05/09/2024
Secondary packaging components are identified by the FDA as serving one or more of the following functions:
provide protection from excessive transmission of moisture or solvents into or out of the packaging system.
provide protection from excessive transmission of reactive gases (atmospheric oxygen, inert headspace filler as, or other organic vapors) into or out of the packaging system.
provide light protection for the packaging system.
provide protection for a packaging system that is flexible or needs extra protection from rough handling.
provide an additional measure of microbiological protection (e.g., by maintain sterility or by protecting the packaging system from microbial intrusion)
Since secondary packaging components are not intended to make contact with the dosage form of the product, they are regulated somewhat differently than primary container closure components. In a new drug application, emphasis is typically placed on the primary components. If the secondary packaging component is specifically intended to provide extra safety measures to the product, such as safety device attached to a syringe, complete information about the packaging material should be provided, including proof that packaging material is quite permeable, such as low density polyethylene (LDPE), the packaging could be considered a potential source of contamination. Permeable packaging materials, in some cases, can facilitate migration of ink or adhesive materials, which can harm the product