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See all Premium member Presentation Transcript PACKAGING OF PHARMACEUTICAL PRODUCT : PACKAGING OF PHARMACEUTICAL PRODUCT K.Senthil kumar Asst.prof QIS College of Pharmacy .INTRODUCTION : INTRODUCTION Pharmaceutical container is defined as a device that hold the pharmaceutical formulation and it may or may not be in direct contact with container . Closure is defined as device which is intended for opened and closed container.Criteria for containers : Criteria for containers It must be neutral It must not react physically or chemically with the substance . It must maintain the stability by resist the environmental factors It must designed simply for withdraw a dose . It must withstand change in pressure during the sterilization . Closure of the container must be easily removable and replaceable.Disadvantage of container : Disadvantage of container They are permeable to water vapour and atmospheric gas They cannot withstand heat They may absorb chemical substanceTypes of containers : Types of containers Well close container It protect the content from contamination with unwanted foreign particle and loses during use .Slide 6: Hermeticaly sealed container : These container protect the product from dust , moisture and air .Slide 7: Tight ly closed container : These container protect the content from the loss due to deliquescence or evoapration of the product.Slide 8: Light resistant container : The se container protect the medicament from harmful effect of light.Slide 9: Tamper evident container : The content cannot be used without any destruction of the seal.Slide 10: Single dose container : These container are used to supply only one dose of medicament Multiple dose container : These containers allow the with drawl of dose at various interval without changing the quality.PARENTERALS CONTAINERS : PARENTERALS CONTAINERSSlide 12: Types of primary and secondary packaging material Material Type Example of use Glass Primary Metric medical bottle, ampoule, vial Plastic Primary Ampoule, vial, infusion fluid container, dropper bottle Secondary Wrapper to contain primary pack Cardboard Secondary Box to contain primary pack Paper Secondary Labels, patient information leafletTYPES OF PACKAGING : TYPES OF PACKAGING Primary packaging Secondary packaging Accessories Glass bottle and jars Cartons ( papernoard boxes ) Leaflets ,labels Strip packs Prescription dispensing container Shrink wrap and bands Plastic bottle Corrugated boxes Wrappers Blister packs Paper drums Inner seals Pouches Shipping containers Gum tapes Ointment tube Injection trays Shrinkwraps Vials and ampoules Paper,foil, IV containers Rubber stopper Pre filled syringes Aerosol containers Pre filled inhalers Aerosol inhalers Paperboad containersSlide 14: COMPONENTS OF PACKAGING Glass Metals Rubbers Plastics Foil, films &laminatesSlide 15: Glass container very commonly used in pharmaceutical packaging because Advantage: They are transparent They are available in various shape and size They can withstand the variation in temperature and pressure Less cost They can protect the medicament from light They are impermeable to moisture and atmosphere gas GLASS CONTAINERSSlide 16: Disadvantages : Easy breakable Glass container is heavy weight They may release the alkali to aqueous preparation .COMPOSITION OF GLASS: COMPOSITION OF GLASS Glass is composed of sand , soda ash , lime stone and cullet ( waste glass) and silicone , al, boron , potassium calcium ,zinc are used in the preparation of glass.Types of glass : Types of glass Type I : ( Borosilicate glass ) It is highly resistant type. It consist of mainly silicondioxide and boric oxide etc….. It is suitable for parenteral products Type II (Treated soda lime glass) It is obtained by treating with sulphurdioxide or ammonium sulphate or ammonium chloride . It is suitable for parenteral productsSlide 19: Type III ( Sodalime glass ) It is suitable for anhydrous parenteral product Type IV ( NP): It is suitable for oral and topical product packing .PLASTICS : PLASTICS Plastics are synthetic polymers of high molecular weight . plastic is made from one or more polymer with additives . Eg. Polyethylene (PE) Polypropylene (PP) Polyvinyl chloride (PVC) Polystyrene (PS) Polymethyl metha acrylate (PMMA) Polyethylene terephthalate (PETP) Polytrifluroethylene (PTFE) Polyamide (Nylon ) PolycarbonateAdditives : Additives Antioxidant Antisiatic agent (reduce the surface electrical chrages)- PEG esters Colours Lubricant Plasticizer StabilizersAdvantage of Plastics : Advantage of Plastics Low in cost Light weight Pleasant to touch Unbreakable Leaker proof Odorless and inertClassification of Plastics : Classification of Plastics 1.Thermoplastic type Thermoplastic are softened to a viscous fluid while heating and hardens again on cooling. Eg. Nylon ,PS , PMMA . 2. Thermosetting type These plastic may become flexible but doesnot become fluid on heating . They are generally hard and brittle at room temperature. Eg. Phenol formaldehyde resin , urea formaldehyde resin.STERILIZATION OF PLASTICS: STERILIZATION OF PLASTICS Method of Sterilization Sterilization condition Plastic Moist heat 121 0 c for 15 mts HDPE, PP, PC PMP , ETEF,Teflon ,FEP, PFA , PVC Dry heat 160 -180 o c for 1-3 h ECTFE, ETFE , Teflon , FEP , PFA Gaseous sterilization Ethylene oxide with negative pressure or inert gas HDPE, PP, PC PMP , ETEF,Teflon ,FEP, PFA , PVC Gamma irradiation High molecular weight , low density material are more resistant to radiation. Chemical disinfectant Formalin / QAC / BAC Generally suitable for all plasticWELL CLOSED PLASTIC CONTAINER: WELL CLOSED PLASTIC CONTAINERPLASTIC CONTAINERS: PLASTIC CONTAINERSSlide 28: Pre filled syringes Eye / ear drops container Plastic traysOINTMENT JAR FOR OINTMENTS: OINTMENT JAR FOR OINTMENTS PLASTIC CONTAINERS : PLASTIC CONTAINERS Tablets for plastic bottle Tablets for fluted bottleIV PLASTIC BAGS : IV PLASTIC BAGSMETAL: METAL Advantages: Metal containers are strong Unbreakable Impervious or resistant to moisture ,gas and bacteriaSlide 34: These metal container is prepared by using a different metals Aluminium Aluminium foil Tin Lead Collapsible metal tubeSlide 35: Aluminium is able to resist the corrosion . Aluminium foil is known as al-foil, alu -foil, It is also called as tinfoil. But it is not made from tin. or as silver paper although is not made from silver . Tin can be highly polished and is used as a protective coat for other metals in order to prevent corrosion or chemical action.Slide 36: TIN CONTAINERS Aerosol containersSlide 37: COLLAPSIBLE METAL TUBE It is a attractive container that permits controlled amounts to be dispensed easily with adequate protection of the product. If product is incompatible with base metal the interior surface is coated with wax material or lacquers or epoxy or vinylPAPER AND BOARD : PAPER AND BOARD Paper and board are used in various forms for packaging of pharmaceutical product Eg . cartons or corrugated board , labels, boxes and drums . Papers are either cellulose / natural fibre material It is biodegradable Strength depends on GSMSlide 39: AL- Foil Paper drum Carton box Laminate film Corrugated boxSealed tubes: Sealed tubesFILM : FILM Film : A thin plastic material which up to 0.010’’ thickness Sheet : A material above 0.010’’ thickness Laminate film : when two completely different films are combined with an adhesive . Composite film : When two more films are passed through the pair dies and compressed together is called composite film .Regenerated cellulose film (RCF): Regenerated cellulose film (RCF) These films resemble like paper and its moisture sensitive and not heat sealable .it is also called as cellophane. It may be coated with nitrocellulose Films and coating based on plastics : It is clear colored or opaque films with glossy surface . They are flexible strong and selable . Special films : it is made of LDPE, HDPE and are used for formation of bagsSlide 44: Now a days chemically treated paper called tetra pack paper used for storing milk products . CELLOPHANE PAPER TETRA PACKSACHETS: SACHETSUNIT-DOSE PACKAGING: UNIT-DOSE PACKAGING Unit - dose packaging is the packaging of a single dose in a nonreusable container. Strip packing