February 6, 2012

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Cleanroom Standards

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USP 797, BioPharmaceutical, EUGGMP, I.E.S.T., I.S.O., ASTM F1670, ASTM F1671, Federal, Pharmaceutical, FDA

Standard for hospital? (2 posts)

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  • Avatar Image said 1 year, 7 months ago:

    I’m presenting the needs of filtration in OR and ICU for our customers. They don’t have any SINGLE filtration unit or system in those rooms!!

    I did particle counting for them and trying to show that the particle count numbers are very high.

    However, I need some standard supporting this, otherwise my numbers are useless.

    So, is there any standard relating level of particle counted in hospital, i.e, OR, ICU ?
    (I do know there are some standards about air change rate but not the number of counted)

    Thanks in advance.

  • Avatar Image Bill Johnson said 8 months, 3 weeks ago:

    If I was the one being operated on in the OR I would want to have a laminar flow cleanroom area Class 1/ISO Class 3. I would want all air HEPA filtered and I would also want to UV treatment of all airflow.

    Unforunately most of the OR rooms I have seen have an air handling unit which has limited filtration and if your lucky has HEPA filters in the unit. I have seen some with UV Treatment of the air, but on a very limited basis.

    So particles counts are in the 100Ks up to the Millions. This is why most OR areas pre-treat the patient with antibiotics, just so people can survive the surgery.

    We would be glad to review your particle counts and provide recommendations at designbuild@digitalaircontrol.com

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