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Qualification of HVAC system

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Abdullah, Dec 27, 2015.

  1. Abdullah

    Abdullah Member

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    Dear All,

    Regarding the Qualification of HVAC system; any one has a template for a qualification protocol of HVAC system ?!!
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Good day Abdullah,

    What are you qualifying for? Cleanliness of air in a production room for medical instrument production and/or packaging? (just a guess)
     
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  3. Abdullah

    Abdullah Member

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    Yes jennifer, the qualification will be for a cleanliness production area that is separated from packaging area (for strips cutting and primary packaging room)
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Clean room certification is done per requirements described in Code of Federal Regulations Title 21. The ISO 14644 standards give additional specifics and guidance.
     
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  5. Abdullah

    Abdullah Member

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    thanks a lot Jennifer :)
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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  7. Abdullah

    Abdullah Member

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    thank you very much Jennifer, and i Hope you the best ^_^
     
  8. Candi1024

    Candi1024 Well-Known Member

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    Just to note, we call our "clean room" an environmentally controlled room. Often when the term clean room is used, it infers a sterile clean room, whereas ours is used to reduce airborne particles (dust, fibers) that could damage our product.
     
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  9. Abdullah

    Abdullah Member

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    Candi, what should we call an environmentally controlled room (Temperature, Humidity and airborne particles) on the the other hand; what could make a sterile clean room distinguishable rather than environmentally controlled room ?
     
  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    There are different levels of allowable airborne particulates in classification of clean rooms. If you had two rooms, both with environmental controls for maintaining certain levels in humidity, temperature and airborne contaminants (for example, one for production and first-layer bagging and the other for secondary bagging before sending to packaging), they could both be called clean rooms. They could be distinguished by calling them what they are for: e.g., "production" and "bagging 2." Or you could call them by their classification: "Clean room 100" and "Clean room 1,000."

    If, that is, you have determined it is appropriate to have two levels of control.

    In semiconductor they are simply called "clean room." What you call them matters only if you need employees to remain aware of garmenting and entry restrictions. What really matters is the control.
     
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