1. Presented By Guided By:Mahesh K. Shinde Dr. R. J. Dias HOD, Dept. of PharmaceuticsM.Pharm -II nd sem.SINHGAD INSTITUTE OF PHARMACEUTICAL SCIENCES, LONAVALA 1

2. Packaging material for : Solid dosage form Liquid dosage form Sterile products Ophthalmic dosage form Transdermal drug delivery system Transnasal drug delivery devices 2 3. Glass Bottles type III glass and NP glass is used. Transparent and Amber coloured glass bottle It have strong and rigid Impermeable to water vaporsPlastic Bottle : Bottles made from polyethylene (HDPE),Polypropylene , Polystyrene . It is light weighted and non breakable.3 4. Blister packaging:The primary component of a blister pack is a cavity or pocket made from a formable web, usually a thermoformed plastic and a backingmembrane or a "lidding" seal of aluminum foilThe most basically Polyvinyl chloride (PVC) usedfor forming cavity or pocket.Others materials used - polychloro-trifloro-ethylene- cyclic olefin copolymersfor moisture prevention 4 5. Strip Packaging1. Strip packs present an alternative form of packfor a unit dosage.2. This pack consists of one or two plies, made fromregenerated cellulose, paper, plastic, foil or combinationof these3. The use of high barrier material like aluminum foil orsaran-coated film with excellent seal formation formoisture-sensitive products.4. cellophane film -. -when transparency required. 5 6. Tests of strip and blister packaging1) Leakage testing and package integrity testingDip the packages in the pot containing the colored water and place the pot in the vacuum chamber. Apply the vacuum for strip packages and for blister packs for 30 sec. Return to the atmospheric pressure and remove the pot from the vacuum chamber. Examine the package for ingress of the water in to the package2) Pinholes and package integrity Pinholes are the common features of aluminum foil.It can be detected by water vapor permeation. High water vapor permeationindicates the high numbers of the pinholes.6 7. PouchesPlastic Pouches :1. Made from strong LDPE film2. With a re-sealable strip at the top, easy toopen and close Plastic Pouches3. It have Waterproof, tide proof, air proof andnon-poisonous property .Especially suitable for hospital and clinicAluminum pouches :1. It have tear strip facility Aluminium pouches2. It offers excellent barrier properties to themoisture, gas and light 7 8. Solids-Rectal (Suppository) :1) Aluminum Foil Offers the highest possible protection against moisture, oxygen, and light,. the aluminum suppository package takes the shapeof individual doses . Aluminum foil quality offers protection even under the mostdifficult climatic conditions. It serves Child resistant due to Non-transparent material Excellent appearance Have an easy opening feature with a peelable system, andtearing8 9. 2) Laminates for suppositories : It is made of Polyolefine, Aluminum, P.E. . It gives protection from moisture, gas,vopours,light The product is smooth, easy to tear, shape well,particularly suitable for temperature & humidity-sensitive suppository, It directly contacts suppository medicines, noabnormal toxicity, no physical and chemicalmatrix effects occurred9 10. Solids (Inhalation) Dry-Powder Inhaler : It is made of plastics such as polyethylene (HDPE),Polypropylene , polystyrene .How to use:1. Hold the base of the inhaler firmly and open the inhaler by turning the mouth piece in the direction of the arrows.2. Take a capsule out of the blister strip and. Place the capsule into the capsule cavity .3. Close the mouthpiece back to the closed position4. Press the bottom buttons with thumb and index finger at the same time . So that capsules are puncture & powder is dispersed .5. Insert the mouthpiece of the inhaler completely into your mouth, behind your teeth and on your tongue. Close your lips tight round the mouthpiece And Breathe in rapidly but steadily, as deeply as you can. 10 11. - Glass Or Plastic Bottle- Bottle With Spray Pump1)Capacity: 50ml2) Material: Bottle-polyethylene terephthalate;Sprayer-polypropylene3) Spray output: 0.05ml-0.20ml4) Bottle is tough , excellent strength and havegas & aroma barrier5) Used for body spray, oral spray, anti-bacterial 11 12. Bottle With Dropper Assembly : Dropper assemblies can be suppliedwith coloured caps glass type II is used Dropper glass is of Sodalimeglass(type III) and Neutral glass(typeI). Bottle capacity is from 2 to 100ml pipettes are up to 120mm in length 12 13. Collapsible tubes : It is made of metals like aluminum , tin and leadand plastics like low density polyethylene Material for cap is of high density polyethylene,polypropylene and pvc. Adv. Of metal collapsible tube - risk of contamination of portion remaining in the tube isminimum because inner material is not suck back 13 14. Collapsibility test for Injectable and Non-Injectable preparation( IP1996)-This test is applicable for those containers, which have to be squeezed for thewithdrawal of product.A container by squeezing yields at least 90% of its nominal contents at requireflow rate at ambient temperature. 