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How to Make a Choice between Ethylene Oxide or E-Beam Sterilization

9.12.22

Medical device manufacturers choosing to sterilize their products and packaging face numerous options. One of these choices is between Electron beam (E-beam) sterilization and ethylene oxide (EO). Sometimes, the choice is easily made based on factors such as product limitations and sensitivity to radiation or heat, but at other times, either method seems suitable. In these cases, time-to-market and cost considerations might be the determining factors.

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Q&A 10

5.17.22

Someone recently told me that a minimum of 30 cycles with biological indicators (BIs) is required to validate parametric release. Is that true? I have not been able to find a requirement in any sterilization standard that requires this. Also, is there any significant difference in using a biological indicator release or parametric release?

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Q & A Post 9

2.25.22

How to Make the Choice between Ethylene Oxide or E-Beam Sterilization.

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Q & A Post 8

8.23.19

Q: What is the sterility assurance level (SAL) when performing an ethylene oxide (EO) Overkill Method qualification using the half cycle approach where 10 biological indicators (BIs) were used, tested, and there was 0 positives obtained (complete kill). Many people would say that the minimum SAL in this example would be 10-6, but it is actually greater than that.

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A look at the industrial sterilization market

6.21.19

The breakdown of industry sterilization is generally agreed to be roughly 52% ethylene oxide (EO) gas, 36% Gamma radiation, and 7% E-beam radiation. The remaining 5% are various modalities like steam, hydrogen peroxide, gas plasma, nitrogen dioxide (NO2), peracetic acid (PAA) and some others. In total, there are only about 25 sterilization methods known to mankind.

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Q & A Post 7

1.31.19

Q: What is the best way to determine EO concentration in the sterilization chamber?

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Q & A Post 6

1.07.19

Q: I'm designing a sterilization validation and, in general, a sterilization assurance system. All the products that will be sterilized were reviewed by a qualified team and only few products were shortlisted, being the most difficult to be sterilized products. Is it mandatory to select only one "Worst-case product" before entering the sterilization validation (ISO 11135:2014 annex B) or can I start the validation with more than one candidates "worst-case products"? Working with an Overkill approach, I can for example demonstrate the appropriateness of the internal PCD, comparing it with all candidate products in sublethal cycles! Is it mandatory to identify the most difficult to sterilize location within the product? How can I use this information in following validation steps? According to ISO 11135:2014 (8.6) "The PCD shall present a challenge to the sterilization process that is equivalent or greater than the challenge presented by the natural bioburden at the most difficult to sterilize location within the product". In my case I have more than one products / locations but it is possible to analyze whole product (for all candidate products) so I suppose there is no need to identify the most difficult to sterilize location.

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Q & A Post 5

9.14.18

Q: A process to sterilize a tray in a vented poly bag has been working for eight years when suddenly it doesn't. Some of the product returns with weakened and blown seals. Start with the seals......poly to poly. All seals tested OK prior to sterilization. In addition, the manufacturer states that the product hasn't changed. OK- then something must have changed at the sterilization plant. But all parameters of the sterilization are the same. Nothing's changed there either. After everything has been verified and the checklist shows no changes. Where do you go from there?

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Q & A Post 4

8.29.18

Q: What is the view of the members on maximum density variation (mass/volume) when a mixed load validation is done at a 3rd party sterilizer?

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Q & A Post 3

8.08.18

Q: How would you establish the load composition for half and full cycles, especially for dunnage pallets which do not contain BIs? I remember reading in a standard or TIR where "PVC" was mentioned as a highly adsorbing material. Accordingly it would sound like a valid approach to take pallets of maximum pallet density. Another (cheaper and easier) approach might be using random scrap material from production with maximum pallet density.

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