Microbiology & Sterility Testing
Ensuring the highest standards of microbial safety for medical innovation. EBI provides a full spectrum of microbiological services to validate your sterilization processes and guarantee product safety.
Microbiological safety is the cornerstone of medical device manufacturing. From the initial assessment of raw material contamination to the final validation of a sterile barrier, our laboratory provides the data-driven evidence required for regulatory clearance and patient protection. At EBI, we combine state-of-the-art cleanroom technology with decades of expertise to support your MDR (EU) 2017/745, FDA, and Pharmacopeial (USP/Ph. Eur.) compliance.
Core Microbiology Services
Our laboratory is equipped to handle the complex microbiological requirements of the medical, pharmaceutical, and biotech industries.
1. Sterility Assurance & Testing
Final confirmation that your product is free from viable microorganisms is a critical step for release.
- [Bacteriostasis & Fungostasis (B&F)]: Mandatory validation to ensure the device doesn’t inhibit microbial growth during testing.
- [Product Sterility Testing (USP 71)]: Validating the sterility of the final product via Membrane Filtration or Direct Transfer.
- [Steam Sterilization Validation]: Verification of your IFU (Instructions for Use) parameters for reusable devices.
2. Contamination Control (Bioburden)
Quantifying the microbial challenge before sterilization is essential for process validation.
- [Bioburden Validation (ISO 11737-1)]: Determining the microbial population on or in a product.
- [Recovery Efficiency Testing]: Proving the effectiveness of our extraction methods for your specific device.
3. Pyrogen & Endotoxin Detection
Protecting patients from non-microbial fever-inducing substances.
- [Bacterial Endotoxin Testing (LAL)]: Rapid, quantitative detection of Gram-negative bacterial remnants using the Kinetic Chromogenic.
- Material-Mediated Pyrogenicity: Assessing devices for chemical-induced pyrogenic responses.
4. Packaging & Shelf-Life Validation
Ensuring the sterile barrier remains intact from the cleanroom to the operating room.
- [ISO 11607 Package Validation]: A suite of tests including Seal Strength, Dye Migration, and Bubble Emission.
- [Accelerated Aging (ASTM F1980)]: Simulating years of shelf-life in controlled environmental chambers.
5. Reprocessing Validation
Supporting the safety of reusable medical equipment.
- [Cleaning Validation]: Verifying the removal of organic soils (Manual & Automated).
- [Disinfection Validation]: Confirming log-reduction of pathogens for critical and semi-critical devices.
Why Partner with EBI Laboratories?
- ISO 17025 Accreditation: Our microbiology labs operate under a strict quality management system, ensuring that every result is accurate and internationally recognized.
- Cleanroom Excellence: All sterility testing is performed in high-grade, controlled environments to eliminate the risk of laboratory-induced contamination.
- Tailored Study Designs: We don’t believe in „one size fits all.” Our experts design protocols based on your specific material, geometry, and sterilization method.
- Regulatory Support: We provide comprehensive reports that are directly uploadable to your Technical File for Notified Bodies and the FDA.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Microbiological Safety & Testing
What is the difference between Bioburden and Sterility testing?
Bioburden testing is performed on non-sterile products to count how many microbes are present. Sterility testing is a „pass/fail” test performed on the final, sterilized product to ensure no microbes survived the process.
Why are validation studies (like B&F or Recovery) necessary?
Standard tests can be „fooled” by the materials of the device. Validation proves that our testing methods actually work for your specific product, ensuring that a „negative” result is a true reflection of sterility.
Which standards do you follow?
We primarily follow ISO (e.g., ISO 11737, ISO 17665), USP (e.g., <71>, <85>), and AAMI standards, ensuring our data is accepted globally.
What is the difference between Bioburden and Sterility testing?
Bioburden testing is performed on non-sterile products to count how many microbes are present. Sterility testing is a „pass/fail” test performed on the final, sterilized product to ensure no microbes survived the process.
Why are validation studies (like B&F or Recovery) necessary?
Standard tests can be „fooled” by the materials of the device. Validation proves that our testing methods actually work for your specific product, ensuring that a „negative” result is a true reflection of sterility.
Which standards do you follow?
We primarily follow ISO (e.g., ISO 11737, ISO 17665), USP (e.g., <71>, <85>), and AAMI standards, ensuring our data is accepted globally.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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