14 15. Aerosol spray :Container: To withstand pressure 140-180 psig1) Tin plate container- it is sheet of steel plates electroplatedon both side with tin2) Aluminum container- it has seamless nature and greater resistance to corrosion(corroded by pure water and pure ethanol)3)Stainless steel container used inhalation aerosol - No coating required -extremely strong and resistant to most matter4)Glass container type I glass is usedValve1) Mounting cup / ferrule tin plate steel, Aluminum, Brass - it is used to attach the valve proper to container2) Valve body/Housing it is opening at the point of attachment of the dip tube. -- Nylon or delrin15 16. Dip tube allows the liquid to enter the valve- Polyethylene and polypropyleneGasket - it is seal between the valve cup andaerosol can .-Buna N and Neoprene rubberStem-Nylon and Delrin or metal like Brass , stainless steelSpring -Hold gasket in placeActuator is used to delivered the producttypes of actuator1) Spray orifice is 0.016 0.040 inch in dia.2) foam orifice is 0.070- 0.125 inch in dia. 16 17. Test of aerosolValve acceptance :The test procedure of metered valve having thefollowing value:54L or less, the limits are +/- 15%55 to 200L, the limits are +/- 10%1) Of the 50 individual deliveries, if four or more are outside the limits, the valvesare rejected.2) If three or two deliveries are outside the limits, another 25 valves are sampledand test is repeated. The lot is accepted if not more than one delivery is outsidethe specificationsWeight checking: : This is usually accomplished by periodically adding to the emptyaerosol containers, which after being filled with concentrate, are removed andaccurately weighed to check the accuracy of filling operation.17 18. Leak testing :The testing of efficiency of the valve closure is accomplished by passingthe filled containers through the water bath. Periodic checks are made of thetemperature of the water bath and the results are recordedSpray testing: :This method is based on the impingement of the spray on the paper thathas been treated with a dye-talc mixture. The particles that strike the paper causedye to go into solution and to be absorbed onto the paper. This gives the recordof spray. 18 19. Glass Ampoules : Type I (borosilicate glass is used) Packaging is 100% tamper proof. One point or colour break ring offers consistentbreaking force.Up to 3 colour can be placed for identification purpose.PVC mono films used for 20 packaging.MINIMUM TYPE OF FORMULATION QUALITY OFPACKAGE TYPECAN BE PACKED GLASS THATCAN BE USED Aqueous Injectables Of Any Type IpH Aqueous Injectables Of pHAmpouleType II Less Than 7Non-Aqueous Injectables Type III19 20. Sealing of ampoule:1) Tip sealing - seal is made by melting sufficient glass at the tip of the ampouleneckto form bead of the glass and close the opening.2) Pull seals - seals are made by heating the neck of rotating ampoule below thetip, then pulling the tip away to form small, twisted capillary prior to beingmelted closed Now a days, plastic ampoules for water for injection are available in themarket.20 21. Vial With Stopper : Vials are mainly used for multiple doseparenteral preparation and are provided withthe closure followed by aluminum seal toensure the perfect air tight packingAqueous Injectable Of Any pHType I Aqueous Injectables Of pH Less Vial Type II Than 7Non-Aqueous Injectables Type IIIClosure: Made from Butyl rubber ,Nitrile rubbers ,Neoprene, Siliconrubbers. It has compression recovery, coring resistance, solvantresistance, heat resistant , radiation resistance with very low 21water absorption and permeability properties. 22. Test of closure1) Fragmentation test : Place a volume of water corresponding to nominal volume minus 4 ml in each of12 clean vials.Close the vial with closure and secure caps for 16 hours.Pierce the closures with 21 SWG hypodermic needle (bevel angle of 10 to 14) andinject 1 ml water and remove 1 ml air.Repeat the above operation 4 times for each closure (use new needle for eachclosure). Count the number of the fragments visible to the naked eye. Total numbers of the fragments should not be more than 10 except butyl rubber where the fragments should not exceed 15.22 23. 2) Self sealability test for rubber closure applicable to multidose containersonly. Fill 10 vials with water with nominal volume and close the vials with closure, securethe cap.Pierce the caps 10 times at different sites with 21 SWG hypodermic needle.Immerse the vials in 0.1% w/v methylene blue solution under reduced externalpressure (27K Pa) for 10 mins.Restore the normal pressure and keep the container immersed for 30 mins.Wash the vials. None of the vials should contain trace of colored solution3) Closure efficiencyPutting liquid in pack, inverting and applying a vacuum. A poor seal is detected byliquid seeping. 23 24. - Pre-Filled Syringe: It is used for small volume parenteralpreparation. Reduction of medication errors like drugoverfill. It gives Increased assurance of sterility24 25. Blow-fill-seal Technology : The basic concept of blow fill seal (BFS) is that a container isformed, filled, and sealed in a continuous process without humanintervention, in a sterile enclosed area inside a machine. Plastic containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used for containers because ithas greater thermo stability which is further sterilized byautoclaving.25 26. A ) Thermoplastic resin is extruded into a tubular shape called a parison.B) When the parison reaches the proper length, the mold is closed and the parisonis cutC)The blow-fill nozzle is lowered into the parison and by blowing sterile filteredcompressed air into the parison and expanding it against the walls and the sterile productis metered into the container through the fill nozzle.D) Mold comes close at the top and hermetically seal the container.E)The mold opens, and the formed, filled and sealed container is conveyed out of the machine26 27. Sterile plastic devices :Irrigation solution container : It is made of LDPE , Polyolefin , polypropylenes Avoid hanging breakable glass It is light in weight, transparent, impermeable to water Material have high boiling point so that it issterilizable . 