Module 3 Presentations

07/05/2024

What does “packaging” mean?

Immediate packaging / Primary packaging / Container

• The container or other form of packaging immediately in contact with the medicinal product (Directive 2001/83/EC amended) • A container for pharmaceutical use is an article which contains or is intended to contain a product and is, or may be, in direct contact with it. The closure is a part of the container. (Ph. Eur. – 3.2) • Materials used in pharmaceutical packaging which will contain, seal or be used for dose application of a medicinal product and which will have direct contact with the medicinal product (ISO 15378) • The packaging into which is placed the immediate packaging (Directive 2001/83/EC amended) • non-contact packaging materials, which include printed or unprinted cartons, labels, leaflets or inserts (or outserts), over-wraps, and transit containers such as folding boxes (ISO 15378) Outer packaging / Secondary packaging

The Organisation for Professionals in Regulatory Affairs

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What does “packaging” mean?

Usual packaging materials for pharmaceutical primary packaging Glass • Tubular glass (e.g. syringes, cartridges, injection vials, (small) bottles, ampoules) • Molded glass (e.g. infusion bottles) Polymers (Elastomers, Plastics) • Elastomers (e.g. rubber stopper, tip caps) • Thermoplastic Elastomers (e.g. tip caps) • Thermoplastics (e.g. foils, molded parts, blow-molded parts) Metals • Aluminum (e.g. Foils, Tubes)

The Organisation for Professionals in Regulatory Affairs

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