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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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Q & A Post 2

6.22.18

Q: I currently have a 7.5 hp vacuum pump in a six pallet chamber and was thinking of converting over to a 10 hp vacuum pump? Do you think it would make a difference regarding the package integrity?

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Q & A Post 1

11.16.16

Q: What is the impact of maximum density variation when a mixed load is validated for ethylene oxide sterilization?

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Residual Ethylene Oxide

11.12.14

Is gas concentration or exposure time the greater contributor to EO residuals in medical devices?

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Water Jackets or Air Ducts?

11.05.14

The vast majority of sterilizers built in the sterilization industry over the last 50 years are equipped with water jackets for heating. Recently there have been conversation about using air instead of water. So which is better and why?

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Sterilization - Ethylene Oxide vs. Steam

10.06.14

The choice between ethylene oxide sterilization and steam sterilization is always cut and dry. Steam is extremely effective and inexpensive. However, ethylene oxide is used by industry to sterilize more than 50% of all medical devices. This blog post by Clark Houghtling, VP of Technical Sales and Marketing, responds to a recent online conversation.

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