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Tissue Process Characterization

Tissue Process Characterization

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 characterization and/or 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 custom protocols for individual needs and assist in troubleshooting problems.

Applicable Standards

  • ISO 14160
  • AATB Standards for Tissue Banking- 13th Edition

Test Options

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

Study Outline

An important first step in process validation is process characterization.  This step helps a tissue bank to understand the capability of a process step.  There are often variables in each process step which should be understood in order to establish routine parameters (e.g. variability in temperature, concentration and time).  Process characterization is the proper venue for establishing those parameters and for optimizing the process steps if needed.

The data obtained in process characterization are used to establish the process validation approach.  Performance of a thorough tissue process validation should result in an understanding of not just which types of microorganisms are permitted on tissue which will be processed, but also how many microorganisms are acceptable.

Disinfection or antibiotic process validations include the following general steps:

  • Consultation with the sponsor to learn their tissue process and understand what data are currently available for the process.  Determine what amount of process characterization is needed (if any) prior to the process validation. Nelson Labs can help develop a test regimen for process characterization and the process validation.
  • Drafting a validation protocol for the tissue processing

Steps for the validation protocol would include:

  • Selecting the panel of microorganisms to be tested.
  • Selecting the test methodology that will be most applicable for the process validation
  • Determining the process steps that are in question for the process validation.
  • Understanding if all the steps in the process are necessary for the validation and determining if process characterization is necessary first.
  • Determining a target log reduction value for the tissue process validation
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