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  • 1.  Igredient as cosmetic grade, device grade, pharmacopeial grade and food grade

    This message was posted by a user wishing to remain anonymous
    Posted 29-Oct-2018 08:44
    This message was posted by a user wishing to remain anonymous

    ​​What is the difference when an ingredient/substance is said comply with cosmetic grade, device grade, pharmacopeia grade and food grade? When we say ingredient is cosmetic grade or device grade then against which formulary/standards they are compared with? Which among them can be considered of highest quality and safety standards?  Is it acceptable to use cosmetic grade ingredient in medical devices for EU/US?


  • 2.  RE: Igredient as cosmetic grade, device grade, pharmacopeial grade and food grade

    Posted 29-Oct-2018 17:06
    ​Hi Anon.

    The difference in my practical experience is usually two fold: First the grade of material usually provides some idea as to the purity and the consistency of the production process meaning it provides something meaningful when delivering specifications.  Second, the relatively safety assessments that have either been conducted by testing or by analysis of the product and its safety for use in these different types of products.

    I would personally not use a cosmetic grade material in a device that would be implanted or in some other way come in contact with sterile areas or fluids of the body generally.  As for a device that might be simply used topically (like a blood pressure system) I would critically evaluate whether or not there were other more appropriate grades of the material available for use and if there were not whether my use of the cosmetic grade of the material might impart additional safety or efficacy concerns for the device such as risk of premature failure or loss of calibration.

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Igredient as cosmetic grade, device grade, pharmacopeial grade and food grade

    Posted 30-Oct-2018 03:16
    Hi,

    As already Victor mentioned before, the difference of the various grades (pharma, food, cosmetic etc) is mainly the purity of the substance. Depending on the manufacturing process of the ingredient and its intended use, the residuals or the by-products can greatly vary between different grades. In most of the cases, pharma grade is the purest and the most expensive. But you must be careful because even between different producers of the same grade of an ingredient, the variations can be considerable (always check the specifications of the ingredient). This is mainly happening in cosmetic or food grade ingredients.

    In my personal experience from formulation of different products (devices, pharmaceuticals, devices), depending on the product and how critical is the ingredient, you can use all the grades with the proper justification. Of course there are several limitations, which I hope I can clarify in the following examples.

    For example, If you are designing an implantable device, of course you will use the purest ingredients. I cannot see a case where you can use a cosmetic grade ingredient. But on the other hand, if you design a cream (Class III) which contains an active ingredient (lets say an antimicrobial agent), the active ingredient must be pharma grade. It is good to use the purest grade in all the excipients, but there are cases where an ingredient is available only in cosmetic or food grade. Usually, the NB accept those ingredients with a reasonable justification.

    In all cases you must have in mind that no universal rule exists in these cases.
    My suggestion is to use the purest compounds possible in each case, in order to avoid future problems. If you work with materials, try to find materials that comply with the international standards (e.g. ASTM standards for metals or alloys).

    Hope this helps!


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    Spyros Drivelos
    Medical Devices Manager
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 4.  RE: Igredient as cosmetic grade, device grade, pharmacopeial grade and food grade

    Posted 30-Oct-2018 09:31
    As mentioned, check the purity and specifications provided for the various grades. Sometimes grades are designated as such by the raw material manufacturers as a marketing mechanism to fetch a premium price, although there are reasons to scrutinize the differences. With polymers, for example, a 'medical grade' versus a 'food grade' resin can mean that the medical grade undergoes USP <661.1> and <87>/<88> testing and is listed in a Type III DMF. The food grade is often times the same polymer but without the necessary guarantees, such as a legal obligation to notify of changes in a DMF (i.e., formulation changes). These non-material offerings are valuable and possibly necessary.
    At a minimum, all grades need to be produced under GMP conditions. While Procurement will push R&D to source the most practical raw materials, it helps to look through the lens of scrap costs (or even product recalls) if the selected material falls short at a later date.

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    Holly Bilinski, MS, RAC
    Ann Arbor, MI
    United States
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    Original Message


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