Section 25.17. Product containers and their components

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Suitable specifications, test methods, cleaning procedures and, when indicated, sterilization procedures shall be used to assure that containers, closures and other component parts of drug packages are suitable for their intended use. Product containers and their components shall not be reactive, additive or absorptive so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the official or established requirements and shall provide adequate protection against external factors that can cause deterioration or contamination of the drug.

                    
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