Sterility Assurance Learning Hub

Your source for SAL, hydrogen peroxide decontamination, and biodecontamination validation best practices.

Ensuring true sterility in pharmaceutical, biotech, biosafety, and cleanroom environments requires more than routine disinfection. It requires a deep understanding of Sterility Assurance Levels (SAL), validated Biological Indicator (BI) inactivation, and real-world performance through Disinfection Efficacy Testing (DET).

The CURIS Sterility Assurance Learning Hub brings together expert resources to help teams understand, validate, and optimize their contamination-control programs.

🌟 Featured Articles in This Series

1. Understanding Sterility Assurance Levels (SAL)

Learn what SAL represents, how SAL 10⁻⁶ is validated with Biological Indicators, and why SAL is essential for GMP, Annex 1, and aseptic manufacturing.
🔗 https://curissystem.com/resources/blog/understanding-sal

2. Role of Hydrogen Peroxide in Biosafety & Cleanroom Decontamination

Explore why hydrogen peroxide (VHP/HHP/VPHP) has become the preferred contamination-control chemistry in pharmaceutical cleanrooms, BSL facilities, and Cell and Gene Therapty (CGT) suites.
🔗 https://curissystem.com/resources/blog/role-of-hydrogen-peroxide-in-biosafety

3. How CURIS Achieves SAL 10⁻⁶ Through BI Validation and DET Testing

Dive into CURIS’s validated results with Geobacillus spores, 10-log viral reduction, and whole-room decontamination strategies for real-world SAL performance.
🔗 https://curissystem.com/resources/blog/how-curis-achieves-sal-10-6

🧪 Why Sterility Assurance Matters

Sterility assurance underpins:

• Pharmaceutical manufacturing

• Cell & gene therapy (CGT)

• Biologics production

• BSL-2, BSL-3, and ABSL operations

• Aseptic fill-finish isolator decontamination

• Vivarium decontamination

• GMP changeover sanitation

Validated SAL programs protect product integrity, prevent contamination events, and support regulatory compliance across FDA, EMA, and Annex 1 expectations.

⚙️ How CURIS Supports SAL and Biosafety Validation

CURIS provides:

• SAL 10⁻⁶ Biological Indicator validation

• Broad-spectrum DET viral inactivation (>10-log)

• Whole-room HHP™ and vaporized hydrogen peroxide (VHP) decontamination

• OEM integrations for isolators and production equipment

• Portable and facility-scale decontamination platforms

Our Hybrid Hydrogen Peroxide™ and Rapid Vapor™ technologies are trusted across BSL-3/4 facilities, pharmaceutical manufacturers, aseptic environments, and OEM partners worldwide.

🔗 Build Your Sterility Assurance Program

Explore more resources or contact us for validation support:

→ Request a consultation
→ View CURIS decontamination systems
→ Access technical papers and studies