Afton Scientific
Afton Scientific is a leading provider of aseptic manufacturing and fill-finish solutions for the pharmaceutical industry, with over 20 years of experience. The company focuses on delivering high-quality, regulatory-compliant sterile injectable products through innovative technology, flexible manufacturing capabilities, and a strong commitment to quality and safety. They are dedicated to expanding their capabilities and ensuring product integrity through advanced processes, rigorous quality assurance, and strategic partnerships. Afton Scientific specializes in sterile injectables, offering comprehensive services including formulation, aseptic filling, labeling, packaging, and pre-sterilized components, supporting both clinical and commercial manufacturing. The company emphasizes the importance of technology, automation, and quality systems in ensuring product safety, compliance, and efficiency.
Industries
Nr. of Employees
medium (51-250)
Products
Custom Components
Fully customizable pre-sterilized components including vials, stoppers, seals, and trays designed to streamline aseptic fill-finish processes.
Fill/Finish Operations
Comprehensive formulation and fill/finish solutions for sterile injectables, supporting clinical to commercial-scale manufacturing with advanced isolator-based technology.
Contract Manufacturing Services
End-to-end solutions for sterile injectable contract manufacturing including clinical and commercial sterile manufacturing, aseptic processing, and fill/finish services for biologics and small molecules.
Sterile Manufacturing Services
Commercial sterile manufacturing and aseptic fill-finish services built for long-term partnerships, featuring an isolator-based filling line that expands compliance and scalability.
Aseptic Processing Services
Aseptic processing and contract manufacturing services for sterile injectables, utilizing advanced isolator technology and ISO-classified cleanrooms.
Amber 2mL / 13mm Kits
Ready-to-fill kit containing amber glass vials, stoppers, and flip-off seals.
Custom Components
Fully customizable pre-sterilized components including vials, stoppers, seals, and trays designed to streamline aseptic fill-finish processes.
Fill/Finish Operations
Comprehensive formulation and fill/finish solutions for sterile injectables, supporting clinical to commercial-scale manufacturing with advanced isolator-based technology.
Contract Manufacturing Services
End-to-end solutions for sterile injectable contract manufacturing including clinical and commercial sterile manufacturing, aseptic processing, and fill/finish services for biologics and small molecules.
Sterile Manufacturing Services
Commercial sterile manufacturing and aseptic fill-finish services built for long-term partnerships, featuring an isolator-based filling line that expands compliance and scalability.
Aseptic Processing Services
Aseptic processing and contract manufacturing services for sterile injectables, utilizing advanced isolator technology and ISO-classified cleanrooms.
Amber 2mL / 13mm Kits
Ready-to-fill kit containing amber glass vials, stoppers, and flip-off seals.
Services
cGMP contract manufacturing services for sterile injectables including formulation transfer, aseptic filling and scale-up from clinical to commercial volumes.
High-precision sterile filling, stoppering, crimping and finishing for vials, syringes and cartridges with rapid changeover capabilities.
Laboratory analytical services including assay, impurity and related-compound testing, residual solvents, moisture analysis and method validation.
Design and execution of stability protocols to determine shelf life and storage conditions per ICH and regulatory standards.
QA/QC program execution, audit support, supplier qualification and preparation for regulatory inspections and filings.
Process qualification and routine media-fill testing to validate aseptic filling processes, including investigation and CAPA.
cGMP contract manufacturing services for sterile injectables including formulation transfer, aseptic filling and scale-up from clinical to commercial volumes.
High-precision sterile filling, stoppering, crimping and finishing for vials, syringes and cartridges with rapid changeover capabilities.
Laboratory analytical services including assay, impurity and related-compound testing, residual solvents, moisture analysis and method validation.
Design and execution of stability protocols to determine shelf life and storage conditions per ICH and regulatory standards.
QA/QC program execution, audit support, supplier qualification and preparation for regulatory inspections and filings.
Process qualification and routine media-fill testing to validate aseptic filling processes, including investigation and CAPA.
Expertise Areas
- Aseptic fill–finish production for sterile injectables
- cGMP facility operations and regulatory inspection support
- Quality management systems, QA/QC and CAPA processes
- Analytical testing and stability program execution
Key Technologies
- Aseptic filling and fill–finish systems
- Single-use and ready-to-use container systems
- Dry-heat and steam autoclave sterilization
- Gamma irradiation and ethylene oxide sterilization