EFHSS Questions and Answers - Question Q00205

What is the reccomendable method for performing fumigation with formaline in cleanrooms (i.e. asseptic processing, class B clean room): with formaline 37% by heating to the complete evaporation of the formaline solution or is it neccesary further dilution of formalin? I know that the optimum activity of formaline is attained at relatively high humidity, i.e. 60%.
What is the amount of formaline reccomended for cubic meter: 1-2 grams? One should know that value in order to establish the quantity of solution necessary taking into account the volume of the room.

Thank you.
Pharm. Gabriela Bodea

Dear Gabriela,

I think the answers on questions Q00067, Q00146 and Q00158 can solve your problem.

Best regards,
Wim Renders

Dear,

In theory three products can be used for surface decontamination: formaldehyde, peracetic acid, and hydrogenperoxide. There is general consensus that formaldehyde is toxic through inhalation, skinabsortion and through oral intake. Moreover it is very irritating for all mucous channels and there is risk for hypersensitivity, mutagenicity and so on. Above a level of 0,1 ppm it is very harmful for one's health. It has already been forbidden in Scandinavia and other countries are following.
As far as peracetic acid is concerned; it is explosive, it attacks certain materials, is difficult to remove via aeration, and it needs a high relative degree of humidity to guarantee sufficient activity. Moreover the process is difficult to validate.
The conclusion for both is expressed in the pun: SPRAY and PRAY.
Remains hydrogenperoxide. It is used very much since 1999 in gaseous form to sterilise clean rooms. It is very active against spores. It decomposes spontaneously into water and oxygen. It does not leave any residues. It can be used with most materials. It can e.g.be used during a nightshift.

Kind regards,
Prof Jean Paul Remon
Department of Pharmacy
Univerversity of Ghent

Dear Gabriela,

Information on the vaporised hydrogen peroxide technology (VHP), you can find e.g. on the Steris website: www.steris.com; follow: Our businesses, Healthcare, Bio-pharmaceutical production to About VHP technology.

Good luck,
Wim Renders

Dear Gabriela,

You can find more very interesting information about clean room bio-decontamination on www.bioquellpharma.com This might offer an alternative to the outdated fumigation with formaldehyde.

See you,
Wim Renders

Dear Professor Jean Paul Remon,


CPS is distributor of Curtis Dynafog (the world leading ULV and thermal sprayers, www.dynafog.com) in Vietnam territory.

I was very empressed with your message in EFHSS regarding surface decontamination. I wonder if we can use electric ULV/mister in surface decontamination or should we use residual sprayers.


Thanks for your kind attention.

With Regards



Ho Thanh Hong
Managing Director.

CPS Co., Ltd
No.33 Alley 47/4 Nguyen Hong
Dong Da, Hanoi
Vietnam