tIps and InsIghts for selectIng a pharmaceutIcal BlIster packagIng fIlm
IntroductIon Blister packaging offers many options to protect the pharmaceutical products that we use. This article presents information to product brand owners and packaging engineers to satisfy some of the most common regulations and outlines some of the most pertinent technical characteristics needed from a film for package functionality and successful processing. As innovations continue and new films enter the market, a thorough understanding of how regulatory, package performance, and film attributes fit together should help ease the selection process and, hopefully, provide some framework to avoid potential problems throughout the life of the pharmaceutical product.
regulatIons and guIdelInes Regulations for pharmaceutical packaging exist in order to address safety concerns. A pharmaceutical packaging film should comply with at least the following set of regulations and also satisfy the criteria outlined in the various guidelines. For example, knowledge of technical attributes of a film, such as moisture vapor transmission rate, carries relevance when satisfying sets of guidelines such as those established by U.S. Pharmacopoeia or CDER, especially with regard to controlling changes. This list, although not entirely comprehensive, presents a starting point for federal, state, and local level types of regulations.
• U.S. Federal Food, Drug, and Cosmetic Act (FDA Title 21 CFR) o Food additive sections (e.g. § 174, 175, etc.) o Part 201 Food Allergen Act (21 U.S.C §321) o Part 211 current Good Manufacturing Practices • U.S. Generic Drug Enforcement Act of 1992 Section 306 (Debarment Compliance) • European Regulations and Directives o 1935/2004/EC of October 27, 2004 o 2002/72/EC of August 6, 2002 o 2002/1/EC of January 6, 2004 o 2004/19/EC of March 1, 2004 o 2005/79/EC of November 18, 2005 o 2007/19/EC of March 31, 2007 o 2008/39/EC of March 6, 2008 o The German Consumer Articles Ordinance of December 23, 1997
• U.S. Pharmacopoeia o <661> Containers o <671> Containers – Permeation (Applies to complete package) o <467> Organic Volatile Impurities o Class VI Biological Reactivity Assay • European Pharmacopoeia 3.1.11. Materials Based on Non-Plasticized Polyvinyl Chloride for Containers for Dry Dosage Forms for Oral Administration • European Pharmacopoeia 3.1.15. Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use • European Pharmacopoeia 3.2.2. Plastic Containers and Closures for Pharmaceutical Use • European REACH (Registration, Evaluation, and Authorization of Chemicals) 1907/2006, REACH Annex XIII, XIV, & XV Substances of Very High Concern (SVHC), and EC No. 465/2008 • The California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) • “Guidance for Industry, Changes to an Approved NDA or ANDA” published by U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) April 2004, CMC, Revision 1