Container and packaging systems

Chapter 3 describes the container closure systems again, this discussion would apply to all dosage forms. It is noteworthy that the regulatory agencies consider containers and packaging systems, all those components that... 

Container and packaging systems utilize various designs and materials of construction (see Table 2-8). Warehoused chemicals can also be stored in loose bulk piles. The overall hazard of a given commodity is derived from the inherent physical properties, fire and explosion hazards and health... 

The United Nations (UN) has developed criteria for the testing of chemical container and packaging systems. This criteria is performance-based and is covered in their publication entitled Recommendations on the Transport of Dangerous Goods. The U.S. Department of Transportation adopted United Nations recommendations in 1990 and amended them in 1996. 

Each Packing Group requires that a container or package meet and be maintained to certain performance criteria for the tests previously mentioned. None of these tests evaluates fire performance of containers and packaging systems and therefore will not provide a complete assessment of all of the hazards associated with warehouse storage. 

Container closure and packaging system information provided... 

Plastic materials are widely used in medical items, such as solution containers, transfusion sets, transfer tubing, devices, and packaging systems. The physiochemical nature of these materials provides medical products with their necessary, desirable performance characteristics. While an important performance characteristic of plastics used in medical application is chemical inertness, interactions between a plastic material and a contacted pharmaceutical product are well documented. Such interactions may include sorption, the uptake of product components by the plastic material, or leaching, i.e., the release of plastic material components into the product. In the case of leaching, both the identities of the leached substances and their accumulation levels may impact the ultimate utility of the product. 

Packaging is an integral part of any medicinal product. Not only from a regulatory point of view, but also the patients . It is only the packaged medicinal product which is stable and suitable for use. The stability of the product follows from the successful combination of formulation, packaging materials and method of production. The correct choice of container and closure system will impact every aspect of product life and usage. This is true for industrial as well as pharmacy (re-) packaged products. 

Aerosols are unique. The various components are all part of the product, and in the aerosol industry, the formulating chemist must be familiar with the entire package assembly and each of its components. AH aerosols consist of product concentrate, propeUant, container, and valve (including an actuator and dip tube). There are many variations of these components, and only when each component is properly selected and assembled does a suitable aerosol product result. A typical aerosol system is shown in Figure 1. 

Filtered valves contain a fine internal filter, typically below the body orifice. This filter prevents clogging by the debris sometimes found in product and package. The use of filtration is recommended with any valve systems containing body, stem, or actuator orifices of 0.25-mm (or smaller) diameter unless exceptional care is taken in the cleaning of product and package components. Valves containing these small orifices are used for products propelled by compressed gas. 

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