Simplified Rapid Sterility Testing

Traditional testing methods are too slow to meet the growing demand for life-saving medicines and regulators are increasingly critical of the subjective nature of sterility result analysis. The need for rapid sterility testing equipment with enhanced data integrity and objective result generation is greater than ever before.

That's why we created the Celsis® detection platform, a proven solution designed to bring speed, objectivity, and enhanced data management to sterility testing. We've partnered with industry leaders to help QC laboratories modernize their approach without adding unnecessary complexity.

All Celsis rapid sterility testing equipment (systems, reagents, and accessories) shares the same impressive features, fluid ease-of-use, and regulatory-ready software design. With so many features in common, there’s no need to compromise when integrating a new rapid sterility test:

 

 

Intuitive →

Simple integration into your current sterility test protocols, leaving standard preparation methods intact. Adapts to current validated test methods for sterility or direct inoculation.
 

Efficient →

Eliminates days of incubation, replacing the standard 14-day traditional sterility test with a 6-day rapid sterility test.
 

Data-driven →

Obtain objective results by replacing the visual turbidity check with automated, instrument-based analysis.
 

Secure →

Enables enhanced data integrity and control through on-board, regulatory-compliant software with automated reporting and multi-user management.

 

Digitalization of Sterility Testing

As pharmaceutical manufacturing evolves under the principles of Pharma 4.0TM, sterility testing is undergoing a digital transformation. Digitalization in this context refers to the integration of instrument-based detection, electronic data capture, and compliant software systems to improve the speed, accuracy, and traceability of sterility test results. By moving away from manual processes, such as visual turbidity checks and paper-based records, QC laboratories can enhance data integrity and reduce the risk of human error. Digital sterility testing platforms like Celsis support this transition by enabling secure, automated result documentation, electronic audit trails, and scalable workflows that align with modern quality systems and regulatory expectations.

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Regulatory Alignment

The regulatory landscape has evolved to encourage the adoption of rapid microbial methods (RMMs) and digital data management practices. QC labs now have more guidance and support than ever when modernizing their sterility testing strategy.

European Pharmacopoeia (Ph. Eur.) is also updating information on this critical topic, with the aim to facilitate the implementation of Rapid Microbial Methods (RMMs). The draft general chapter was published in Pharmeuropa 37.2 which has undergone public consultation and a revised chapter is expected to be issued in 2026.

Supporting Lean Laboratories

Lean QC labs often struggle to balance routine testing with implementing new technologies. That’s where we come in. Our experts provide guidance at every step of the modernization journey, from method suitability to data integrity best practices.

Discover the approach

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Explore the Celsis® Rapid Microbial Detection Brochure
Gain insight into Celsis® technologies, platform capabilities, implementation considerations, validation support, and microbial detection applications across a range of product types.
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Frequently Asked Questions (FAQs)

  • What is digital sterility testing?

    Digital sterility testing refers to the use of software-enabled systems and instrument-based detection methods to perform sterility testing with greater accuracy, speed, and data integrity. Unlike traditional methods that rely on manual inspection and paper records, digital systems automatically record, analyze, and store test results in compliance with regulatory requirements.

  • How does digitalization improve sterility testing?

    Digitalization enhances sterility testing by reducing manual steps, minimizing human error, and ensuring that data is secure, traceable, and audit-ready. It enables automated result analysis, electronic data storage, and streamlined reporting, all of which contribute to faster decision-making and stronger compliance with standards like 21 CFR Part 11 and USP <1071>.

  • Is digital sterility testing compliant with regulatory guidelines?

    Yes. Digital sterility testing platforms are designed to meet regulatory expectations for data integrity and electronic records. Systems like Celsis include features such as user access controls, automated audit trails, and validated software to support compliance with global regulatory frameworks, including those outlined in USP <73>, USP <1071>, Ph. Eur., and EU Annex 1.