How does J-Pac perform a cleaning validation?

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J-Pac uses approved protocols for all validations, including cleaning. The medical device cleaning validation is designed to show that contaminants that come in contact with the product during manufacturing and packaging are safely removed. These contaminants include organic residues (such as oil), inorganic residues (such as leftover particulates from processing), and microbiological contaminants (such as bioburden from inadequate operator hygiene controls).

The key components of the validation are:

  1. Process FMEA to determine possible sources of contaminants, including suppliers that touch the device
  2. Benchmarking non-cleaned parts
  3. Establishing acceptance criteria
  4. Grouping of samples by material type/family, cleaning process
  5. Identification of worst-case conditions to test
  6. Establishing a statistically rationale sample size
  7. Establishing the cleaning process steps and parameters
  8. Post cleaning testing
  9. Establishing Alert and Action Levels
  10. Establishing post validation sampling plan and change control plan