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X-Ray Diffraction (XRD) Analysis

  •  Qualitative Phase Identification
  • Quantitative Phase Identification (%)
  •  Crystallinity (%)

Please contact us for more information. info@medbone.eu 

Microbiology

Environmental Monitoring

Environmental monitoring of cleanrooms or controlled environments is a critical process. By monitoring the manufacturing environment from a microbial perspective, reduces the risk of possible sterilization failures is reduced.

The control of microbial contamination in controlled areas is expected to meet the requirements of ISO 14698. The microbiological monitoring includes passive air monitoring using settle plates, monitoring of the surfaces and garment using contact plates and analysis of water and detergents.

Bioburden Testing

Bioburden testing is performed on medical devices prior to sterilization to determine the number of micro-organisms on the product, according to ISO 11737. A validated method must be performed, setting/establishing alert and action limits to demonstrate continued control over the process.

Please contact us for more information. info@medbone.eu

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