Analytical Testing for
Sterile Injectables
Ensuring Precision, Safety and Compliance at Every Stage
Reliable Analytical Testing for Sterile Manufacturing
Afton Scientific delivers industry-leading analytical testing services to support sterile injectable manufacturing. Our robust and compliant testing methods help maintain product integrity from early development through to commercial production.
With extensive regulatory expertise and a strong focus on precision, we deliver reliable analytical data aligned with global quality and safety standards.
Analytical Testing Services
Our analytical services include:
Potency Testing
Quantifying active pharmaceutical ingredients to support accurate dosing.
Purity and Impurity Analysis
Identifying and characterising impurities in line with regulatory standards.
Sterility and Endotoxin Testing
Confirming product sterility to safeguard patient safety.
Particulate Matter Analysis
Assessing injectable solutions to prevent contamination risks.
Advanced Solutions for Complex Products
Afton Scientific applies analytical techniques specifically developed for complex sterile injectables. We support testing requirements for combination devices using universal testing instruments to define and validate critical device performance parameters:
- HPLC (High-Performance Liquid Chromatography)
For precise analysis of biologics and small molecules. - GC (Gas Chromatography)
For detecting and quantifying volatile compounds. - UV-Vis Spectroscopy
For accurate concentration measurement. - CCIT (Container Closure Integrity Testing)
Including vacuum decay, oxygen headspace analysis and other non-destructive methods to verify container closure integrity. - Microbiological Testing
Ensuring sterility and contamination control. - Adding SKAN Spectra Sterility Testing Isolators
Enhancing isolator-based sterility testing in line with evolving regulatory requirements.
Customised Method Development and Validation
Our specialist team supports:
- Tailored Analytical Method Development
Developing reliable testing methods to meet specific product requirements. - Seamless Method Transfer
Supporting consistency from development through to production. - Regulatory-Compliant Validation
Aligned with FDA, ICH and global submission requirements.
Built on a Foundation of Compliance
Afton Scientific maintains a strong regulatory track record, supported by:
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Successful FDA inspections and global regulatory approvals.
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An established Quality Management System (QMS) that supports continuous improvement.
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A culture of compliance, accountability and transparency across all processes.
Tailored Filling Services to Support Your Project
We provide customised solutions for:
- Small-batch clinical production runs with efficient turnaround times.
- Flexible production schedules to support evolving project requirements.
- Custom packaging solutions designed to meet client-specific requirements.