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
- Physical degradation
- Chemical degradation
- Drug release properties
- Mechanical properties
- Gas liberation tendency
- Dimensional aspects
Choosing appropriate primary pack Selection of packaging material
- Moisture barrier requirements
- Light barrier requirements
- Gas barrier requirements
- Chemical properties
Release of chemicals from components of packaging material
Critical parameters during screening
- Release of visible and /or sub-visible particles
- Adsorption or absorption of pharmaceutical components by packaging material
- Chemical reaction between pharmaceutical product and packaging material
- Degradation of packaging component in contact with pharmaceutical products
- Influence of manufacturing process on the container.
- TESTING AND STABILITY
TESTING AND STABILITY QC
- Test – routine tests
- Vary according to the type of material used
- Visual inspection Identification test
- Dimensional test
- Physical tests
- Chemical tests
- Microbiological tests