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Sterilisation & Cleanroom Controls

For manufacturers of sterile medical devices, RDC 752/2022 and applicable ABNT standards require:

Sterilisation process controls:

  • Validated sterilisation process (ISO 11135, 11137, 17665 as applicable);
  • Routine bioburden monitoring;
  • Parametric release (where permitted by ANVISA);
  • Sterility testing according to a validated test method; and
  • Sterile barrier validation (ISO 11607).

Cleanroom/controlled environment controls:

  • Classification of cleanrooms to applicable standard (ISO 14644);
  • Environmental monitoring (particles, microbiology);
  • Gowning procedures and personnel training; and
  • HVAC validation and ongoing certification.
Official sources

Verify all information against official ANVISA sources before making regulatory decisions.