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Class VI - USP<88> - manufacturing contact surfaces

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  • TooManyDaves
    10/03/2020 16:38
    Excuse my ignorance, I've joined a new company with subcontracted manufacturing. The subcontractor has concerns about a small PEEK connector used in downstream processing that does not have class VI certification. I've never come across this requirement previously and my limited reading is that class VI is largely a requirement of medical implants, and at most is nice to have for both storage containers and manufacturing contact surfaces. Am I misreading / misunderstanding requirements? Does anybody have a simple to digest source of information around these requirements? And how have I not come across this previously if it is so important?
  • GMP Committee response
    14/05/2020 11:37
    Reference to [USP] Class VI” is often used as a “quick” way to assess the safety of plastic components, with regards to extractables, used within manufacturing processes but is not the only means of assessment of compliance to EU GMP CH 3 section 39: 3.39 Production equipment should not present any hazard to products. Parts of production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard. Given the description of the item in question – a connector used in DSP – it seems reasonable that a risk-based approach to assessment of the component would be reasonable. The assessment should consider, for example: • general information on material of construction (can extractables be expected from the material of construction), • the aggressiveness of the solvent the product is in when exposed, • surface area the product is exposed to, length (of time) of exposure, • impact to product, • likelihood of clearance on further processing, ability to detect the extractable or impact of the extractable on the product
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