Pharmaceutical packaging is obliged to comply with many functions. And it has an influence on the quality, effectiveness and applicability of pharmaceuticals which cannot be underestimated.
Protection, safety, compatibility, and function
This particularly applies for primary packaging, i.e. packaging which comes or can potentially come into direct contact with the dosage form, such as ampoules, ready-to-fill syringes, blister packs, pharmaceutical stoppers or other types of pharmaceutical seals. Therefore, the requirement profile – protection, safety, compatibility and function – needs to be complied with as early as the packaging development phase. This is also regarded as key by the approval authorities who demonstrate the manifold requirements in the European Pharmacopoeia or the United States Pharmacopoeia (USP). Accordingly, proof is required for each new or modified packaging product suitable for designated use of the respective pharmaceutical. A variety of material characteristics require testing, e.g. physical and mechanical properties, processability, resistance to chemicals, cleanliness, hygiene or sterilizability.