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  • HVAC - Clean rooms?

    ronvieky

    ronvieky

    @ronvieky-RmIqBm
    Updated: Nov 27, 2025
    Views: 1.2K
    Hi. I've got a big problem. I recently graduated in mechanical engineering, and joined a Medical device manufacturin company.

    I wish to know, what are the requirements of a Medical device clean room facility - ISO class 10,000 and 100,000. CFM, FPM, and other specifications.
    We've hired a professional consultant, but since i'm still a trainee, and this does not come under my job profile, i am unable to approach him directly. He stays out of town, and comes over once a month. Rest everything is either over phone or email.

    How to calculate duct sizing? How to select the right AHU.

    i don't want to design any of it. I just want to understand how to get the maximum out of the consultant, to be able to actively participate in the process with my senior (who's not a mech engg), so i do feel a bit anxious to take charge and take over the project. Can anyone help?

    Thanks.
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  • initd

    MemberJul 1, 2009

    Hey ronvieky,

    You may want to check out the literature at contec's site:

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  • gohm

    MemberJul 2, 2009

    I've done a lot of HVAC so would be glad to help with any questions. I don't understand why you can't arrange a time to speak with the consultant when it is convenient for them? As you say you are not involved with the project and are just seeking general knowledge for you personally. How about the project manager? there are also some internet and book resources as well.
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  • beatrice cooper

    MemberNov 27, 2025

    Clean room requirements can feel intimidating when you’re just getting started, especially in medical device manufacturing where ISO 7 (10,000) and ISO 8 (100,000) standards are strict about airflow, particle counts, and pressurization. You don’t need to design the system yourself, but having a baseline understanding will help you get more out of your consultant and feel more confident working alongside your senior.

    A good starting point is asking the consultant for a simple airflow diagram showing CFM, number of HEPA filters, and the pressurization cascade. Even a quick visual helps you understand why certain decisions were made. When you get the chance, ask how they calculated CFM and air changes per hour, most designs factor in ISO guidelines, occupancy, equipment heat load, and desired recovery time. For AHU selection, you can focus on the reasoning rather than the calculations: filtration stages, humidity control, temperature stability, and redundancy often drive the choice.

    Since clean rooms rely heavily on proper maintenance, many facilities use specialized services like RMS Cleaning because they understand how surface contamination affects particle counts. Their local listing here: https://maps.app.goo.gl/Zc6wizZ5c1oSpfMK7, gives a good example of the type of controlled-environment support available.

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