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Medical Device Packaging Standard










Packaging industry leaders and pharmaceutical product marketers now have to overcome many hurdles caused by a high level of regulations imposed on the industry. Changes in packaging materials, medical packaging specifications or simply nomenclature are synonyms for increased cost and staff allocations, which add to the overall price of the drug and do not bring much value to consumers or pharmaceutical marketers.

The regulated environment is necessary to assure consumers that the drugs they use are safe and exhibit all the properties claimed by the manufacturers. The impact of these internal costs on the pharmaceutical industry often freezes the implementation of new packages at the gate. It is only with the introduction of a new over-the-counter (OTC) or prescription drug that packaging marketers and developers have an opportunity to incorporate new technologies in materials and function.

Too often, the pharmaceutical industry turns to the standard packaging method of bottles and threaded caps, without exploring the best way a drug could be packaged from the user's point of view. On the other hand, the food and personal care industries spend a lot of time, energy and money developing packages that respond better to the consumer's preference: mayonnaise is now available in an upside-down bottle with a dispensing cap; most body washes, because of their texture, are also packaged in upside down dispensing systems; and many snacks are prepackaged in small pouches for children's lunches. These are only a few examples.

As the economy continues evolving towards complete globalization, we will see drugs filled and packaged in Europe, for example, launched in the US. The way Europeans package analgesic is quite different to the US. Blisters are used in 80% of packaging in the European pharmaceutical market but in only 20% of the packages in America. Blisters do not offer the SF/CR compliance required in North America; new packaging methods will have to be developed. Europeans have not yet developed any rules or specifications that marketers have to comply with, but discussions have been on-going between the industry and regulatory bodies all over Europe and even Asia. This dialog will create the need for ideas and innovations from packaging professionals worldwide.

Medical Device Packaging Standard It is not automatic that European standards will match those in North America; it would be quite surprising if European drug marketers favor North American packaging methods. Europe has always been many micro-markets very close geographically; now it is one big marketplace but retains many geographical and, more importantly, cultural differences. These micro-markets are serviced by many creative packaging companies that are still very active and alive today, all looking at the opportunities the EU has created. North America's mass-market, standardized, low-cost approach might not be the way the rest of the world sees as the best to market products, and their choice of packaging might be quite different to comply with CPSC regulations. Vocabulary.

Download:
FDA Design Control Guidance for Medical FDA Design Control Guidance for Medical
The EU Medical Device Directive The EU Medical Device Directive
FDA Medical Device Quality Systems FDA Medical Device Quality Systems



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