Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents.
Secondary packaging is outside the primary packaging - usually used to group primary packages together.
Tertiary packaging is used for bulk handling warehouse storage and transport shipping. The normal form is a unit load that packs tightly into containers.
These broad categories are arbitrary in nature. For example, depending on the use, a shrink wrap can be primary packaging when applied directly to the product, secondary packaging when combining smaller packages, and tertiary packaging on some distribution packs. A transport package or distribution package is the package form used to ship store and handle the product or inner packages.
A container for pharmaceutical use is an article which holds or is intended to contain and protect a drug and is or may be in direct contact with it. The closure is a part of the container. The container and its closure must not interact physically or chemically with the substance within in any way that would alter its quality. The following are general terms used to describe pharmaceutical containers for packaging.
- Well-closed containers must protect the contents from extraneous matter or from loss of the substance under normal conditions of handling, shipment or storage.
- Tightly closed containers must protect the contents from extraneous matter, from loss of the substance, and from efflorescence, deliquescence or evaporation under normal conditions of handling, shipment or storage. If the container is intended to be opened on several occasions, it must be designed to be airtight after reclosure.
- Hermetically closed containers must protect the contents from extraneous matter and from loss of the substance, and be impervious to air or any other gas under normal conditions of handling, shipment or storage.
Substances and dosage forms requiring protection from light should be maintained in a light-resistant container that – either by reason of the inherent properties of the material which it is composed, or because a special coating has been applied to it – shields the contents from the effects of light. Alternatively, the container may be placed inside a suitable light-resistant (opaque) covering and/or stored in a dark place.