.

  • A culture of compliance, accountability and transparency across all processes.

Learn More About Our Regulatory Expertise

Tailored Filling Services to Support Your Project

We provide customised solutions for:

  • Clinical and commercial production runs with efficient turnaround times.
  • Flexible production scheduling to support evolving project requirements.
  • Custom packaging solutions designed to meet client-specific requirements.

Why
Choose
Afton?

Proven Expertise in
Aseptic Manufacturing

With more than 20 years of experience in sterile injectable manufacturing, we bring extensive expertise across biologics and small molecules, ensuring consistently high standards of quality and sterility.

Client-Focused, High-Touch Service

Afton is built on transparency, flexibility and trust. We tailor our approach to meet the specific requirements of each project, providing hands-on support and a strong commitment to long-term success.

Regulatory Excellence

Our established Quality Management System (QMS), together with a strong FDA and international regulatory track record, ensures compliance, reliability and efficient regulatory engagement.

A Strong and Committed Team

With a leadership team in place for more than 20 years, we foster a culture of collaboration, integrity and innovation, supporting consistent service delivery and effective project execution.

Strategic Growth and Investment

Supported by a strategic investment partner, Afton continues to expand through new filling lines, isolator systems and enhanced capabilities to meet increasing commercial demand.

Learn More About Us

Partner with Afton Scientific

Our team is ready to support your pharmaceutical manufacturing objectives.

Get in Touch