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Sterile Reconstitution

Meaning

Sterile reconstitution is the clinical procedure of adding a sterile diluent, such as bacteriostatic water, to a lyophilized, or freeze-dried, pharmaceutical powder in a strictly aseptic environment to prepare an injectable solution. This process is mandatory for many peptide and protein-based biologics which are inherently unstable in liquid form and must be stored as a powder to maintain potency. The technique requires meticulous attention to aseptic technique to prevent microbial contamination and to ensure the final solution is free of particulate matter, thereby guaranteeing the safety and efficacy of the administered medication. Proper sterile reconstitution is a non-negotiable step in the clinical use of many hormonal agents.