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Sterility Risks

Meaning

Sterility risks, in the clinical and pharmaceutical context, denote the potential for a therapeutic compound or medical device to be contaminated with viable microorganisms, including bacteria, fungi, or spores, which could lead to severe systemic infection upon administration. For injectable hormonal preparations, such as peptides or bioidentical hormones, maintaining absolute sterility is a non-negotiable quality standard to ensure patient safety and prevent iatrogenic harm. A breach of sterility constitutes a critical failure in quality assurance.