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Tissue Disinfection Process Validation

Tissue Disinfection Process Validation

Validation of disinfectant or antibiotic processes for effectiveness against bacterial and fungal contaminants on tissue is an area of concern to both tissue banks, and regulatory agencies. A process validation simulates all aspects of the typical tissue processing and determines the microbiological reduction capability of the process.  Process validation can also help to optimize process steps or eliminate unnecessary steps. Nelson Labs is a leader in disinfectant and antibiotic testing for tissue process validations. We also work with customers in developing special/custom protocols for individual needs and assist in troubleshooting problems.

Applicable Standards

  • ISO 14160

Test Options

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TPV100 Tissue Process Validation Study (Microbial) Add
TPV100 - Tissue Process Validation Study (Microbial)

Study Outline

Disinfection or antibiotic process validations include the following general steps:
  • Consultation with the sponsor to ensure if they have a process established for their tissue in-house. If not, Nelson Labs can help develop a test regimen with the testing facility to establish a process validation.
  • Drafting a Validation protocol for the tissue processing

Steps for the validation protocol would include:

  • Selecting the panel organisms to be tested for the validation.
  • Selecting the methodology that  will be most applicable to test for the process validation
  • Analysis and determination of the steps that are in question for the process validation.
  • Understanding if all the steps in the process validation are necessary and therefore determining if process characterization may be an option.
  • Determining a log reduction value for the tissue process validation
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