Packaging

Packaging : 

Packaging Gadade Dipak Dilip, Dept. of Pharmaceutics, Bhagwan College of Pharmacy, Aurangabad

Introduction : 

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

Objectives : 

Objectives 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

Primary Packaging : 

Primary Packaging 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

Secondary Packaging : 

Secondary Packaging 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

Tertiary Packaging : 

Tertiary Packaging Used for bulk handling and shipping eg. Barrel, crate, Slip sheet, etc.

Components of Packaging : 

Components of Packaging 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

Components of Packaging : 

Components of Packaging 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

Components of Packaging : 

Components of Packaging Container Closure Carton

Closures : 

Closures 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

Closure liner : 

Closure liner Material inserted in a cap to effect a seal between closure &container usually made of resilient backing & facing material (soft & elastic) Types Homogenous Heterogeneous Selection factors Compatibility Appearance Gas Transmisson Heat resistance Shelf life Economic

USP Terminology : 

USP Terminology 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.

USP Terminology : 

USP Terminology Hermetic Container: Impervious to air or any other gas under ordinary… Light Resistant Containers…

Tamper Resistant Packaging : 

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

Tamper Resistant Packaging : 

Tamper Resistant Packaging Wrapper Strip Aerosol Blister

Tamper Resistant Packaging : 

Tamper Resistant 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

Tamper Resistant Packaging : 

Tamper Resistant 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

Tamper Resistant Packaging : 

Tamper Resistant 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

Pilferproof Packaging : 

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

Pilferproof Packaging : 

Pilferproof Packaging

Child Resistant Package : 

Child Resistant Package To avoid cases of poisoning Reduce risk of accidental ingestion medication Safety cap provided for prescription drug, OTC medicine, pesticide, etc.

Selection of Packaging Material : 

Selection of Packaging Material

Glass Material : 

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

Selection of Glass Material : 

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

Selection of Glass Material : 

Selection of Glass Material Glass Flint glass- Colorless glass Amber colored glass/Nonactinic- Iron & MnO2 Siliconized glass- avoids sticking of oily formulation

Evaluation of Glass : 

Evaluation of Glass Powdered Glass Test (Crushed Glass Test) Digest borosilicate flask 121ْC for 60 min Crush 6 Containers 10gm powder + 50ml high Decant & titrate purity water solution with 0.02N H2SO4 Indicator Methyl red Similarly blank Limits: Type I = 1.0ml, Type III = 8.5ml, NP= 15.0ml Sieving 40/50# 121ْ C 30 min

Evaluation of Glass : 

Evaluation of Glass Water Attack Test for Type II glass 3 containers filled 90% of overflow capacity 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 High Purity Water

Plastic Material : 

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

Selection of Plastic Material : 

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

Evaluation of Plastic (USP) : 

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

Rubber Material : 

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

Rubber Material : 

Rubber Material 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

Selection of Rubber Material : 

Selection of Rubber Material 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

Selection of Rubber Material : 

Selection of Rubber Material Advantages Softness allows needle insertion Resilence maintains sterility Elasticity allows perfect fit Disadvantages Permeation Leaching Sorption Loss of volatile component

Evaluation of Rubber : 

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

Evaluation of Rubber : 

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

Evaluation of Rubber : 

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

Evaluation of Rubber : 

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

Metals : 

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

Metals : 

Metals

Metals : 

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

Applications of Metal : 

Applications of Metal Cans, pails, boxes. Closures Aluminium foil, laminate, labels Barrels, kegs, drums Crates Metal bandings

Paper and Board : 

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

Slide 44: 

Thank You…