Blister packing Backing material (al-foil)- LID Transparent BlisterBlister Packaging : Blister Packaging Blister package consist of transparent thermoformable plastic material and heat selable lacqured backing material with protective quality of total packageCOMPONENT OF BLISTER PACK: COMPONENT OF BLISTER PACK Thermoformable plastic material Rigid Polyvinyl chloride PVC / Polyethylene Polystyrene Polypropylene Cyclo olefin copolymers( coc ) Moisture protection substance Polyvinylidene chloride (PVDC / Saran ) Polymonochlorotrifluro theylene ( Adar) roll of plastic sheetTYPES OF BACKING MATERIAL (LID) : TYPES OF BACKING MATERIAL (LID) Push through packs :( PTP) The cavity is made from the plastic or aluminum and for making lid the same material as that of cavity or paper and paperboard is used. Peelable backing materials: eg . Paper or foil combination LIDSlide 50: lid tabletINTERMITTENT MOTION MACHINE : INTERMITTENT MOTION MACHINE aa A B c Mold E Pre heated station D In this machine each operation of forming / filling / sealing / die cutting is carried out in flat pattern station. A- thermo plastic roll B- Guide C- Hopper containing cap/tab D- Cavities E – Lid rollCONTINUOUS MOTION MACHINE : CONTINUOUS MOTION MACHINE F B C A G E DBLISTER PACKAGING MACHINE: BLISTER PACKAGING MACHINEBLISTER PACKAGING MACHINE : BLISTER PACKAGING MACHINEALU-ALU PACKING: ALU-ALU PACKING Child resistant container : These containers are difficult to open by child or elder patient. But adult can open it easily.STRIP PACKAGING MACHINE: STRIP PACKAGING MACHINEDIMENSION OF STRIPS : DIMENSION OF STRIPS The pocket size should be twice the tablet diameter and twice the tablet thickness. Length : L + 2 D Width : 3 times the diameter of capsule . The minimum sealing width should be 4mm from all sides of the strip 6 mm in between the two pocketsSlide 59: 1.VIBRATOR Which transports it through supply tubes to the finger device. 2.FINGER DEVICE The device grips the various pieces and centers them for their entry into the sealing. 3.SEALING ROLLER The temperature of sealing roller can be steadily maintained (125 -140 o c) because precise temperature control device is adopted.Slide 60: 4.SLTTING The column number and location of the slitting can be adjusted easily. 5.DRAG ROLLER T ense the strip, makes sure the sealing and cutting is perfect. 6.CUTTER The row number of cutting can be adjusted at will from 1 to 99 row and special device can make the cutting very precisely with very small noise. 7.PRODUCT Perfectly packed product.CLOSURES : CLOSURES Closures are the device which is used for open and close the container . Advantages : It prevents loss materials by spilling or volatilization It avoids the contamination of products It prevent the product from environmental condition .TYPES OF CLOSURES : TYPES OF CLOSURES Plug type Crown type Push fit type Screw closuresSlide 63: Plug type : The closure of this type is a push fit in to the neck of the container . Eg. Cork or glass stopper . Crown cap : The cap is commonly used as crimped closure for beverage bottles .SCREW CLOSURES: SCREW CLOSURES These are very commonly use d . it consist of there components The cap The wad The liner Cap: It Is made of tin plate or aluminium meta. Sometimes it is used to close the container by screwing the cap on the neck Wad : It is seal which prevents the contamination of the product. Wad should be inert . Wads are made of rubber or silicone rubber Liner : It is made of metal foils ,rubber , plastic film and paper impregnated with a suitable resins wax or plastic .Slide 65: Cork : It is obtained from the bark of oak tree . cork is chemically inert and it doesnot impart any odor or flavor It is used rarely because of growth of mold. Glass : These closures are mainly used for reagent bottles in laboratories .Slide 66: Plastic : Plastic closures are available in different shape and size Metal : Metal closures are made of aluminium and tin plate RubberTypes of plastic closure of ointments tube : Types of plastic closure of ointments tubeSlide 68: Screw Cap Closure / Lug Flip top closure Closure with inner linerCROWN CORK ON