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EFHSS - Questions & Answers - Low Temperature Sterilization - Q00678
Formalin gas Manufacture by CISA
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From: (Brazil)   Date: 17 November 2004, 16:04 [GMT]
Subject: Formalin gas Manufacture by CISA

Many hospital in Brasil are using this kind of sterilization.
We don't have Norm about Formalin ou LTSF?
Would you share your experience with us?
European Hospital use Formalin or LTSF?
How you do the parametric release?
Why you use Formalin gas or LTSF?
What kind Biological Indicator are used?

From: Josy Holdener (Switzerland)   Date: 11 December 2004, 19:27 [GMT]
Subject: Re: Formalin gas Manufacture by CISA

Dear Maria

The sterilization method of Low-Temperature Steam with Formaldehyde (LTSF) is used in some countries in Europe and Asia - but is almost abandoned in the USA, Canada and Australia. That might be the reason why no ISO Standards exist. EN 14180 specifies requirements and tests for LTSF sterilizers, using a mixture of low temperature formaldehyde as sterilizing agent and are working below ambient pressure.
The LTSF system has some advantages e.g., the cycle time is faster than that of ETO and the cost per cycle is relatively low.
ETO is more penetrating and can be operated at lower temperature than LTSF.
The safety issues of LTSF are similar to ETO. Formaldehyde is less toxic than ETO, but is a potential human carcinogen.

LTSF work comparable to a prevacuum steam sterilizer but at negative pressure with sub-atmospheric steam at 48°C or 60°C.
The performance of the sterilizer is satisfactory if the temperature record is within acceptable level, the process variables within limits that have been established during commissioning and no mechanical anomalies are observed.
The biological test is Bacillus stearothermophilus. There are internal and external chemical indicator specially for formaldehyde available e.g. Brown Co.
Most existing sterilization methods basically remained unchanged over the years, but the efficiency and performance of medical instruments are changing and the involved materials that have to be sterilized. Therefore it is important to know the changes and directions sterilization technology is taking e.g. Plasma and Ozone sterilizers.
Maria, I hope I have some of your questions answered!!

Kind regards
Josy

From: (Brazil)   Date: 26 January 2005, 00:49 [GMT]
Subject: Re: Formalin gas Manufacture by CISA

Josy
Thanks! I really want know if you have information about sterilizer with formalin tablets. It's manufactured by CISA in Brasil. CISA inform that's is very used in Europe. How many countries in Europe use this kind of sterilization? How many hospitals have sterilzer with FORMALIN TABLETS?
I only found articles and informations about LTSF.
I agree with you about the changes and directions sterilization technology is taking. I worked with Sterrad for ten years.
Best regards

From: Josy Holdener (Switzerland)   Date: 26 January 2005, 14:46 [GMT]
Subject: Re: Formalin gas Manufacture by CISA

Cara Maria
There are no recognized procedures or guidlines for the use of formalin tablets as steriliant, neither in Europe nor in North America.
Simply because it is NOT a Sterilization Method for medical supply used in hospitals.
Please do require written facts/references directly from the Manufacturer CISA to clarify this issue.
Kind regards
Josy

From: Josy Holdener (Switzerland)   Date: 26 January 2005, 14:55 [GMT]
Subject: Re: Formalin gas Manufacture by CISA

Adding: I just saw that a similar question (Q00166) was answered by Wim Renders.

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