Umang pharmaceutical packaging..b.k.mody goverment pharmacy college rajkot


Published on

pharmaceutical packaging and packaging materials and it also contains the evaluation of all the pharmaceuticals packaging materials with the regulatory guidelines..

Published in: Health & Medicine, Business

Umang pharmaceutical packaging..b.k.mody goverment pharmacy college rajkot

  1. 1. PACKAGING: It is the science, art and technology of enclosing or protecting product for distribution, storage, sale, and use. It also refers to the process of design, evaluation and fabrication of the packages. PHARMACEUTICAL PACKAGING: It can be defined as means for providing protection, presentation, identification, information, convenience, compliance and compatible unit, which maintain the integrity and stability of the product
  2. 2.  WELL CLOSED CONTAINER: It protects the contents from extraneous solid and from loss of the article under the ordinary condition of handing, shipment, storage and distribution .  TIGHT CONTAINER: It protects contents from the contamination by extraneous liquid, solid or vapor from loss of the article and from efflorescence, deliquescence or evaporation.  HERMETIC CONTAINER: It is impervious to air or any other gas under the ordinary condition of handing, shipment, storage and distribution.  LIGHT RESISTANT CONTAINER: It protects the contents from the effect of light. A clear and colorless or translucent container may be made light resistant by means of opaque covering.  TAMPER EVIDENT CONTAINER: The container or individual carton of a sterile article intended for ophthalmic or optic use which cannot be used without destruction of the seal.
  3. 3.  Stability  Compatibility with the contents  Strength of container and the degree of protection required  Moisture-proof.  Resistance to corrosion by Acids or Alkalis  Resistance to grease  Protection against salt  Resistance to microorganisms  Resistance to insects and rodents  Resistance to differences in temperature  Protection against light, fire and pilferage  Odor retention and transmission.  Cost  Machine suitability of packaging and the filling method  Convenience of the packaging for the physician, pharmacist and finally the patient (size, weight, method of opening/re-closing, legibility of printing)
  4. 4. Primary packaging Secondary packaging Tertiary packaging E.g. Blister , Strip Sachets & pouches Collapsible tube Heat sealed membranes & closures O intm e nt tube s Vials, am po ule s Pre -fille d syring e s Ae ro so lco ntaine rs Pre -fille d inhale rs E.g. cartons Prescribe dispensing box Corrugated boxes Paper drums Shipping containers Injection trays E.g. Intermediate bulk container Slip sheet Edge protector
  5. 5. PRIMARY PACKAGING MATERIALS GLASS Vials Ampoules Tubular vials Bottles Dropper bottle Aerosol containers PLASTIC Plastic jar Plastic tube Bottles Syringes Bags Laminates Pouches Lids, taps, stems, METALS Collapsible tube Laminated tube Aerosol containers PAPER Labels, Display units Pouches Laminates Cartons Boxes Foil Gum tapes Paper drums RUBBER Closures Vial wrappers Caps Plungers
  6. 6. TYPES OF PACKAGING : Primary packaging is the material that envelopes the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. Primary packaging :
  7. 7. Secondary packaging Is outside the primary packaging-perhaps used to group primary packages together.
  8. 8. Tertiary packages: Is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container.
  9. 9. MATERIALS USED FOR MAKING OF CONTAINERS: GLASS- e.g.bottles,vials,ampules,syringes,i.v containers, aerosol containers. PLASTIC- e.g.bottlespouches,tapes,tubes,aerosolcontainers,laminates.
  10. 10. RUBBER- e.g. closures, caps,vialswrapers,plungers. Metals- e.g. collapsabletubes,foils,needles,aerosol containers
  11. 11. Paper or cardboard- e.g. secondary packaging labels,inserts,displayunits,pouches,laminates,cartons,carrogated boxes,foils,paper drums
  12. 12. Composition of glass: Glass is composed principally of sand, soda ash, lime stone and cullet. Sand is almost pure sillica,soda ash is sodium carbonate, lime stone is calcium carbonate. Cullet is broken glass that is mixed with the batch and acts as fusion agent for the entire mixture. GLASS CONTAINERS:
  13. 13. Manufacture of glass: The four basic processes used in the production of glass are:- 1.Blowing uses compressed air to form the molten glass in the cavity of metal mold. 2.In drawing, molten glass is pulled through dies or rollers that shape the soft glass. 3.In pressing mechanical force is used to press the molten glass against the side of a mold. 4.Casting uses gravity or centrifugal force to cause molten glass to form in the cavity of mold.
