PF 51[6] Ophthalmic Products—Quality Tests
antimicrobial preservatives Multidose drug products shall contain a suitable antimicrobial preservative, and the effectiveness of the preservative during the use period of the drug product must be verified. The efficacy of the preservative must also be maintained for the shelf life of the product. Alternatively, preservative-free multidose drug products require a packaging system that has been demonstrated to maintain sterility during the use period of the drug product. The efficacy of the preservative-free packaging system must also be maintained for the shelf life of the drug product. Antimicrobial agents must be added to products that are packaged in containers that allow for the withdrawal or administration of multiple doses, unless one of the following conditions prevails: 1) there are different directions in the individual monograph; 2) the radiopharmaceutical drug product contains a radionuclide with a physical half-life of <24 h; 3) the drug product, without additional agents, is sufficiently microbicidal to meet the requirements of Antimicrobial Effectiveness Testing <51>; or 4) the container–closure system is capable of maintaining sterility of the product throughout its shelf life until opened or accessed. Once opened or accessed, it must maintain antimicrobial effectiveness during the intended use period. Antimicrobial agents must meet the requirements of <51>> and Antimicrobial Agents — Content <341>. Acceptance criteria for antimicrobial preservative content in multidose products should be established. [from PF 51[6] <771> Ophthalmic Products—Quality Tests]
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M20
10,12,15,20
4
40
