Primary packaging testing

From routine pharmacopeial testing to extractables and leachables studies, RSSL can provide a full suite of analytical testing services for primary packaging.

 

 

Vital analysis

 

As it has direct contact with the drug product, testing of primary packaging is vital. In addition to ensuring the packaging material is suitable for end-use throughout the lifetime of the product, analysis of primary packaging is also an important regulatory requirement. 

 

 

Full suite of testing

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RSSL provides a full suite of primary packaging testing services. We can conduct routine pharmacopeial tests on packaging systems (syringes, vials, stoppers, glass etc.), including physical tests of packaging components for optimisation of quality and performance. On top of this we also offer container closure integrity testing to certify containment and protect the dosage form.   

Additionally, we can establish generic characteristics of your primary packaging, such as identity and composition, biocompatibility and general physicochemical properties. We can undertake extensive extractables and leachables studies to ensure that no chemicals transfer from the packaging into the drug.

Our analytical services for primary packaging testing include:

 

  • Thermal analysis (via differential scanning calorimetry (DSC), for example melting point, glass transitions, specific heat capacity) 
  • Internal structural analysis (X-Ray tomography)   
  • Density 
  • Physical tests, including CCIT extending for the full life cycle of the packaging 
  • Nominal volume, stopper type 
  • X-Ray fluorescence 
  • Visual inspection 
  • Scanning electron microscopy coupled with X-ray microanalysis 
  • Spectroscopic methods (confocal Raman microscopy, FT-IR, micro-FT-IR)  

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