Unit_14_-_Healthcare_Packaging

Unit_14_-_Healthcare_Packaging - Unit 14 Healthcare...

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14. 1 Unit 14 Healthcare Packaging In this unit, we will discuss pharmaceutical and medical device packaging. This will include terms, regulations, and general types of product categories. It also includes packages used for these products and the types of materials and features that are selected. This is a very detailed industry segment in packaging; if you have more interest in this topic there is a medical device packaging course (PKG 452) available. 14.1 General Information The medical product industry consists of about 1,000 companies. There are companies located in every state, with concentrations of companies in two geographical areas. New Jersey and eastern New York and Pennsylvania Northern Illinois and Indiana The medical product industry produces two primary groups of products: drugs and medical devices. Packaging of drugs and medical devices must be done carefully because failure of a product or improper administration or use of a product can contribute to injury, illness, or even death of the user. Consequently, every aspect of medical device and pharmaceutical packaging gets careful attention from package designers, regulators, users, the legal personnel of the pharmaceutical companies, and the regulatory agencies. Many pharmaceutical products are packaged in common packages like those used for food and other products. Common package forms used for pharmaceutical products include: Folding cartons o Glued shut o Plastic film overwraps Tubes o Metal o Plastic Bottles o Glass o Plastic Flexible packages o Bags o Pouches In addition, there are many specialty package forms used for pharmaceutical products, including: Sealed glass ampoules Injectibles Infusibles Unit doses (blister packs, pouches, etc.) Thermoforms o Kits
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14. 2 14.2 Definitions and Selected Terminology Pharmaceuticals - The words "pharmaceutical" and "drug" are interchangeable. Pharmaceuticals (drugs) are products or articles intended for use in dealing with disease or injury, including the treatment, cure, and mitigation of disease and disease prevention in humans and animals. There are two major categories of pharmaceutical products: o Prescription drugs, also called ethical drugs o Over-the-counter drugs, also called OTC or proprietary drugs US Pharmacopeial Convention - A group consisting of industry and academic personnel, medical practitioners, and government officials who: o Provide test standards o Establish classification systems o Conduct drug research and testing o Assist and benefit practitioners of medicine to use drugs effectively o Publish the US Pharmacopoeia and the National Formulary US Pharmacopoeia - National Formulary (USP-NF) - Experts from industry, government and academia are elected every five years to work on the publication of these standards. They are in a constant process of revision. The 1906 Food and Drug Act defined both the USP and the NF to be official compendia, thus transforming these voluntary standards into official regulations. Manufacturers must comply with the
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Unit_14_-_Healthcare_Packaging - Unit 14 Healthcare...

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