Packaging – are economical means of providing Packaging Materials
presentation, protection, identification/information, 1. Blass – available in white, flint/amber
containment, convenience, and compliance for a colored product during storage, carriage, display and use until Types such time as the product is used or administered I – highly resistant borosilicate glass II – treated Soda-lime glass Types III – Soda lime glass a) Primary packaging – directly contains the product IV / NP – general purpose soda-lime glass b) Secondary packaging – external to the primary packaging 2. Plastics a) Polyethylene Container – holds the drug product and is or may be b) PVC (unplasticized, plasticized) in direct contact with the drug product c) Polypropylene (homopolymer, copopolymer) Types of Containers: d) Polystyrene (general purpose, impact a) Well-closed container modified) b) Tight container c) Hermetic container 3. Metal: Tin, Aluminum, Aluminum alloy d) Single-unit container e) Multiple-unit container 4. Paper and Board – labels, cartons, layer f) Child-resistant container boards g) Light-resistant container h) Tamper-evident packaging 5. Films, Foils, and Laminates – sachets, seals, strips, blisters Storage Conditions Term Condition 6. Rubber: closure for sterile products 1. Cold Not exceeding 8˚C Freezer -25˚C - 10˚C Refrigerator 2˚C - 8˚C 2. Cool 8˚C - 15˚C 3. Controlled Cold 2˚C to 8˚C but allows excursions temp. between 0˚C to 15˚C 4. Room temp. 20˚C - 25˚C 5. Controlled 20˚C to 25˚C but allows Room temp. excursions between 15˚C to 30˚C 6. Warm 30˚C - 40˚C 7. Excessive heat Above 40˚C 8. Dry place Does not exceed 40˚C