Blog

PREMIUM QUALITY

PREMIUM QUALITY

Material characteristics
Additional qualities required

  • It must preserve the physical properties of all dosage Forms and protect them against damage or breakage.
  • It must not alter the identity of the product.
  • It must preserve the characteristics properties of the Product to comply specifications.
  • It must protect product against undesirable or Adulterating chemical, biological or physical entities.

Choosing appropriate primary pack Product characteristics/sensitivity

  • Hygroscopicity
  • Physical degradation
  • Chemical degradation
  • Drug release properties
  • Mechanical properties
  • Photosensitivity
  • Gas liberation tendency
  • Dimensional aspects

Choosing appropriate primary pack Selection of packaging material ƒ

  • Moisture barrier requirements ƒ
  • Light barrier requirements ƒ
  • Gas barrier requirements ƒ
  • Chemical properties

Release of chemicals from components of packaging material
Critical parameters during screening

  • Release of visible and /or sub-visible particles ƒ
  • Adsorption or absorption of pharmaceutical components by packaging material ƒ
  • Chemical reaction between pharmaceutical product and packaging material ƒ
  • Degradation of packaging component in contact with pharmaceutical products ƒ
  • Influence of manufacturing process on the container.
  • TESTING AND STABILITY

TESTING AND STABILITY QC

  • Test – routine tests ƒ
  • Vary according to the type of material used ƒ
  • Visual inspection ƒ Identification test ƒ
  • Dimensional test ƒ
  • Physical tests ƒ
  • Chemical tests ƒ
  • Microbiological tests

Leave a Comment

Your email address will not be published. Required fields are marked *