Aseptic Processing
for Sterile Injectables
Setting the Standard in Safety, Sterility, and Quality for Over 20 Years
What is Aseptic Processing?
Aseptic processing is the meticulous technique used to prevent microbial contamination during sterile injectable manufacturing. This highly controlled process ensures that every product remains free of harmful microorganisms throughout production and packaging.
Key Challenges & How Afton Scientific Excels
Maintaining stringent sterility through advanced isolator technology.
Minimizing contamination risks with state-of-the-art cleanroom environments.
Ensuring regulatory compliance with continuous monitoring and validation.
State-of-the-Art Technology for Uncompromising Sterility
Afton Scientific’s facilities are designed to uphold the highest sterility standards through:
- Single-use systems for contamination control and enhanced product safety.
- ISO-classified cleanroom environments exceeding regulatory expectations.
- Flexible infrastructure that supports a variety of batch and vial sizes with pre-filled syringe and cartridge filling capabilities coming in 2026.
A Legacy of Sterile Manufacturing Excellence
For over two decades, Afton Scientific has been a trusted partner in aseptic processing, delivering high-quality sterile injectable solutions with an unwavering commitment to safety, sterility, and regulatory compliance.
Our expertise spans a diverse range of products, including biologics and small molecules as well as emerging modalities like mRNA therapies. With a focus on precision and innovation, we ensure that every batch meets the highest industry standards, helping innovators bring life-saving therapies to patients with confidence.
Expertise Across Diverse Modalities
Afton’s aseptic processing capabilities extend across a wide range of therapeutic categories, including:
-
Biologics & Biosimilars
Ensuring sterility for complex large molecules.
-
Small Molecules
Supporting sterile injectable formulations with precision.
-
Specialty Injectables
Specialized expertise for highly regulated products.
-
mRNA Therapies & Emerging Modalities
Expanding capabilities to meet the needs of next-generation therapies.
Built on a Foundation of Compliance
Afton Scientific maintains an exceptional regulatory track record, supported by:
-
Successful FDA inspections and global regulatory approvals.
-
A mature Quality Management System (QMS) that drives continuous improvement.
-
A culture of compliance, accountability, and transparency in every process.
Formulation Fill/Finish Operations
With the addition of new formulation capabilities, Afton Scientific offers a seamless pathway from development to final fill/finish, providing integrated solutions for complex injectable products.