  14. 14. TYPES OF GLASSES: Type I-borosilicate glass It is highly resistant glass. It has high melting point so can with stand high temperatures. It is more chemically inert than the soda lime glass. It can resist strong acids,alkalies and all types of solvents. Reduced leaching action. USES: Laboratory glass apparatus. For injection and water for injection.
  15. 15. Type II-treated soda lime glass Type II containers are made of commercial soda lime glass that has been dealkalised or treated to remove surface alkali. The de-alkalizing process is know as sulfur treatment. Sulfur treatment neutralizes the alkaline oxides on the surface, rendering the glass more chemically resistant. Uses: Used for alkali sensitive products. Infusion fluids, blood and plasma. Large volume container.
  16. 16. Type-III regular soda lime glass Containers are untreated are made of commercial soda lime glass of average are better than average chemical resistance. It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances. Flakes separate easily. USES: For all solid dosage forms. For oily injections.
  17. 17. Type NP-general purpose soda lime glass Containers are made of soda lime glass supplied for non parental products, intended for oral or topical use. USES: FOR ORAL USE. TOPICAL PURPOSE.
  18. 18. GLASS: Advantage disadvantage They are strong and rigid. They are brittle and break easily. They are transparent which allows visual inspection. They may crack when subject to sudden changes in temperatures They are available in various shapes and sizes. They are heavier in comparison to plastic containers They can withstand with temperature and pressure during sterilization. They are economical and readily available. They can protect the photosensitive medicaments from light during their storage.
  19. 19. PLASTIC CONTAINERS: Plastics are synthetic polymers of high molecular weight. Plastics as packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality and the freedom to design. Plastic containers are extremely resistant to breakage and offer safety consumers.
  20. 20. PLASTIC ARE OF TWO FROMS: 1.Amorphous plastic. 2.Crystalline plastic. AMORPHOUS PLASTIC: They give good transparency. They are hard but posses little brittleness. They are more permeable to gases and vapour. They are of less inert.
  21. 21. CRYSTALLINE PLASTICS: For photo sensitive drugs this type of plastics are selected. They are opaque. They are more flexible. They are less permeable to gases and vapour. They are more inert.
  22. 22. Plastic containers for pharmaceutical products are primarily made from the following polymers:  polyethylene  polypropylene  poly vinyl chloride  polystyrene  polymethyl methacrylate  amino formaldehyde  poly amides
  23. 23. Thermoplastic type :- On heating, they are soften to viscous fluid which hardens again on cooling. e.g. polyethylene ,PVC ,Polystyrene, polypropylene, Polyamide, Polycarbonate. Thermosetting type :- When heated , they may become flexible but they do not become liquid. Phenol formaldehyde ,urea formaldehyde, melamine formaldehyde TYPES OF PLASTICS:
  24. 24. 1) Polyethylene:  Its is flexible, very light but tough plastic.  It is impermeable to water vapour and does not deteriorate with age unless it is exposed to sunlight for long time.  It has permeability to certain oils and preservatives.  Its melting point being in the range of 1100 to 1500 c  It has high melting point and can sterilized by autoclaving.  It is divided into 1. HDPE (HIGH DENSITY POLYETHYLENE ) 2. LDPE ( LOW DENSITY POLYETHYLENE )  HDPE : Inert, low cost, tough in nature.  LDPE : Inert, great resistant to gases, low cost.
  25. 25. POLYVINYL CHLORIDE (PVC ): It is less flexible , heavier and more permeable to water vapour as compared with normal has high clarity and not effected by sunlight. It is used for preparing eye ointment tubes.
  26. 26. POLYMETYL METOCARYLATE(PMMA): It is hard , strong but light, transparent plastic. It softens at about1000 c. It is used for preparing bottles and tubes.
  27. 27. POLYSTYRENE: It is a hard, rigid , light material. It can be easily molded into any shape. So it is used for preparing bottles, tubes , jars , boxes and syringes.
