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Do we have to validate every piece of new equipment?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Apr 18, 2016.

  1. Nikki

    Nikki Well-Known Member

    Jul 31, 2015
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    Hi there,

    We are a medical plastics compounder. End users turn our beautiful pellets into life-saving medical devices.

    We are being audited like crazy, and busy is booming, which requires more resources and equipment.

    So the question is - does each new piece of equipment need to be validated?

    For example, we use pelletizers. They chop the strands of plastic into cylindrical pellets. That's it. If we buy 10 new pelletizers, do we need to validate them?

    Same question for dryers, waterbaths, feeders?

    I understand validating the extruder - as it is compounding our finished product - but does auxiliary equipment apply?

    Thank you,
  2. Eric Twiname

    Eric Twiname Well-Known Member

    Jul 31, 2015
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    Northeast USA
    I hate answering questions with questions...but I'm not immune :)

    Do your customers care about size, shape, weight, uniformity, etc. of the pellets?
    If new machine #1 cuts 1/4" long strands, and new machine #6 cuts 1/2" long strands...are both OK?

    Does drying temperature matter? Is 450C OK?
    Does waterbath temperature control matter? Is 33F OK?

    Validation of equipment can be very intense...or it can be "Yup, tried it and it worked!" (within the bounds of regulatory requirements).
    You validate your brooms...by sweeping the floor. (No, I don't think you keep records of it)

    What are the needs of your process, does the equipment meet those needs? It doesn't have to be a self-inflicted wound to be a validation.
    Nikki likes this.
  3. Ronen E

    Ronen E Well-Known Member

    Jul 31, 2015
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    From a regulatory / compliance perspective, under what schemes are you audited? What do these schemes say about validation (if anything at all)? Or maybe it's "just" your customers? (Customers are kings. If you want their business, that is.)

    Assuming that you do have to validate -

    1. Validation is normally required only where output isn't verified 100% or statistically close to that. For example, the output of a dryer can be verified instead of validating it. Is it economical / desired? Not sure.

    2. Process validation is per output characteristic. If the characteristic is not important to quality, you might get away not validating. Consider the impact of your output characteristics on end users (medical device manufacturers) processes, as inputs. "Primary" or "auxiliary" labels don't matter; what matters is how the equipment affects the end result. If your extruder is fed a moisture percentage outside its validated range, its output, in turn, won't be guaranteed. So dryers, for example, might matter.

    3. If you have multiple pieces of identical equipment (eg new machines of the same model) you only have to fully validate one and include all the rest via justification, IQ and measures to ensure that they are all installed, maintained and operated in the same manner.

    Nikki and Roberticus like this.
  4. Karl76

    Karl76 New Member

    Apr 29, 2016
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    Assuming you are extruding yourselves: If you use your pellets in a downstream process like extruding you can treat them as intermediate products (no validation) as long as you validate the downstream process they are used in.
    Else Ronens point 3 is the most efficient way to go.

    Greetings, Karl