2. Introduction Defn :- Art & science of enclosing protecting products for distn, storage, sale & use. Package label- Written, electronic or graphic on packaging or separate but associated label Recognition of product Packaging drug regulations
41. Tamper Resistant Packaging Package having indicator or barrier to entry which if breached or missing provides evidence of tampering. It may involve immediate container/closure system or Sec. container/carton system It was introduced to avoid adulteration of product Eg. Film wrappers, Blister packages, Strip Package, Bubble packs, Shrink Seal, Aerosol container
43. TamperResistant Packaging Film Wrapper End folded wrapper-Cellophane,PVDC, nitrocellulose Fin seal- Crimping Shrink Seal- PE, PP, PVC Blister Package Heat softened sheet of thermoplastic resin & vacuum drawing of sheet in contoured moulds- PVC, PVC/PE, PP, polystyrene, Push through backing- Heat seal coated Al-foil Peelable backing-polyester or paper
44. TamperResistant Packaging Strip Package Formed by feeding 2 webs of heat sealable flexible film thr’ heated crimping roller & product is dropped into pocket formed prior to forming final seal. Cellophane, PE, PVC, etc. Shrink Banding Heat shrinkable polymer slightly larger in diameter than cap and neck ring of bottle Bottle is moved thr’ a heat tunnel which shrinks tubing material tightly to engage cap & neck
45. TamperResistant Packaging Aerosol HC propellant in its cooled liquid phase added to drawn Al-container along with product and spray nozzle contained in gasketted metal ferrule crimmped over opening of container Other Temper Resistant Packagings Bubble pack Breakable caps Sealed Tubes Sealed Cartons
46. Pilferproof Packaging Pilferproof packaging has a closure with greater skirt length which extends below threaded portion to form a bank. It has several narrow metal “bridges” When pilferproof closure is removed bridges break and bank remains in place on the neck of container User can reseal closure but detached band indicates package has been opened Torque required to break bridge is nominal
48. Child Resistant Package To avoid cases of poisoning Reduce risk of accidental ingestion medication Safety cap provided for prescription drug, OTC medicine, pesticide, etc.
50. Glass Material Supercooled liquid of viscosity greater than 1013 poise which is composed of SiO2 (65-75%) tetrahedron modified with oxides of metal cations Monovalent cations- M.P. of glass but also reduce strength eg. Na, K, B Divalent Cations- gives mech. strength and chem. resistance eg. CaO, MgO Trivalent Cations- chem. durability & mech. Strength eg. B2O3, Al2O3
51. Selection of Glass Material Advantages Impermeable Inert Transparent Inexpensive Withstand high temp-pressure Easy to clean No absorption of active Disadvantages Leaching Fragility Flaking Heavy wt. Light trasmission
56. Evaluation of Glass Water Attack Test for Type II glass 3 containers filled 90% of overflow capacity Autoclaving at 121ْC for 30 min 100 ml of combined extract titrated with 0.02N H2SO4 Capacity 100ml or less = 0.7 ml H2SO4 Capacity over 100ml = 0.2 ml H2SO4 High Purity Water
57. Plastic Material Plastics are made of polymer and additives like plasticizer, antioxidant, antistat agent, fillers, lubricant, etc. Additives are not chemically bound hence can migrate into product
58. Selection of Plastic Material Advantages Light Weight, Inexpensive, Nonbreakable Disadvantages Leaching of plastic additives Sorption of API Permeation of water vapours or gas Loss of volatile components Softening of plastic material during autoclaving Chemical reactivity
59. Evaluation of Plastic (USP) Physicochemical Tests Aq. Extract tested for nonvoalatile residue, residue on ignition, heavy metals, buffering capacity Biological Reactivity Tests In vitro Test- Extract placed in contact with mammalian cells to check to toxicity In Vivo Test- Systemic Injection Test- Mice Intracutaneous Inj. Test- Rabbit Implantation Test & Eye Irritaion Test- Rabbit
60. Rubber Material Rubber is generally used as elastomeric closure for vial infusion bottles & cartridges Soft & elastic nature permits needle insertion Resilient- Seal integrity maintained Autoclavable
69. Evaluation of Rubber Physico Chemical Testing Extract of Rubber is prepared and tested for total extractable, heavy metals, pH change, turbidity, reducing agents Biological Testing In Vitro Test: on mammalian cells direect contact test In Vivo Test: Systemic Injection Test- Mice Intracutaneous Inj. Test- Rabbits
70. Evaluation of Rubber Apperance Closures must be free from dust, fibres, pigments, oily pathces, etc. Tackiness Closures washed several times with detergent and autoclaved at 121ْC in dist. Water for 30 min. It should not become tacky
71. Evaluation of Rubber Penetrability Closure fixed to vial and force required to penetrate it measured. It should not exceed in house limits. Self Sealability Half filled vial with methylene blue, then 25 needle punctures made in 5mm circle diameter Vials then inverted in water there should not be leakage of coloured solution
72. Evaluation of Rubber Fragmentation 20 closures selected randomly, 5 times needle penetrated in specific area Needle washed with water to collect fragments Fragments NMT 3 per closure Permeability to water vapours Anhydrous CaCl2 placed in vial, kept it in high humidity conditions, measure wt. gain
73. Metals Metals used as packaging material for creams, aerosols, beverages, etc. Metals can be moulded as collapsible tubes, beverage cans, aerosol containers, etc. The mechanical strength provided by metal containers is advantageous. Leaching of metals into products may cause catalytic oxidation of product Its chemical reactivity may form pharmacologically inert, less active or toxic cpmpounds
75. Metals Gen. Properties Strong(Nonbrekabl) Opaque Mouldable to any shape Withstand high temp-pressure Impermeable to moisture, microbes, gases, light, etc. Disadvantages Leaching (Attcked by acids & alkalis) Sorption Corrosion
76. Applications of Metal Cans, pails, boxes. Closures Aluminium foil, laminate, labels Barrels, kegs, drums Crates Metal bandings
77. Paper and Board Cellulose from gettable fibres (Pulp) Lignin, cerin removed by chemical process Fillers, coloring agents, etc. added Properties Low cost, nontoxic, renewable Strength depends on moisture content Readily printable Poor transperancy & gloss comparative to plastic Can’t be sealed unless coated