GLASS BOTTLE: CROWN CORK ON GLASS BOTTLE Crimp on closure Inner plastic linerSlide 70: Rubber closure PUSH AND TURN PACK Roll on plifer capSlide 72: Child resistant closure Sprayer bottle closureSlide 73: Tamper evident closure are designed to prevent accident for safe packaging . Eg. Film wrappers Blister packs Bubble packs Wrappers Paper foil plastic packs Bottles with inner seals Tape seals Breakable cap ring system Sealed tubes Plastic blind end heat sealed tubes Sealed cartons Aerosol containersEVALUATION TEST : EVALUATION TESTPreparation specimen for powder glass test : Preparation specimen for powder glass test Rinse 6 or more container Dry them Crush into fragments Divide 100g of coarsely crushed glass into three equal parts Place one portion in mortar Crush further by striking 3 or 4 blows with hammer Pass through sieve no 20 then 40Slide 76: Transfer the retained portion & weigh excess of 10 g Spread it on glazz paper and remove iron particle with magnet Wash with six 30 ml of acetone Decant acetone Dry the contents for 20 mts at 140 0 c Transfer to dessicator Final specimen to be used in powdered glassPowder attack test : Powder attack test 10 gm specimen in a 250ml conical flask with high purity of water in bath at 90 o c Add 50 ml of purified water Autoclave for 10 mts Adjust temperature to 121 0c Reduce the heat and wait for cool Cool the flask in running water Decant waterSlide 78: Wash thee residue powdered glass Add the decanted washing to main portion Add 5 drops of methyl red solution Titrate immediately with 0.02 N sulphuric acid Record the volume of 0.02 N sulphuric acid Fragmentation test for rubber closures : Fragmentation test for rubber closures Place a 4ml of water in each of 12 clean vials Close a vial with closure and secure caps for 16 hrs Pierce the closure with 21 SWG hypodermic needle ( bevel angle of 10 inject 1ml water and 1ml air Repeat the operation 4 times for each closures ( use new needle for each closure) Count the number of fragment visible on the rubber Total number of fragment should not be morethan 10 except butyl rubberSELF SEALBILITY TEST FOR RUBBER CLOSURE ( VIALS ) : SELF SEALBILITY TEST FOR RUBBER CLOSURE ( VIALS ) Fill 10 vials with to nominal volume and close the vial with closure Pierce the cap 10 times at different size with 21 SWG hypodermic needle Immerse the vials in 0.1% w/v solution of methylene blue under reduced external pressure for 10 mts Restore the normal pressure and keep the container immersed for 30 mts Wash the vial . none of the vials should contained trace colored solution.Water attack test : Water attack test Rinse 3 or more containers twice with high purity water Fill each container to 90% of its overflow Cap all the flask autoclave for 60 mts Empty the content and pool the content in 250 ml conical flask to a volume of 100ml Add five drops of methyl red solution Titrate with 0.02 N sulphuric acid with warm Record the volume consumed ‘volume should not exceedLeakage test for plastic container : Leakage test for plastic container Fill 10 container with water and fit the closure Keep them inverted at RT for 24 hrs No sign of leakage from any containerSlide 83: Types of glass Types of test Limits size in ml Limits (ml of 0.20N) I Powdered glass All 1.0 II Water attack 100 0.7 III Powdered glass All 8.5 IV Powdered glass All 15.0 TYPES OF GLASS AND THEIR LIMITSWater vapour permeability test for plastic container : Water vapour permeability test for plastic container Fill 5 containers with nominal volume of water and seal Weigh each container Allow to stand for 14 days at RH of 60 at 20 -25 0 c Reweigh the container Loss of weight in each container should not be more than 0.2%Collapsibility test for plastic containers : Collapsibility test for plastic containers This test is applicable for those container which have to be squeezes for the withdrawl of the product a continue squeezing yields at least 90% of its nominal content at regular flow rate at ambient temperature .Slide 86: THANK YOU You do not have the permission to view this presentation. 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