27 28. I.V. Infusion : It is made of acrylonitrile butadiene styrene Spike is made of nylon tube is made of polyvinyl chloride Niddle adapter is made of polymethacrilate Catheter: Catheter is inserted into a body cavity, duct, vessels. It is made of Silicone because it is inert and unreactive to body fluids and a range of medical fluids with which it might come into contact. 28 29. Disposable syringe : material used are polycarbonate, polyethylene, polypropylene. Material used for piston are natural rubbers, butyl rubbers for sliding well Silicone and floroelastomer is more long lived than butyl rubbers.. They have property of abrasion resistance, radiation resistance, excellent self-life properties. 29 30. Tests on the plastic containers1 ) Leakage test for Injectable & Non-Injectable(IP 1996)Fill the 10 containers with water and fit the closure. Keep them inverted at RT for 24 hours.No sign of leakage from any container.2) Water vapor permeability test for injectable preparation(IP 1996)Fill the 5 containers with nominal volume of water and seal.Weigh the each container.Allow to stand for 14 days at RH of 60 + 5% at 20 c to 25 c.Reweigh the container.Loss of the weight in each container should not be more than 0.2%. 30 31. Test Toxicity Evaluation:1) Implanting small pieces of plastic material intramuscularly in rabbits2) Injecting the eluates using the sodium chloride injection with or withoutalcohol intravenously in the mice and injecting the eluates using thepolyethylene glycol 400 and oil intraperetonially in mice3) Injecting all four eluates subcutaneously in rabbitsThe reaction from the test sample must not be significantly grater than nonreactive control sample. 31 32. 1) Plastic bottles: Material used for plastic bottle islow density polyethylene, HDPE Consumers often get too little with each squeeze LDPE used in ophthalmics usually contains minimal additives for caps are harder plastic materials such as LLDPE, HighdensityP.E. ,or Polypropelene is used. 2) Collapsible Tube 3) blow-Fill-Seal Plastic Bottle32 33. Backing Films -To protect the active layer and safeguard the stability of the systemThe most common materials used- polypropylene, polyethylene (both high and low density), saran, polyesters,PVC,and nylon. Semi-Permeable Membranes - act as a rate-limiting membraneMaterial used are Ethylene Vinyl Acetate Membranes (EVA): PolyethyleneMembranes33 - The permeability depends on the percentage of the EVA - the higher the 34. Pouching MaterialsThere are three main layers in the composite materialsused for pouches:1) Internal plastic heat sealable layer, - material used -polyethylene, surlyn2) Aluminium foil layer Its important role in protecting the product from light and oxygen.3) External printable layer. It is used to achieve a better finishing and printing qualitymaterial- Paper or polyester film is used 34 35. Tests of T.D.D.S. :1) Thickness : The thickness of transdermal film is determined by traveling microscope, dial gauge, screw gauge, micrometer at different points of the film.2) Uniformity of weight :Weight variation is studied by individually weighing -10 randomlyselectedpatches and calculating the average weight. The individual weightshouldnot deviate significantly from the average weight3) Moisture Uptake: Weighed films are kept in a desiccator at roomtemperature for 24 h. These are then taken out and exposed to 84%relative humidity using saturated solution of Potassium chloride in a desiccator . % moisture uptake is calculated as-35 % moisture uptake = Final weight Initial weight X 100 36. Kurve technology : By this it is possible to deliver drug tothe entire nasal cavity as well asolfactory region and paranasal sinuses It increases nasal residence time andreduses the deposition of compound inlungs and stomach36 37. Opti-nose device : In this , air is blown out of the container andsealing nozzle is used its direct flow of air innose It gives bi-directional flow so that it preventsdeposition of drug in lungs. 37 38. Direct-haler device :for moisture protection Transparenc y of divice for drug visibilityfor turbulentdispersion of dose38 39. Packaging materials are varies as the dosage form ischanges.. By using different packaging device we can target drugto specific site. We can protect the drug from external environment withhelp of packaging material. 39 40. Lachman, Libarman; The theory and practice ofindustrial pharmacy, third edition, varghese publishinghouse Jain U.K., Nayak S.; Pharmaceutical packagingtechnologyPharmaMed Press Dean D.A., Hall I.H.; Pharmaceutical packagingtechnologyTaylor and Francis Hanlon F. J., Handbook of package engineering, 40 41. All41 42. ?42