Packaging components

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. 

The polymeric encapsulating resin, modified by additives, must possess adequate mechanical strength, adhesion to package components, manufacturing and environmental chemical resistance, electrical resistance, GTE matching, as weU as thermal and moisture resistance in the use-temperature range. 

Contamination. Manufacturers of cosmetics must be careful to guard against chemical and microbial contamination. Chemical contamination, which may result from the presence of undesirable impurities in raw materials, is avoidable by adhering to rigid specifications for raw materials. Compendial specifications and pubHcations by the CTFA and other professional societies form the basis of most intracompany raw material specifications. Moreover, all packaging components must meet not only physical and design specifications but also such chemical requirements as extractables and absence of dust and similar contaminants (see Packaging, cosLffiTics and pharmaceuticals). 

Does the application or system define materials (i.e., raw materials, packaging components, formulations, etc.) to be used ... 

Does the application or system deal with coding of materials, formulated products or package components (i.e., labels and label identification) ... 

In general, vapor pressures are not all that important in preformulation, but it should always be kept in mind that a substance may have sufficiently high vapor pressure to (a) become lost to a sufficient extent to cause apparent stability problems and content uniformity problems and (b) exhibit a potential for interaction with other compounds and adsorption onto or sorption into package components [27],... 

Several investigators have published research on incompatibilities of preservatives with rubber closures and other packaging components, particularly polymeric materials [11]. Again, challenging the product with selected microorganisms to measure bacteriostatic or bactericidal activity is necessary, including evaluation of efficacy as a function of time throughout the anticipated shelf life of the product. 

The terms quality assurance and quality control are sometimes used interchangeably, but there is an important difference. Quality control generally refers to testing of raw materials, packaging components, and... 

The manufacture and sale of parenteral products is regulated by federal and state laws, as well as by the USP. Federal drug regulations are discussed in detail in Chapter 20. The USP provides specifications, test procedures, standards, etc. for parenteral products and their packaging components. In addition to individual monographs, the USP limits the use of certain additives (see Table 4), limits the size of multiple-dose containers to 30 mL, and requires a suitable preservative to be added to containers intended for multiple use. 

The exact identity of all packaging components, the bulk and filled product, labels, and so on, must be carefully maintained. The production ticket must be written so that it is easily understood and followed by the appropriate production personnel. All procedures should be clearly outlined and limits established for all operators (e.g., heat water to 35 45°C or autoclave sterilize for 15-20 min at 121-124°C). 

Would the packaging components contribute to any biological effects of the medication ... 

An elastomeric closure is a packaging component that is, or may be, in direct contact with a drug product. Elastomer selection for parenteral packaging principally involves consideration of chemical, physical, and biological properties, with emphasis on the stability profile of the drug/container system. Typical elastomeric closure compositions are listed in Tables 1 1. Although certain packaging applications frequently call to mind certain elastomer types, it is not feasible to prescribe specific... 

Current good manufacturing practices (CGMPs) indicate that a parenteral manufacturer should confirm supplier certification on packaging components. The following characteristics are usually monitored for a specific elastomeric formulation ... 

Lined carton systems, bag in box, etc., plus a range of packaging components Labels... 

Present-day instrumental analytical methods lend themselves quite well to the identification, control, and evaluation of packaging materials. There are also precise techniques for measuring the physical and functional characteristics of packaging components. 

Blister packages for pharmaceuticals consist of two basic packaging components lidding material and... 

Containers, Closures, and Packaging Components Production and Process Controfa.-Mother Liquors, In-Process Blending/ Mixing, Validation of Process and Control Procedures, Reprocessing, Process Change, Impurities... 

Packaging components for pharmaceuticals are basically made of glass and polymeric materials such as plastics and rubbers.1 In spite of this simple classification, glass, plastic, and rubber are not elementary materials but rather complex mixtures. 

The evaluation of the chemical stability of a packaging component depends on the likelihood of packaging component-dosage form interaction and is usually... 

The polymeric materials usually used to manufacture rigid closures are practically the same as those seen under plastic containers (Section 6.1.3.2). The same impurities are therefore to be expected in these packaging components. On the other hand, though made of polymeric materials, elastomeric closures present a different structure. In the manufacture of rubber, elastomer, the chief component, is combined with other chemicals to produce a material with specific properties that meet target needs, such as its above-mentioned ability to reseal on repeated use. Table 28 lists the common elastomers used in the pharmaceutical industry and their monomeric structures. 

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