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Preformed Trays and Blisters, Lidding and Sealing Machines Q&A

  •   Cardiac catheterisation kits contain many types of devices including sterile drapes and gowns, syringes, hypodermic needles, glass drug vials and so forth. Is there a specific guidance document that deals with this type of packaging as opposed to single-device packaging?

    To my knowledge, there is no additional guidance beyond ISO 11607-2006 parts 1 and 2. For most device companies that produce kits grouping various items and types of materials in the same outer pack, the order in which the articles are laid out inside and the level of protection that each requires will need to be defined at the design control stage.

    Whilst packaging manufacturers can give advice on layouts and constraints linked to packaging and the production process, the finished package will be assessed against the ISO standard.

  •   What material is used to make disposable fluid-barrier surgical gowns? Where can I purchase the material in bulk?

    Fluid barrier surgical gowns are made of nonwoven materials, which are usually based on polyethylene, such as DuPont Tyvek, or on polypropylene as offered by Kimberly Clark, Molnlycke and many others. A comprehensive list of possible suppliers can be found on Medical Device Link.

  •   We use legacy HPLC equipment to perform reagent identification. Is equipment used in medical device production and in a QC lab exempt from installation, operation and performance qualification?

    Laboratory equipment and reagents are not really my area of expertise, but I would say that if the equipment was previously used in medical device production, it should have undergone all three qualifications in order to be validated. This means that full validation protocols and data should be available for use as a base. You may have to rewrite the protocol for your current use but, in theory, you could revalidate the chromatography system based on the old IQ/OQ/PQ work. What I cannot say is whether your equipment should be validated for your application. If you are unsure on that and the process, I would recommend employing a suitably qualified consultant to advise you.

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