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Sterility Assurance Level (SAL) For EO Sterilization

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115 views3 pages

Sterility Assurance Level (SAL) For EO Sterilization

Uploaded by

terminatorf16
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Sterility Assurance Level (SAL) for EO Sterilization

To validate that a sterilization process achieves a required Sterility Assurance Level (SAL), typically 10⁻⁶
for healthcare products, specific tests are conducted. These tests include biological and chemical
monitoring to confirm that microbial reduction meets or exceeds the required assurance level. Here are
common tests related to SAL validation:

1. Biological Indicator (BI) Test

- Purpose: BIs provide a direct measurement of the sterilization process effectiveness by using highly
resistant spores as test organisms (usually *Bacillus atrophaeus* for EO).

- Procedure:

- Place BIs in the most challenging-to-sterilize locations within the product load, often within the
packaging or dense areas.

- After the sterilization cycle, retrieve the BIs and incubate them in a growth medium under specific
conditions.

- Observe for microbial growth over a 7-day period. A lack of growth indicates the sterility
requirement is met.

- Acceptance Criteria: For an SAL of 10⁻⁶, all BIs should show no growth after the incubation period,
confirming a 6-log reduction in the microbial population.

2. Half-Cycle Method Test

- Purpose: To confirm that the sterilization cycle achieves an overkill condition by reducing the
bioburden significantly within half the exposure time.

- Procedure:

- Run the sterilization cycle for half the validated exposure time.

- Place BIs in the load, as well as Product Challenge Devices (PCDs) that mimic the product’s
resistance to sterilization.

- Retrieve BIs and incubate them. The absence of growth in BIs even with reduced exposure confirms
that the full cycle will achieve the required 10⁻⁶ SAL.

- Acceptance Criteria: No growth in BIs after half-cycle incubation confirms overkill and supports the
effectiveness of the full sterilization cycle.
3. Bioburden Testing

- Purpose: Determine the initial microbial load (bioburden) on products before sterilization, which
helps in calculating the required sterilization dose.

- Procedure:

- Perform microbial testing on a sample of products before sterilization using methods such as
membrane filtration or direct plating.

- Count the colony-forming units (CFUs) to assess the natural microbial load.

- Acceptance Criteria: Bioburden levels should be consistent with expected levels and be low enough
that the sterilization cycle will achieve a 6-log reduction to reach the SAL of 10⁻⁶.

4. Chemical Indicator (CI) Testing

- Purpose: CIs provide visual confirmation that the product was exposed to EO gas, though they do not
directly indicate sterility.

- Procedure:

- Place CIs in various locations throughout the load.

- Run the sterilization cycle, and observe the CIs for color changes or pattern development, indicating
EO exposure.

- Acceptance Criteria: CIs should demonstrate the expected color change, confirming uniform exposure
to EO gas throughout the load.

5. Verification of Sterility Assurance Level (SAL) Through Overkill Method

- Purpose: Verify that the sterilization process achieves an overkill SAL of 10⁻⁶ by demonstrating
microbial lethality beyond the minimal reduction level required.

- Procedure:

- Place extra BIs with a high spore load (e.g., 10⁶ spores) within the load.

- Run the complete validated sterilization cycle.

- Remove the BIs and incubate in a growth medium. The goal is to achieve a complete inactivation of
10⁶ spores, validating a 10⁻⁶ reduction.
- Acceptance Criteria: All BIs must show no growth, confirming that the full sterilization cycle achieves
the SAL 10⁻⁶.

6. Microbial Enumeration Test (Post-Sterilization)

- Purpose: To check that no microbial contamination remains on the product post-sterilization.

- Procedure:

- After the sterilization cycle, perform microbial testing on the products using a validated
enumeration method.

- Acceptance Criteria: There should be no detectable microbial presence on any of the tested products,
indicating successful sterilization.

7. Endotoxin Testing (If Applicable)

- Purpose: To ensure that endotoxins (by-products of certain microbial cell walls) are not present, as
they can survive sterilization processes and cause adverse reactions.

- Procedure:

- Use the Limulus Amebocyte Lysate (LAL) test or a similar endotoxin detection method on samples
after sterilization.

- Acceptance Criteria: Endotoxin levels should be below the specified threshold, typically <0.5 EU/mL
for devices in direct contact with the bloodstream.

Conclusion

These tests confirm that the EO sterilization process consistently achieves the necessary sterility
assurance level (SAL) of 10⁻⁶, which is essential for ensuring the safety and efficacy of medical devices
like sterile latex gloves. Each test provides critical data on the process’s efficacy, with BIs offering direct
proof of microbial inactivation and CIs, bioburden testing, and other methods verifying process control
and exposure adequacy.

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