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  1. 1.  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
  2. 2.  Physical protection eg. Shock, vibration Barrier protection eg. O2, light Containment eg. 10*10 packs Information trasmission eg. Direction Marketing potential Security eg. Antithept seal, Convenience eg. Distribution, handling, sale Portion control eg. Single dosage pack
  3. 3.  Packaging material that is in intimate contact with product First envelopes & holds product Smallest unit of distribution eg. Aerosol can, wrappers, bottle, envelope It should be inert (no leaching, absorption or adsorption, etc.) Should withstand mfg. condition eg. Freezing
  4. 4.  Packaging material outside the primary packaging Perhaps used to group primary packaging eg. Boxes, cartons, shrink-wrap, etc. Should protect from excessive moisture, light, reactive gases, microbes, etc. Protection to flexible container Ease in handling
  5. 5.  Used for bulk handling and shipping eg. Barrel, crate, Slip sheet, etc.
  6. 6.  Container: refers to storage media in which product is placed or enclosed. Glass, Plastic Closure: tightly packs container to exclude O2, CO2, moisture and micro-organisms & prevent loss of water and volatile substances from product. Rubber, aluminum
  7. 7.  Carton: Outer covering which gives sec. protection against mech. & environmental hazards also display written information Cardboard, molded wood pulp, expanded polystyrene Box: Prim. defence against ext. hazards provide containment, absorbs shocks. Cardboard, wood
  8. 8. Container Closure Carton
  9. 9.  Prevents contents from escaping and allow no substance to enter the container Resiliency of liner, flatness of sealing surface & tightness of seal Closure designs:  Threaded screw cap- Engage threads in corresponding threads molded on neck of bottle  Crimp on (crown)- Used for beverage bottles  Press on(snap)- Cap pressed to seal  Roll on- Seals securely, opened easily, specific, available as reselable, nonresealable & pliferproof  Friction design
  10. 10.  Material inserted  Selection factors in a cap to effect  Compatibility a seal between  Appearance closure &container  Gas Transmission usually made of  Heat resistance resilient backing &  Shelf life facing material  Economic (soft & elastic) Types  Homogenous  Heterogeneous
  11. 11.  Well closed Container: Protects from extraneous solids & loss of article under ordinary or customary conditions of handling, shipment, storage & distribution Tight Container: Protects from contamination by extraneous material, prevents loss of by vaporization, efflorescence, deliquescence under ordinary or customary conditions of handling, shipment, storage & distribution and capable of tight re-closure.
  12. 12.  Hermetic Container: Impervious to air or any other gas under ordinary… Light Resistant Containers…
  13. 13.  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
  14. 14.  Wrapper Strip Aerosol Blister
  15. 15.  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
  16. 16.  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
  17. 17.  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
  18. 18.  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
  19. 19.  To avoid cases of poisoning Reduce risk of accidental ingestion medication Safety cap provided for prescription drug, OTC medicine, pesticide, etc.
  20. 20.  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
  21. 21.  Advantages  Disadvantages  Impermeable  Leaching  Inert  Fragility  Transparent  Flaking  Inexpensive  Heavy wt.  Withstand high  Light trasmission temp-pressure  Easy to clean  No absorption of active
  22. 22.  GlassType Description UseI Highly resistant For aqueous solution borosilicate (neutral glass)II Surface treated soda lime For Aq. Soln, dry glass powders, oily solutionsIII Sodalime glass For dry powders, oily (Regular) solutionsIV Nonparenteral glass (NP) NP use Flint glass- Colorless glass Amber colored glass/Nonactinic- Iron & MnO2 Siliconized glass- avoids sticking of oily formulation
  23. 23.  Powdered Glass Test (Crushed Glass Test) Digest borosilicate flask 121C for 60 min Crush 6 Containers Sieving 10gm powder 40/50# + 50ml high 121 C Decant & titrate 30 min purity water solution with 0.02N H2SO4 Indicator Methyl red Similarly blank Limits:  Type I = 1.0ml, Type III = 8.5ml, NP= 15.0ml
  24. 24.  Water Attack Test for Type II glass 3 containers filled 90% of overflow capacity High Purity Water Autoclaving at 121 C 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
  25. 25.  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 Material Use PE, PP IV infusion container HDPE, PP, PS Disposible syringes Polypropylene IPP) Dialysis fluid & irrigation solution container
  26. 26.  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
  27. 27.  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
  28. 28.  Rubber is generally used as elastomeric closure for vial infusion bottles & cartridges Soft & elastic nature permits needle insertion Resilient- Seal integrity maintained Autoclavable
  29. 29.  Composed of  Polymer (elastomer)-  Vulcanising Agent- cross linking eg.sulphur  Accelerator- reduce sulphur requirement & time for vulcanization eg. MBT  Activator- Activity of accelerator  Filler- carbon black, talc  Antioxidant- Prevents oxidatn of elastomer  Lubricant- Mould release eg.Talc  Softner- Plasticity eg. Mineral oil
  30. 30.  Types of Rubber  Natural- Haevea brazilensis high preservative uptake  Grey butyl-Polyisobutyl-Low permeability & low preservative uptake  Nitrile- Butadiene acrylonitrile Oil resistant  Silicone Rubber- Heat resistant & high uptake
  31. 31.  Advantages  Disadvantages  Softness allows  Permeation needle insertion  Leaching  Resilence maintains  Sorption sterility  Loss of volatile  Elasticity allows component perfect fit
  32. 32.  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
  33. 33.  Apperance  Closures must be free from dust, fibres, pigments, oily pathces, etc. Tackiness  Closures washed several times with detergent and autoclaved at 121C in dist. Water for 30 min. It should not become tacky
  34. 34.  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
  35. 35.  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
  36. 36.  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
  37. 37. Material UseTin Foods, pharmaceuticals, AerosolAluminium Collapsible tubes, foil packing, AerosolLead Non food products like inks paints, lubricantsStainless Aerosol containerssteel
  38. 38.  Gen. Properties  Disadvantages  Strong(Nonbrekabl)  Leaching (Attcked  Opaque by acids & alkalis)  Mouldable to any  Sorption shape  Corrosion  Withstand high temp-pressure  Impermeable to moisture, microbes, gases, light, etc.
  39. 39.  Cans, pails, boxes. Closures Aluminium foil, laminate, labels Barrels, kegs, drums Crates Metal bandings
  40. 40.  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