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Which of the following is not a requirement for the packaging of sterile injectable products? A. Single dose products must be packaged in vials or ampules that contain less than 30 ml. B. A single dose container must be hermetic but once it has been opened it cannot be resealed with assurance that sterility has been maintained. C. A multi-dose container must be hermetic, but due to the packaging, the sterility of the contents is maintained to allow withdrawal of successive doses. D. The material of the container and its closure must not interact with the drug preparation in a way that alters the strength or efficacy of the product.

Question

Which of the following is not a requirement for the packaging of sterile injectable products? A. Single dose products must be packaged in vials or ampules that contain less than 30 ml. B. A single dose container must be hermetic but once it has been opened it cannot be resealed with assurance that sterility has been maintained. C. A multi-dose container must be hermetic, but due to the packaging, the sterility of the contents is maintained to allow withdrawal of successive doses. D. The material of the container and its closure must not interact with the drug preparation in a way that alters the strength or efficacy of the product.

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Solution

The statement that is not a requirement for the packaging of sterile injectable products is A. "Single dose products must be packaged in vials or ampules that contain less than 30 ml." There is no specific volume limit for single dose products. The key requirement is that they should not contain more than one dose, regardless of the volume. The other statements B, C, and D are all true and are important requirements for the packaging of sterile injectable products.

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Packaging only protects the product during transport.Group of answer choicesTrueFalse

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