A non-sterile nasal spray production process is presented and examined with the aim of eliminating the gamma terminal sterilization step. Several key points, including but not limited to process design, bioburden control, and environmental monitoring (EM) are considered alongside this endeavor. By implementing the best practices dependent on these factors, sterile filtration prior to filling can be achieved.
Bioburden contamination control is critical to pharmaceutical product manufacturing, both sterile and non-sterile. Nasal sprays are considered non-sterile products, meaning the final product bioburden level (microbial contamination index) cannot be completely eliminated, but must be controlled to appropriate levels. It is fundamental for a successful and reliable manufacturing process to embrace a risk-based approach to contamination control, as outlined in USP 1115 Bioburden control of non-sterile drug substances and products.
This approach leads to a well-structured internal SOP and quality system.
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