Parenteral packaging

Increasingly, plastics are being used as parenteral packaging (qv) materials. Plastics such as poly(vinyl chloride), polyethylene, and polypropylene are employed. However, plastics may contain various additives that could leach into the product, such as plasticizers (qv) and antioxidants. PermeabiUty of plastics to oxygen, carbon dioxide, and water vapor must be tested in the selection of plastic containers. Furthermore, the plastic should withstand sterilization. Flaking of plastic particles should not occur and clarity necessary for inspection should be present. 

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... 

Table 2 Common elastomers used in parenteral packaging components...

Rubber components are now used extensively for many parenteral packaging and administration applications including injection vials and prefilled syringes. Because of its varied chemical nature and risk of extractables, rubber is regarded by many as the most critical of the primary packaging materials, especially as a wide range of constituents can be involved (see below). 

Siliconization comprises the surface treatment of the parenteral packaging component with silicone. The use of silicones in pharmaceuticals dates back to 1950 when it was first used to coat the glass vial interior [7]. Later on, the use of silicone was extended to glass syringes, rubber stoppers, hypodermic needles, etc. 

Various types of medical grade silicones for parenteral packaging are available from different companies. The ones from... 

A. Colas, J. Siang, and K. Ulman, Silicones in Pharmaceutical Applications. Part 5 Siliconization of Parenteral Packaging Components, Dow Corning, Inc., 2006. 

The diversity of radionucHde half-life and chemical nature of commonly used radiopharmaceuticals demands a variety of formulation matrices, packaging containers, and storage conditions. The containers, ingredients, and processes used in these products must meet the stringent requirements for parenteral pharmaceuticals, as well as provide safe conditions for storage, handling, and disposal of the radioactive material. 

Some parenteral dragp are available as a crystal or a powder. Because these dru have a short life in liquid form, they are available in ampules or vials in dry form and must be made a liquid (reconstituted) before they are removed and administered. Some of these products have directions for reconstitution on the label or on the enclosed package insert. The manufacturer may give... 

PARENTERAL ADMINISTRATION. The nurse should read the manufacturer s package insert for each drug for instructions regarding reconstitution of powder for injection, storage of unused portions, life of the drug after it is reconstituted, methods of IV administration, and precautions to be taken when the drug is administered. 

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. 

M. J. Akers, in Parenteral Quality Control Sterility, Pyrogen, Particulate, and Package Integrity Testing, Vol. 1 (J. R. Robinson, ed.), Marcel Dekker, New York, 1985, pp. 207-209. 

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 ... 

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. 

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