 Frank Nelissen Sealed Air Nelipak Managing Director Visit Website |
Frank Nelissen has been active in the medical device industry since 1979. He bought the family-owned Nelipak business in 1982 and installed the world’s first Class 7 cleanroom to produce medical-grade trays and packaging. Nelipak rapidly became a provider of turnkey packaging solutions for the pharmaceutical and medical device industries supplying trays, lidding and blister sealing machines. Sealed Air acquired the company in 2007. Since that time, Nelissen has been managing director of Sealed Air Nelipak in Europe.
Sealed Air develops packaging and performance-based materials and equipment systems that serve an array of food, industrial, medical and consumer applications. Operating in 52 countries, Sealed Air’s international reach generated revenue of US$4.8 billion in 2008. With widely recognized brands such as Bubble Wrap brand cushioning, Jiffy protective mailers, Nelipak custom thermoformed products and Cryovac packaging technology, Sealed Air continues to identify new trends, foster new markets, and deliver innovative solutions to its customers. |
Preformed Trays and Blisters, Lidding and Sealing Machines Q&A
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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?Answered August 6th, 2009 by Expert: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.