Primary, Secondary and Tertiary Packaging

Product & Process Division

Validation for the packaging

Pharmaceutical Primary, Secondary and Tertiary Packaging are the final keeper of the pharmaceutical drug formulation and represent the physical barrier between the external environment and the final patient. It is fundamental, therefore, to qualify the performance and the features of the material constituent of the containers from the early stages of their developments up to the final verification at the end of product shelf life.

Related to this crucial operation, DOC can support you with:

  • Compatibility Study
  • Adsorption Study
  • Extractables and Leachables Studies on Elastomeric closures, Glass and Plastics:
    • Qualification and Quantification of Non-Volatile, Semi-Volatile and Volatile compounds applying several analytical techniques (refer to Equipment and Instrumentation List) for:
      • Additives
      • Inorganics
      • Organics
      • Metals and Heavy Metals
      • Monomers and Residues
    • Contaminants (Investigation)
    • LOD and LOQ values determination
    • Inner surface durability of Glass Containers (according to USP <1660> requirements)
      • Degree of pitting
      • Metal Ions
      • Conductivity/pH
      • Presence of lamellae
      • Sub-visible glass particles
    • Stability Studies
    • Toxicological Evaluation
    • Integrity Container Closure Test

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