Sterility Testing
Sterility testing is a qualitative assay that aims to verify the absence of viable microorganisms on a medical device after sterilization. As a mandatory requirement for regulatory submissions (FDA 510(k), PMA, EU MDR, etc.), this test ensures that each batch of sterile medical devices meets the Sterility Assurance Level (SAL) of ≤10⁻⁶, meaning there is no more than a one-in-a-million chance of a non-sterile unit. Regulatory agencies, including the FDA, EMA, and NMPA, require sterility testing to confirm that sterilization processes are effective and that products are safe for patient use. At Meditronics (a brand of STEMart), we provide comprehensive sterility testing services that comply with global standards, helping manufacturers achieve regulatory approval while maintaining the highest levels of product safety.
Our Service
Meditronics offers method suitability and sterility testing specifically designed based on product type and regulatory requirements:
1. Method Suitability Testing
Before conducting sterility testing, we perform method suitability testing to confirm that the product does not inhibit microbial growth, which could lead to false-negative results. This test involves:
1) Spiking samples with standard strains (e.g., S. aureus, C. albicans, B. subtilis, A. brasiliensis)
2) Validating recovery of the chanllenge organisms
3) Adjusting methods if interference is detected (e.g., addition of an appropriate substance to the specificed test media, diluents or solvents, additional rinsing steps)
2. Sterility Testing
Direct Inoculation Method
Samples are directly inoculated into culture media (Fluid Thioglycollate Medium (FTM) and Soybean-Casein Digest Medium (TSB)). Ideal for non-filte products.
Membrane Filtration Method
Sample solutions are filtered, and membranes are incubated in media. Preferred method for products with antimicrobial activities.
Rapid Microbiological Method (RMM)
For time-sensitive projects, Meditronics offers Rapid Microbiological Methods (RMMs) that reduce the traditional 14-day incubation period to approximately 6 days, while maintaining equivalent reliability.
Why Choose Meditronics?
Meditronics delivers fully accredited sterility testing services that meet FDA 21 CFR Part 820, EU MDR Annex I, ISO 13485, and ISO 11737 requirements. Our state-of-the-art ISO 14644-certified cleanrooms and experienced microbiology team ensure the highest testing accuracy for all medical devices.
✔ Regulatory Expertise
Our reports are submission-ready for FDA, CE, NMPA, and other global agencies.
✔ Flexible Testing Solutions
We customize methods based on product type (e.g., liquid, solid, combination products).
✔ Advanced RMM Options
Accelerate your testing timeline without compromising accuracy.
✔ End-to-End Support
From method development to final compliance reports, we guide you through every step.
By partnering with Meditronics, manufacturers gain reliable, high-quality sterility testing data that ensures regulatory compliance and patient safety. Contact us today to discuss your sterility testing needs and streamline your product's path to market!
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