Question

Given below are two statements:
Statement I: Rubber stoppers cannot withstand pyrogen-destructive temperatures.
Statement II: In case of rubber stopper for injections reliance must be on an effective sequence of washing, thorough rinsing with WFI, prompt sterilization and protective storage to ensure adequate pyrogen control.
In the light of the above statements, choose the most appropriate answer from the options given below:

• A. Statement I and Statement II are correct
• B. Statement I and Statement II are incorrect
• C. Statement I is correct but Statement II are incorrect
• D. Statement I is incorrect but Statement II are correct

Answer 1

The Correct Option is A

To solve this question, we need to assess the validity of Statement I and Statement II individually and in conjunction.

Statement I: Rubber stoppers cannot withstand pyrogen-destructive temperatures.

Rubber stoppers, commonly used in pharmaceutical preparations, can indeed have limitations when it comes to withstanding high temperature treatments designed to destroy pyrogens (fever-inducing substances). High-temperature sterilization methods, such as dry heat, could potentially degrade rubber stoppers, making them unsuitable. Therefore, Statement I is correct.

Statement II: In case of rubber stopper for injections reliance must be on an effective sequence of washing, thorough rinsing with WFI (Water for Injection), prompt sterilization and protective storage to ensure adequate pyrogen control.

This statement outlines a widely accepted procedure for handling rubber stoppers used in pharmaceutical applications to ensure that they remain free of pyrogens. Washing, rinsing, sterilization, and proper storage are all critical steps in this process. Hence, Statement II is also correct.

Given these analyses, the correct option is: Statement I and Statement II are correct.