  28. 28. POLYPROPYLENE: It is similar to high density polythene. It is very light and heat resistant. Its melting point is 1700 c It has high melting point and can sterilized by autoclaving. So it is used for preparing squeeze bottles, tubes, and syringes.
  29. 29. POLYCARBONATE: It is transparent, has high impact strength and very good heat resistance. It is used in the preparation of surgical equipment.
  30. 30. Advantage Disadvantage They are light in weight and can be handled easily. They are permeable to water vapour and atmospheric gases They are transported easily. They are poor conductor to heat. They are unbreakable. They may absorb chemical substances, such as preservative for solutions. They available in various shapes and sizes. They are resistant to inorganic chemicals. They are relatively expensive. PLASTICS:
  31. 31. DRUG-PLASTIC CONSIDERATIONS A packaging system must protect the drug without altering the composition of the product until the last dose is removed. Drug-plastic considerations have been divided into five categories: 1.Permeation 2.Leaching 3.Sorption 4.Chemical reaction 5.Alteration
  32. 32. Permeation: It is the transmission of gases, vapors or liquids through plastic packaging material. Permeation of water vapor and oxygen through plastic wall into the drug is a major problem is the dosage form is sensitive to hydrolysis and oxidation. The volatile ingredients might change when stored in plastic containers and the taste of the medicinal products may change for the same reason of permeation.
  33. 33. Leaching: Some plastic containers have one or more ingredients added to stabilize it, these may leach into the drug product. Problems may arise with plastics when coloring agents are added in small quantities to the formula. Particular dyes may migrate into the parental solution and cause a toxic effect.
  34. 34. Sorption: This process involves the removable of constituents from the drug product by the packaging material. The therapeutic efficacy of the product may be reduced due to sorption. Sorption may change the chemical structure, Ph., solvent system, concentration of active ingredients and temperature etc…
  35. 35. Chemical reactivity: Certain ingredients in plastic formulations may react chemically with one or more components of the drug product. Even in micro quantities if incompatibility occurs may alter the appearance of the plastic or the drug product.
  36. 36. Modification: The physical and chemical alteration of the packaging material by the drug product is called modification. Some solvent systems found to be considerable changes in the mechanical properties of the plastics. For example oils have a softening effect on polyethylene, hydrocarbons attack polyethylene and PVC.
  37. 37. METALS: Metals are used for construction of containers. The metals commonly used for this purpose are aluminum ,tin plated steel, stainless steel, tin and lead.
  38. 38. ADVANTAGES: DISADVANTAGES: They are impermeable to light, moisture and gases. They are expensive. They are made into rigid unbreakable containers by impact extrusion. They react with certain chemicals. They are light in weight compared to glass containers. Labels can printed directly on to their surface. METALS:
  39. 39. COLLAPSIBLE TUBES METAL •The collapsible metal tube is an attractive container that permits controlled amounts to be dispensed easily, with good reclosure,and adequate protection of the product. •It is light in weight and unbreakable and lends itself to high speed automatic filling operations. •Any ductile metal that can be worked cold is suitable for collapsible tubes, but the most commonly used are tin, aluminium and lead. Tin is most expensive and lead is cheapest.
  40. 40. Tin: Tin containers are preferred for food, pharmaceuticals and any product for which purity is considered. Tin is the most chemically inert of all collapsible metal tubes.
  41. 41. Aluminum: Aluminum tubes offer significant savings in product shipping costs because of their light weight. They are attractive in nature.
  42. 42. Lead: Lead has the lowest cost of all tube metals and is widely used for non food products such as adhesives,inks.paints and lubricants. Lead should never be used alone for anything taken internally because of the risk lead poison. With internal linings, lead tubes are used for products such as chloride tooth paste.
  43. 43. CLOSURE: A closure is the part of the package which prevent the contents from escaping and allow no substance to enter the container. Closures are available in five basic designs 1.Screw on, threaded or lug 2.Crimp on(crowns) 3.Press on(snap) 4.Roll on and 5.Friction
  44. 44. Threaded screw cap: When a screw cap is applied, its threads engaged with the corresponding threads molded on the neck of the bottle. The screw cap is commonly made of metal or plastics. The metal is usually tin plate or aluminum and in plastic is thermoplastic and thermosetting material.
