EO Production Batch Failure

Balachander

Starting to get Involved
#1
Hi,

We have products which undergo ETO sterilization by an outside vendor. It looks like there was a power outage and it causes malfunctioning to the software which resulted in erratic readings.

Max EO concentration (715 gm/L) was more than the required limits of 480-680 gm/L. EO gas weight was also more than the acceptable limit. But calculated value for gas concentration in the cycle by reference to the pressure differential, ΔP, between the beginning and the final EO gas injection into the chamber before the onset of the exposure was within the limits.
The vendor told us this batch is acceptable due to:
  • SAL of 10-6 was verified in the half-cycle, so there can be no question regarding efficient sterilization of the load, the exposure being double that of in the half-cycle.
  • There is a slight possibility of exposure of the load to an additional amount of EO, vendor suggests added acceleration aeration of up to 24 hours.
  • The load has been in quarantine undergoing ambient aeration in the warehouse already for an additional 72 hours.
  • The biological indicator (EPCD) results show no positive growth whatsoever.
  • The positive control shows growth as expected.

Is the justification acceptable? any thoughts on this

Thanks,
Bala
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Bala,

per ISO 11135:2014, section 9.5.4. (f) (2), calculation of the EO gas concentration is not a valid approach for designating conformance to the specified injected EO quantity.

Excessive EO will not adversely cycle efficacy / SAL - in contrast; here, you contractor is right. However, you would have to evaluate the impact of excessive EO to your residual levels and maybe, but less likely, the functionality of your device.

Some options that might help you built the case:
  • Does you vendor have objective evidence that the extended aeration is adequate to dissipate any potential excessive EO in the product?
  • Does you validation contain evidence that the extended aeration is adequate to dissipate any potential excessive EO in the product?, e.g.
    • Have you derived a residuals dissipation curve during validation of the residuals?
    • Are you reasonable far below specified residuals limits in your validation that you could conclude in a risk assessment that a limit excursion of 5% in EO concentration together with extended aeration would not lead to non-conforming product?
    • Did you employ challenges in your validation of EO residuals that would still be worst-case to the excursion you encounter?

No matter how you decide on the batch, you may want to request your supplier to initiate his CAPA process and request him to communicate back the results of his root-cause investigation, plus related corrective and preventive actions.

HTH,
 
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