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EFHSS Questions and Answers - Answer to Question Q00138

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EFHSS - Questions & Answers - Low Temperature Sterilization - Q00138
Formaldehyde Residuals
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From: (Lebanon)   Date: 1 April 2002, 09:47 [GMT]
Subject: Formaldehyde Residuals

Dear Sirs

Good day. I have a problem when i sterilize surgical instruments in a formaldehyde sterilizer: The instruments have some formaldehyde particules on their bodies. knowing that the formaldehyde cycle is at 55 degree celcius, i just want to ask you sirs, is there any problem with the sterilizer, ot is it the type of the tablets (i use paraformaldehyde tablets with a PH 5.5 and a flash point 70 degree clecius)?
thank u for your time.

Imad MOSLEM
LEBANON

From: Wim Renders (Belgium)   Date: 5 April 2002, 21:23 [GMT]
Subject: Re: Formaldehyde Residuals

Dear,

Condensation and polymerisation of formaldehyde on instruments is often a problem of temperature, cold surfaces and/or a problem of presence of water on the load.
The maximum achievable concentration of formaldehyde in gaseous form (mg/l) above paraformaldehyde is:

  • at 50°C: 10 mg/l
  • at 60°C: 21 mg/l

I recommend you to check:

  • the theoretical concentration of formaldehyde in the chamber after sublimation,
  • the temperature in the chamber during preconditioning and sterilization,
  • the amount of water that's brought in the sterilizer on the instruments or during preconditioning.

Good luck,
Wim Renders

p.s.
I advise you also to check the reproducibility and thus the reliability of the method you're using. See also questions Q00125, Q00112, Q00077 and Q00067.

From: (Netherlands)   Date: 1 May 2002, 14:02 [GMT]
Subject: Re: Formaldehyde Residuals

Imad,

The process you describe can, in general, not be accurately controlled. Moreover, dry formaldehyde is not a very effective sterilant. Modern formaldehyde sterilisers use a combination of low temperature steam and formaldehyde (LTSF), where the feed of the sterilant can be controlled. PrEN 14180 on LTSF-sterilisers has been published and accepted. I expect the EN 14180 to go out for formal vote in Autumn 2002. This standard also describes a method to test for residual (par)formaldehyde. The test device is a filter disk. paper is known to retain a lot of formaldehyde.

Arjan van Drongelen
Dutch National Institute for public Health and the Environment (RIVM)

Any opinions expressed in the e-mail are those of the individual and not necessarily the RIVM.

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