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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.

(or their equivalent ABNT standards such as ABNT NBR ISO 11135, ABNT NBR ISO 11137, ABNT NBR ISO 17665)