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Perfect Medical Device Packaging

The medical device packaging industry involve many disciplines including material manufactures, material converters, device manufacturers, educational institutions, package testing facilities and test equipment and medical packaging equipment manufacturers.

There is more to medical device packaging than simply creating a flashy package that gets consumers’ attention. It is important for Medical device manufacturers to realize that the packaging for their devices is as important as the product. If the integrity of the package and sterility of the device is violated, the device is useless.

With the continuing growth of the Medical Device Industry, the need for sterilizable packaging, barrier packaging and other packaging requirements for medical/ surgical products is increasing. With increased performance requirements, medical packaging converters and material suppliers are faced with challenges to provide products to satisfy these needs.

National And International Packaging Standards such as ISO 11607-1; ISO 11607-2; etc, Regulatory Compliance, Accelerated Aging, Package Failure Analysis are amongst the issues important for the Medical Device Industry to understand.

Packaging has to help reduce hospital acquired infections, which requires packaging that maintains its integrity, withstands sterilization, and protects against damage to expensive devices. The main objective is that the device package should protect the device during handling and shipping and from the environment and microorganisms until the package is opened.

Fulfilling the other essentials, it should also include using the most appropriate packaging materials available for the device. For selecting the right material for packaging, the following factors must have been considered: Temperature, Adhesives, Moisture resistance, Package porosity, Thermal capacity, Cling resistance, Pressure, Device size and shape, Device composition, etc.

Issues, particularly breakage of primary containers, have been reported that have resulted in recalls when either the primary container or the device constituent interact, or when the patient interacts with the delivery system.

Not only are the materials used to pack devices becoming stronger, thinner, more protective and more flexible almost by the year, but the medical device regulators around the world are starting to agree on international standards for the packaging of medical devices. These standards will not only cover the actual packaging and labeling, they will also set out standards for testing the efficacy of the packaging and the methods used to produce it.

To produce package, the physical protection is achieved through use of sufficiently rigid or protective package structure that can withstand physical and thermal demands while producing package.

Medical Packaging quality, standards, how to choose the right materials, Selection criteria for deciding right material, Emerging global trends in packaging material combinations, Cost reduction without compromising the quality, Regulations and Compliances, Availability of right quality materials, Regulations and Compliances required for Medical Packaging, Industry Standards, Physical, thermal & environmental demands, Equipment qualification required, Effective test methods, etc. are the very important things to be kept in mind while manufacturing the medical package.

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