Analytical Testing for
Sterile Injectables
Ensuring Precision, Safety, and Compliance at Every Step
Reliable Analytical Testing for Sterile Manufacturing
Afton Scientific delivers industry-leading analytical testing services to support sterile injectable manufacturing. Our rigorous and compliant testing methods ensure product integrity from early stages through commercial production.
With deep regulatory expertise and a commitment to precision, we provide reliable analytical data that meets global quality and safety standards.
Analytical Testing Services
Our analytical services include:
Potency Testing
Quantifying active pharmaceutical ingredients to ensure proper dosing.
Purity and Impurity Analysis
Detecting and characterizing impurities to meet regulatory standards.
Sterility and Endotoxin Testing
Confirming product sterility to safeguard patient safety.
Particulate Matter Analysis
Evaluating injectable solutions to prevent contamination risks.
Advanced Solutions for Complex Products
Afton Scientific employs analytical techniques specifically designed for complex sterile injectables. We support testing requirements for combination devices using universal testing instruments to define and validate critical device performance metrics:
- 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 measurements.
- CCIT (Container Closure Integrity Testing) – Including vacuum decay, oxygen headspace analysis, and other non-destructive methods for verifying container closure integrity.
- Microbiological Testing – Ensuring sterility and contamination control.
- Adding SKAN Spectra Sterility Testing Isolators – Enhancing isolator-based sterility testing in alignment with evolving regulatory expectations.
Customized Method Development and Validation
Our expert team supports:
- Tailored Analytical Method Development – Creating reliable testing methods to meet specific product needs.
- Seamless Method Transfers – Ensuring consistency from development to production.
- Regulatory-Compliant Validation – Meeting FDA, ICH, and global submission requirements.
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:
- Small-batch clinical production runs with rapid turnaround.
- Flexible production schedules to meet evolving project needs.
- Custom packaging solutions designed to fit client-specific requirements.