Packaging selection is critical when developing compounded sterile parenteral products. The primary packaging system must be compatible with the product formulation, maintain sterility, and be convenient for use by patients or medical administrators.

Packaging selection for parenteral products must also consider the product’s intended use. For example, single-dose injectables may require primary packaging with smaller volumes to prevent wastage, while multi-dose products may require larger volume primary packaging to accommodate multiple doses.

In addition to compatibility and convenience, the packaging system must have appropriate seal strength and integrity to protect against microbial contamination. Every compounder is required to have completed container closure testing under USP standards to prove sterile seal performance. This is especially important for sterile drug products, as microbial contamination can compromise the efficacy and safety of the product, leading to potential health risks for patients. Read More >