Preformed Trays and Blisters, Lidding and Sealing Machines Q&A
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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?Answered January 20th, 2010 by Expert: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.



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.