ETO Sterilization Re-qualification

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ETO Sterilization Re-qualification Requirements

1. Re-qualification Frequency

•Minimum annual requirement
• At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed
• The scope of re-qualification must be determined and documented
• The review procedure shall be documented

2. Is Re-qualification Needed if No Product Changes Occur?

•Yes, re-qualification is still required

3. Re-qualification Items

•Based on certain preconditions, the following options are available:

  • Full re-qualification
  • No need for physical or microbial re-validation
  • Small-scale microbial performance validation

Prerequisites for Re-qualification

a) The following must be reviewed/tested:
b) Whether anysignificant changes affecting product sterility have occurred in:

  • Product design
  • Manufacturing/packaging materials
  • PCD (Process Challenge Device)
  • Suppliers
  • Manufacturing areas/facilities
  • Load configurations or manufacturing processes
    c)Bioburden trend analysis of products;
    d) Whethertemperature distribution studies and sterilizer operation demonstrate significant changes since last qualification;
    e) Whethertemperature distribution and recirculation checks in preconditioning chambers or aeration zones show significant changes since last qualification;
    f) Whether ETO Sterilization process history since last validation demonstrates reproducibility;
    g) Whetherchange control and preventive maintenance records confirm no equipment modifications affecting the process;
    h) Whetherno alterations to the ETO Sterilization process affecting sterility have occurred;
    i) IfETO Sterilization process specifications changed, re-qualification must include verification ofEO residue limits compliance with regulatory requirements.

Regulatory Standards

  • ISO 11135:2014 (Sec. 9.2: Requalification criteria)
  • FDA 21 CFR 211.113 (Sterilization process controls)
  • EU GMP Annex 1:2022 (Sec. 8.5: Revalidation requirements)

ETO Sterilization Re-qualification Requirements

The re-qualification shallinclude a review of chamber performance and annual engineering changes to ensure the original IQ/OQ results remain valid. The review must cover:

  • Preconditioning zone temperature/humidity profiles (if applicable);
  • Actual empty chamber humidity profiles;
  • Aeration zone temperatures (if applicable);
  • Additionally, even if process specifications are met, inspections must be triggered by:
    • Adverse trends in equipment performance,
    • Sterility failures;
    • To determine if re-validation is warranted.
  • Sterilization experts shall define the scope of requiredphysical and microbial re-validation based on review outcomes.

Critical Considerations for Sterilization Re-qualification

1. Handling Significant Changes

• Ifmajor changes are identified during re-qualification, re-execution of IQ/OQ/PQ may be required:

  • IQ (Installation Qualification): Verify modified equipment/software installation.
  • OQ (Operational Qualification): Retest impacted functional parameters.
  • PQ (Performance Qualification): Re-validate sterilization efficacy under new conditions.

2. Additional Requirements for Parametric Release

For facilities usingparametric release (relying on process data rather than BI testing):
a)Re-validation frequency: Must be performedat least annually;
b)Re-validation scope: Must includemicrobiological studies to confirm:

Situations Requiring Full Requalification (IQ/OQ/PQ):

a)Major maintenance of the sterilizer;
b)Structural, location, or environmental changes;
c)Unexplained sterility failures;
d)Changes in EO supply/delivery, diluent, or chamber load configuration.

Exemption from Physical or Microbial Re-qualification

When the following conditions are met:

  • No changes in product, packaging, equipment/services, or processes;
  • Chamber performance and engineering review are qualified;
  • Routine sterilization processes have operated reliably during the period;
    ?Professional judgment may determine that physical or microbial re-qualification isnot required until the next review.

Limited-Scale Microbial Performance Qualification

•May be required in specific cases, such as:

  • Verifying continued suitability of BIs relative to product bioburden;
  • Providing evidence that nounintended changes occurred since the previous (re)qualification study after a defined time interval.
    •General requirements (at minimum):
  • Oneshort-cycle or half-cycle run;
  • Includingtemperature and humidity measurements of sterilized items.

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