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.
Therefore, it is critical to carefully evaluate the primary packaging options available for parenteral products and select a suitable packaging system for the compounded drug product formulation and intended use while ensuring the integrity of the container-closure interface to maintain sterility throughout the product’s shelf-life.
What are the primary packaging systems used for parenteral products, and what are some factors to consider when selecting a packaging system for parenteral products?
There are five primary sterile packaging systems used for parenteral products: vials (glass and plastic), prefilled syringes (glass and plastic), ampoules (glass), cartridges (glass), and bags (plastic).
Factors to consider when selecting a packaging system for parenteral products include the type of product, material compatibility with the product formulation, convenience to the patient or medical administrator, and the integrity of the container-closure interface in maintaining sterility throughout the product’s shelf life.
MediZap’s high-end secondary packaging solutions called Steri-Packs are perfectly set up to work with our E-Beam | X-Ray terminal sterilization process and ensure your parenteral drugs are secure throughout transit to and from our contract sterilization facility.