Healthcare & Medical Microbiology
Testing medical
products and coatings for safety and antimicrobial performance.
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Healthcare & Medical Microbiology
Orion Microbiology provides specialized testing and validation services for the healthcare and medical device industries. We support manufacturers, developers, and private providers in ensuring that their products and environments meet the highest microbiological safety standards and regulatory requirements.
Our laboratory offers a blend of routine monitoring and bespoke research, delivering the technical data required to bring medical innovations to market and maintain safety in clinical settings.
Our Specialized Services
- Medical Device & Materials Testing: We evaluate the antimicrobial efficacy and bioburden of medical devices, wound dressings, and biocompatible materials. Our studies help validate product claims under realistic usage conditions.
- Antimicrobial Surface Validation: Testing of innovative coatings and treated surfaces used in healthcare environments to determine their effectiveness in reducing microbial colonization over time.
- Water Safety & Decontamination: Specialized analysis of water systems used in medical processes, including dental unit waterlines (DUWLs) and washer-disinfectors, ensuring compliance with HTM guidelines.
- Disinfectant & Sanitiser Evaluation: Rigorous testing of chemical disinfectants and hand hygiene products against a spectrum of bacteria, fungi, and viruses (EN 1276, EN 1650, EN 14476).
Regulatory Standards & Technical Frameworks
We ensure your products and processes are tested against the relevant international and national standards, providing the robust data necessary for technical files and regulatory submissions.
| Service Category | Standard Reference | Key Analytical Targets |
|---|---|---|
| Product Bioburden | ISO 11737-1 | Total Aerobic Count Yeasts & Moulds |
| Surface Efficacy | ISO 22196 / ISO 21702 | S. aureus E. coli Viral reduction |
| Water Quality | HTM 04-01 / HTM 01-05 | Pseudomonas Legionella TVCs |
| Chemical Disinfectants | EN 13727 / EN 13624 | Bactericidal activity Fungicidal activity |
| Cleanroom Monitoring | ISO 14644 | Passive Air Sampling Active Air Sampling |
Regulatory Standards & Technical Frameworks
We ensure your products and processes are tested against the relevant international and national standards, providing the robust data necessary for technical files and regulatory submissions.
| Project Type | Focus Area | Deliverable |
|---|---|---|
| Efficacy Studies | Novel antimicrobial technologies | Quantitative log reduction data |
| Contamination Control | Identifying sources of persistent flora | Genomic identification & root cause analysis |
| Stability Testing | Shelf-life of sterile medical products | Periodic bioburden & barrier integrity |
| Process Validation | Cleaning and sterilization cycles | Evidence-based performance reports |
The Orion Advantage
- Bespoke Testing Programs: We don’t believe in a one-size-fits-all approach. We design study protocols that specifically reflect your product’s intended use.
- Interpretive Reports: Our technical team provides clear, actionable insights alongside raw data, helping you navigate complex regulatory landscapes.
- Fast Turnaround Times: We prioritise efficiency to support your R&D cycles and supply chain requirements.
- ISO & EN Compliance: All testing is performed using validated methods to ensure your results are accurate, reproducible, and ready for audit.