Sterility Testing Consumables, Media, Instruments and Software
Sterility testing is a critical quality control requirement for GMP-manufactured products purporting to be sterile. False negative results risk releasing contaminated products, while false positives trigger lengthy and costly investigations. As regulatory expectations evolve — from pharmacopoeial compliance to digital data integrity — confidence in your sterility test results depends on more than just the test itself. Our comprehensive portfolio of sterility testing solutions is designed to meet the full spectrum of regulatory requirements, including USP <71>, the European Pharmacopoeia (Ph. Eur. 2.6.1), and the Japanese Pharmacopoeia, while supporting your laboratory's digital transformation.
Regulatory expectations around data governance have expanded significantly — QC laboratory data, including sterility testing records, is now firmly in scope of 21 CFR Part 11, EU Annex 11, and broader data integrity frameworks and subject to good document practices (ALCOA++).
Beyond data integrity, speed is increasingly critical. For short shelf-life products such as cell and gene therapies, release decisions cannot wait for the full 14-day compendial sterility test. Rapid Microbiological Methods (RMMs) based on proven technologies such as ATP bioluminescence are gaining broad regulatory acceptance, most notably with the recent introduction of USP <73>, which became effective August 2025.
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Steritest®: a complete & configurable Closed-System Sterility Testing Portfolio
Built on 50+ years of sterility testing expertise, the Steritest® System has continuously evolved to deliver smarter, safer, and more reliable closed-system testing workflows — fully compliant with USP <71>, Ph. Eur. 2.6.1, and JP <4.06>.
Our broad portfolio allows you to configure your Steritest® system to fit your sample type, packaging format, and controlled testing environment — whether in a laminar flow hood or isolator. All Steritest® NEO devices are equipped with the Velax® cutting clamp, eliminating scissors from the workflow and reducing contamination risk, and feature a 2D Data Matrix barcode (Q4 2026) on each canister for seamless integration with LIMS and ERP systems. A range of ergonomic accessories, including sampling solutions for further subculture or identification purposes, further optimizes convenience and safety at every stage of the test.
Designed to work seamlessly with M-Trace® software for full digital traceability, our portfolio includes:
- Sterility testing pumps and accessories
- Membrane filtration devices with 2D Data Matrix barcodes for LIMS/ERP integration
- Culture media, rinse fluids and solvent
- Direct inoculation method
Sterility testing with full data traceability and digital workflows
Today's laboratories are shifting toward fully digital, guided workflows where every action is recorded contemporaneously, creating a complete, end-to-end test lifecycle. Regulators require data to be attributable, legible, contemporaneous, original, and accurate (ALCOA++), and FDA 21 CFR Part 11 mandates that electronic records and electronic signatures meet strict integrity and audit trail standards.
Our digital QC solutions, the M-Trace® software & Mobile App are engineered to meet exactly these expectations: linking data from pumps, consumables, and samples into a single, auditable Master Test Record that supports faster investigations, more robust regulatory filings and ensuring full compliance with 21 CFR Part 11 and data integrity requirements (ALCOA++).
While step-by-step guidance and real-time deviation alerts increase process safety.
- Guided QC workflows with voice or on-screen instructions
- Real-time deviation alerts for immediate corrective action
- Paperless recording and review — from pump to audit trail
- Desktop & mobile app access for flexible operation
Rapid sterility testing aligned with USP <73>: from 14 days to 5 days (or less)
Based on highly sensitive ATP bioluminescence technology — now recognized under USP <73> (ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products) effective August 2025 — The Milliflex® Rapid System 2.0 enables faster release decisions for short shelf-life products such as cell and gene therapies, without compromising regulatory compliance.
The Milliflex® Rapid System 2.0 is an automated solution for the rapid detection, imaging, and quantification of viable microbial contaminants in filterable samples.
- Results in 5 days or less — compared to the traditional 14-day test
- Versatile for diverse organism types, including slow growers
- 21 CFR Part 11 compliant, with full audit trail support
- Easy handling & straightforward validation package
- Suitable for both sterility testing and bioburden monitoring
Our commitment doesn't stop at the product. From implementation to routine operation, our team of experts is here to support you at every stage of your sterility testing program.
Equipment Services:
- Installation, Qualification, and Performance Qualification (IQ/OQ/PQ) for Steritest® Symbio pumps and Milliflex® Rapid System
- Preventive maintenance and calibration services
- Consulting for system setup, workflow optimization, and regulatory readiness
Training:
- Hands-on operator training on Steritest® NEO devices, Symbio pumps, and M-Trace® software
- Application training for the Milliflex® Rapid System at our dedicated applications lab
- Regulatory-aligned training supporting USP, Ph. Eur., and 21 CFR Part 11 compliance requirements
As USP highlights, sterility testing should only be performed by personnel trained to independently conduct a microbial test — our training programs are designed to meet exactly this standard.
Related Resources
- Brochure: Sterility Testing Complete Portfolio
Our large variety of devices and pumps help you stay compliant with membrane filtration or direct inoculation methods.
- Article: Rapid Sterility Testing Method
The Milliflex® Rapid System 2.0 has been proven to be used for rapid sterility testing by the FDA’s Center for Biologics Evaluation and Research as a faster sterility test to identify microbial contamination in biologicals.
- Brochure: M-Trace® Electronic Test Record Software & Mobile App
Your Digital QC companion for trusted and efficient data traceability.
- Article: Sterility Testing Devices
Minimizing the risk of false positive and false negative results, the Steritest® NEO unit has been proven to be the most reliable filtration device available on the market.
- Article: Sterility Testing Culture Media and Fluids
Our sterility testing culture media and rinse fluids are formulated and tested to meet international standards. They provide the highest level of quality and testing confidence.
- Article: Sterility Testing Pumps
Our Steritest® Symbio pumps are designed to integrate perfectly into all testing environments. They will speed up and streamline your workflow, maximizing safety, confidence and convenience.
- Article: Sterility Testing Accessories
The Steritest® Symbio accessories are designed to facilitate your daily sterility testing work routine. To address your special requirements, accessories are available for a variety of different drug packaging configurations.
- Article: Direct Inoculation Method
Sterility testing of non-filterable samples, complying with your different direct inoculation method requirements.
- M-Trace® Software for Sterility Testing
Article: Our M-Trace® digital solution enables full traceability and regulatory compliance of your Sterility Test data.
- Poster: Complete Solutions for Complete Confidence with the Steritest® System
Complete solution for the most secure and reliable sterility testing.
- Data Sheet: Steritest® Symbio Pump and Accessories
Speed up your workflow with our Steritest™ Symbio Pumps and accessories, maximizing safety, confidence, and convenience, making reliable sterility testing even easier.
- Data Sheet: Milliflex® Rapid System
Our automated solution rapidly and accurately detects and enumerates microorganisms.
- Data Sheet: Steritest® Culture Media and Fluids
Our easy-to-use, reliable, and sterile products come in multiple configurations and volumes, ensuring accurate sterility testing.
- Article: Sterility Testing of Products with Antimicrobial Properties
Sterility testing of products with antimicrobial properties and how to prevent false negative results.
- Article: Sterility Testing of Products to be Diluted in Isopropyl Myristate
Complete solution for the most secure and reliable sterility testing.
- Data Sheet: Our Services portfolio supporting the Steritest® family
Discover our full range of professional and best-in-class Services related to our Steritest™ family.
