The production procedure of parenteral products involves several meticulously controlled steps to ensure safety, efficacy, and sterility:
Formulation Development: Based on preformulation studies, determining the appropriate vehicle, additives, and concentrations.
Weighing and Mixing: Precise measurement of active pharmaceutical ingredients (APIs) and excipients, followed by thorough mixing to ensure homogeneity.
Sterilization: Methods include:
Heat Sterilization: Autoclaving, suitable for heat-stable products.
Filtration: Using membrane filters (0.22 µm) for heat-sensitive solutions.
Filling: Transferring the sterile solution into containers (vials, ampoules) under aseptic conditions.
Sealing: Ensuring containers are securely sealed to maintain sterility and prevent contamination.
Lyophilization (if applicable): Freeze-drying the product to enhance stability, followed by sealing in a dry environment.
Packaging: Final packaging with appropriate labeling and protection from environmental factors.
Quality Control: Rigorous testing at each stage to ensure compliance with specifications.