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Microbiology Testing
Lucideon offers microbiology testing - to fulfil QA / QC and regulatory requirements, to help our clients find the root cause of failures and to develop the next generation of products.
Coupled with our chemical, physical and surface analysis capabilities, the addition of microbiology testing means that we can now offer our medical device, pharmaceutical and consumer healthcare clients all the testing, analysis and development they need.
Our Microbiology Testing Services include:
- Bioburden determination to BS EN ISO 11737-1
- Bacterial endotoxin (LAL) testing
- Antimicrobial efficacy testing
- Sterility testing and validation (to Ph EUR, USP, FDA or BS EN ISO 11737-2)
- Cleanroom microbiological monitoring to ISO 14644
- Cleaning and disinfectant validation for reusable devices.
We don't just provide testing data - we also provide solutions to your materials problems throughout the product lifecycle:
- Materials development support for anti-microbial products
- Product claim support
- Failure analysis - identification of microbes as the root cause.
Case Studies
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Lucideon Helps Greatbatch Medical to Gain FDA Acceptance
Lucideon has worked with Greatbatch Medical to help them gain FDA approval.
Contact Us
Resources
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White Paper
Regulatory Approval Testing of Hydroxyapatite - The Benefits of Using One Supplier
pdf (378 KB) -
White Paper
Medical Devices - Cleanliness Validation
pdf (793 KB) -
White Paper
The Use of Imaging for Claim Support in the Personal Care and Healthcare Industry
pdf (5.92 MB)
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