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)
Afton Scientific
Products
cGMP Aseptic Filling and Sterile Vials
Afton Scientific provides aseptic filling services and sterile vials for pharmaceutical applications, ensuring compliance with cGMP standards.
Sterile Injectables and Aseptic Filling
The company specializes in the small-batch filling of sterile injectables, supporting both clinical trials and commercial drug production.
Ready-To-Fill® Pre-Sterilized Components
Afton offers pre-sterilized components, including vials, stoppers, and seals, ready for immediate use in sterile environments.
cGMP Lab Services
Afton provides lab services including method development, validation, and testing to ensure compliance with regulatory standards.
Filling Operations
The company supports filling operations with in-house component preparation, including vial washing and sterilization.
cGMP Aseptic Filling and Sterile Vials
Afton Scientific provides aseptic filling services and sterile vials for pharmaceutical applications, ensuring compliance with cGMP standards.
Sterile Injectables and Aseptic Filling
The company specializes in the small-batch filling of sterile injectables, supporting both clinical trials and commercial drug production.
Ready-To-Fill® Pre-Sterilized Components
Afton offers pre-sterilized components, including vials, stoppers, and seals, ready for immediate use in sterile environments.
cGMP Lab Services
Afton provides lab services including method development, validation, and testing to ensure compliance with regulatory standards.
Filling Operations
The company supports filling operations with in-house component preparation, including vial washing and sterilization.
Services
Contract aseptic manufacturing
cGMP contract manufacturing services for sterile injectables including formulation transfer, aseptic filling and scale-up from clinical to commercial volumes.
Sterile filling and fill–finish operations
High-precision sterile filling, stoppering, crimping and finishing for vials, syringes and cartridges with rapid changeover capabilities.
Analytical testing and method development
Laboratory analytical services including assay, impurity and related-compound testing, residual solvents, moisture analysis and method validation.
Stability studies and ICH-aligned stability testing
Design and execution of stability protocols to determine shelf life and storage conditions per ICH and regulatory standards.
Quality assurance, regulatory support and supplier qualification
QA/QC program execution, audit support, supplier qualification and preparation for regulatory inspections and filings.
Aseptic process validation and media-fill qualification
Process qualification and routine media-fill testing to validate aseptic filling processes, including investigation and CAPA.
Contract aseptic manufacturing
cGMP contract manufacturing services for sterile injectables including formulation transfer, aseptic filling and scale-up from clinical to commercial volumes.
Sterile filling and fill–finish operations
High-precision sterile filling, stoppering, crimping and finishing for vials, syringes and cartridges with rapid changeover capabilities.
Analytical testing and method development
Laboratory analytical services including assay, impurity and related-compound testing, residual solvents, moisture analysis and method validation.
Stability studies and ICH-aligned stability testing
Design and execution of stability protocols to determine shelf life and storage conditions per ICH and regulatory standards.
Quality assurance, regulatory support and supplier qualification
QA/QC program execution, audit support, supplier qualification and preparation for regulatory inspections and filings.
Aseptic process validation and media-fill qualification
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