Primary packaging

Polyethylene shrink film wrapping of cormgated ftberboard trays is in common use outside of the United States. Equipment erects the trays, fills the trays with primary packages such as cans or jars, wraps the grouping in shrink film, and heat shrinks the combination. Shrink film wrapping keeps primary and secondary packaging materials clean and dry. 

Group 3 Nitrate/metal compositions without sulphur Compositions with <35-65% chlorate Compositions with black powder Lead oxide/silicon with >60% lead oxides Perchlorate/metal Burn fast Large firework shells Fuse protected signal flares Pressed report cartridges in primary packagings Quickmatches in transport packagings Waterfalls Silver wheels Volcanoes Black powder delays Burn very violently with single-item explosions... 

Identify marking requirements for product, as well as secondary and primary packaging. 

Since full analyses are carried out, a lot of data are generated. Every parameter is reviewed for trends that signal product aging or outright decomposition of the active principle this can be as cosmetic in nature as discoloration or as potentially hazardous as buildup of toxic derivatives. If the drug substance is an ester, for example, hydrolysis, particularly if moisture penetrates the primary packaging material, will decompose the compound into its acid and alcohol components. From a pharmaceutical or medical viewpoint, even if there is no toxicity issue involved, this will result in a loss of bioavailability. Even this is to be avoided because subpotency introduces therapeutic uncertainty and can go as far as lethal undertreatment. 

Small fireworks in primary packagings Signal ammunition in transport packaging Delays without black powder... 

Loss of the native conformation of a protein generally exposes hydrophobic amino acid residues that are normally buried on the inside of the self-associated structure and are shielded from the aqueous environment. This leads to association between the exposed hydrophobic residues of neighboring proteins (aggregation) or between these exposed residues and hydrophobic surfaces that the protein may encounter either in the manufacturing process or in the primary package. 

The choice of the primary packaging should be justified. This should include consideration of the safety of the packaging for the patient and user. Account should be taken of the optimal sterilization method for the finished product. 

In addition to the various advice included in the development pharmaceutics guidelines there is also a specific guideline on plastic primary packaging materials (3AQ10a, adopted February 1994), which describes general requirements for all plastic containers but pays particular attention to those for parenteral and ophthalmic use. 

Cleaning of primary packaging material is normally considered to be a GMP issue, although data may be requested. Sterilization processes applied to packaging materials need to be described in the application in the normal manner. 

AQ10a Plastic primary packaging materials (pages 75-82)... 

Pharmaceutical containers and packages, primary packaging of pharmaceuticals. .. 

Medical, laboratory and care applications transparent pre-filled syringes, pharmaceutical containers and packages, primary packaging of pharmaceuticals, medical devices, diagnostic disposables, laboratory ware. .. 

The packaging of a medicinal product fulfils a variety of roles such as product presentation, identification, convenience and protection until administration or use. Selection of packaging requires a basic knowledge of packaging materials, the environmental conditions to which the product will be exposed and the characteristics of the formulation. Several types of packaging will be employed, the primary packaging around the... 

These are areas where primary packaged products are handled (e.g. visual inspection of ampules, vials, blisters, and final packaging operations). Depending on the product mix manufactured, the control of temperature and relative humidity may be necessary. 

These are areas where personnel could come into direct contact with open materials (starting materials, intermediate product, bulk product, and open primary packaging materials), for example, all operations (sampling, compounding, and producing) for manufacturing of solids, semisolids, and liquids for oral and topical use. 

Ulmschneider, M., and Pdnigault, E. (2000b), Direct identification of key-intermediates in containers using Fourier-Transform near-infrared spectroscopy through the protective polyethylene primary packaging, Analusis, 28,136-140. 

Container Closure System — The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system. 

When information on a container closure system is submitted in an application, the emphasis would normally be on the primary packaging components. For a secondary packaging component, a brief description will usually suffice unless the component is intended to provide some additional measure of protection to the drug product. In this case, more complete information should be provided, along with data showing that the secondary packaging component actually provides the additional protection. 

Identification of the materials of construction (i.e., plastics, paper, metal, glass, elastomers, coatings, adhesives, and other such materials) should be identified by a specific product designation (code name and/or code number) and the source (name of the manufacturer) alternate materials of construction should be indicated postconsumer recycled plastic should not be used in the manufacture of a primary packaging component, and if it is used for a secondary or associated component, then the safety and compatibility of the material for its intended use should be addressed appropriately... 

A typical container closure system is a plastic (usually HDPE) bottle with a screw-on or snap-off closure and a flexible packaging system, such as a pouch or a blister package. A typical closure consists of a cap — often with a liner — frequently with an inner seal. If used, fillers, desiccants, and other absorbent materials are considered primary packaging components. 

For some types of product we may also need to consider the primary packaging. Very often, it can be as important to understand the limitations of these three components as it is to understand their properties or advantages. Beyond these three... 

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