Sterile Products

Analytical testing to confirm safety, quality, and regulatory compliance

Sterile products must meet rigorous standards to ensure they are free from microbial contamination and safe for patient use. From injectables and ophthalmics to hydrogels and medical devices, every product type requires careful analytical evaluation. 

BA Sciences delivers comprehensive sterile product testing services that address sterility, endotoxin, bioburden, and stability requirements. Our methods are designed to deliver reliable results that support product release and regulatory submission. 

Sterile Product Testing Services 

Our laboratory capabilities cover the full range of sterile product testing, including: 

Sterility Testing 

Testing is performed in Grade A vaporized hydrogen peroxide (VHP) isolators within an ISO 8 environment. Using VHP isolators ensures results reflect the true sample matrix while minimizing contamination risk from the environment or operators. 

Endotoxin Testing 

Endotoxin analysis is available using all three USP <85> methods—kinetic chromogenic, kinetic turbidimetric, and gel clot. Suitability studies identify interfering or enhancing factors before analysis, and method sensitivity reaches 0.005 EU/mL. 

Bioburden Testing and Sterility Assurance Level (SAL) 

Medical device manufacturing with terminal sterilization requires close control of bioburden. Testing is performed in line with ISO 11737 to confirm microbial levels remain within the Sterility Assurance Level (SAL) defined for the sterilization method. Both validation and routine testing are supported. 

Stability Testing 

Full-service stability programs include method development and validation, ongoing sample management and storage, routine testing at each time point, data trending, and Certificate of Analysis (CoA) delivery. Studies are designed to address product-specific considerations. 

Why Work with BA Sciences 

The partner you choose for sterile product testing directly affects both development timelines and the reliability of regulatory submissions. At BA Sciences, our team combines: 

• Experience across diverse sterile product types, from parenterals to devices
• Advanced facilities and isolator technology that safeguard against contamination and ensure data integrity
• End-to-end study management, including method development, validation, and long-term stability oversight
• Commitment to compliance with USP <85>, ISO 11737, and global regulatory standards 

This combination of expertise, infrastructure, and regulatory alignment allows BA Sciences to deliver the precise, reliable data your project depends on. 

Get Started with Sterile Product Testing 

Partner with BA Sciences to ensure the quality and compliance of your sterile products. Contact us today to discuss your project needs.