BY PACKAGING


Non-Sterile Product: Quality Control

  1. Water vapour permeability – the water vapour permeability of the pack containing the product is required. This is necessary because although the bottles will comply with the water vapour permeability test described in USP, permeation through the bottle wall will depend on whether the product has a high or low affinity for the water. The test split into two parts to enable the maximum amount of information to be obtained and hence possibly eliminating the necessity to perform further time consuming experiments.
  2. Light transmission – this test is to determine the effect of light passing through the bottle wall on the product stability and appearance. The bottle wall thickness can have a significant effect on the results obtained.
  3. Product stability – it is unlikely that a compatibility problem, particularly with the film coated tablet, will occur, although it is necessary to check up full life of the product.