Drug package tests

Extractability tests prescribed by other regulatory agencies [FDA, Parenteral Drug Association (PDA)] for closures for drug packaging [69,70] are also limited to the amount of extractable residues or tests to evaluate the in vivo reaction of the extractable residue when the material fails in the in vitro tests. 

Veillard, M., Bentejac, R., Duchene, D., and Carstensen, J. T. (1979), Moisture transfer tests in blister package testing, Drug Dev. Ind. Pharm. 5,227-244. 

RtiK R and de kruhe n. Active and Intelligent packaging development. Part I. Definitions, efficacy tests and migration experiments. Food, Cosmetics and Drug Packaging 2003, 8, 152-159. 

Containers, closures and other component parts of drug packages, to be suitable for their intended use, must not be reactive, additive or absorptive to the extent that the identity, strength, quality or purity of the drug will be affected. All drug product containers and closures must be approved by stability testing of the product in the final container in which it is marketed. The stability test includes testing filled containers at room temperature (e.g., 70°F) as well as under accelerated conditions (e.g., 105 and 120°F). 

Drug testing Drum agglomerators Drum brakes Drum packages Drums Dry ash... 

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. 

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