  45. 45. Lug cap: The lug cap is similar to the threaded screw cap and operates on the same principle. It is simply an interrupted thread on the glass finish, instead of a continuous thread. Unlike the threaded closure, it requires only a quarter turn. The lug cap is used for both normal atmosphere pressure and vacuum pressure closing.
  46. 46. Crown caps: This style cap is commonly used as a crimped closure for beverage bottles.
  47. 47. Roll-on closures The aluminum roll on cap can be seal securely, opened easily and resealed effectively. Resealable,non resalable and pilfer proof types of roll on closures are available for use on glass or plastic bottles.
  48. 48. Pilfer proof closures It is similar to roll on closure but has a greater skirt length. This additional length extends below the threaded portion and fastened to the basic cap by the series of narrow bridges. When the closure is removed the extra portion remains in the space on neck of the container, this indicates that the package has been opened.
  49. 49. RUBBER: Rubber is used mainly for the construction of closure meant for vials, transfusion fluid bottles, dropping bottles and as washers in many other types of product. BUTYL RUBBER: Advantages: Permeability to water vapor . Water absorption is very low. They are relatively cheaper compared to other synthetic rubbers. Disadvantages: Slow decomposition takes place above 1300 C. Oil and solvent resistance is not very good.
  50. 50. NITRILE RUBBER: Advantages: Oil resistant due to polar nitrile group. Heat resistant. Disadvantages: Absorption of bactericide and leaching of extractives are considerable. CHLOROPRENE RUBBERS: Advantages: Oil resistant. heat stability is good.
  51. 51. SILICON RUBBERS: Advantages: Heat resistance. Extremely low absorption and permeability of water. Excellent aging characteristic. Disadvantages: They are very expensive.
  52. 52. FDA approves the following configurations as tamper resistant packaging: 1.Film wrappers 2.Blister package 3.Strip package 4.Bubble pack 5.Shrink seals and bands 6.Oil, paper, plastic pouches 7.Bottle seals 8.Tape seals 9.Breakable caps 10.Aerosol containers
  53. 53. 1. Film wrapper Film wrapping has been used extensively over the years for products requiring package integrity or environmental protection. It is categorizes into following types: i. End folded wrapper ii. Fin seal wrapper iii. Shrink wrapper
  54. 54. End folded wrapper The end folded wrapper is formed by passing the product into a sheet of over wrapping film, which forms the film around the product and folds the edges in a gift wrap fashion. The folded areas are sealed by pressing against a heated bar. The materials commonly used for this purpose are cellophane and polypropylene.
  55. 55. Fin seal wrapper The seals are formed by crimping the film together and sealing together the two inside surfaces of the film, producing a fin seal. Fin sealing is superior than end folded wrapper With good seal integrity the over wrap can removed or opened by tearing the wrapper.
  56. 56. Shrink wrapper The shrink wrap concept involves the packaging of the product in a thermoplastic film that has been stretched and oriented during its manufacture. An L shaped sealer seals the over wrap The major advantage of this type of wrapper are the flexibility and low cost of packaging equipment.
  57. 57. BLISTER PACKAGE: Blister package provides excellent environmental protection, esthetically leasing and efficacious appearance. It also provides user functionality in terms of convenience ,child resistance and tamper resistance The blister package is formed by heat softening a sheet of thermoplastic resin and vacuum drawing the soften sheet of plastic into a contoured mold. After cooling the sheet is released from the mold and proceeds to the filling station of the machine. It is then lidded with heat sealable backing material
  58. 58. Peel able backing material is used to meet the requirements of child resistance packaging. The material such as polyester or paper is used as a component of backing lamination. Materials commonly used for the thermo formable blister are PVC, polyethylene combinations , polystyrene and polypropylene.
  59. 59. STRIP PACKAGE A strip package is a form of unit dose packaging that is commonly used for the packaging of tablets and capsule. A strip package is formed by feeding two webs of a heat sealable flexible through heated crimping roller. The product is dropped into the pocket formed prior to forming the final set of seals. A continuous strip of packets is formed in general.
  60. 60. The strip of packets is cut into desired number of packets. Different packaging materials used are: paper/polyethylene/foil/PVC.
  61. 61. BUBBLE PACK A bubble can be made usually by sandwiching the product between a thermo formable, extensible or heat shrinkable plastic film and a rigid backing material. The product is dropped into pocket which is then sealed with heat sealed coated paper board.
  62. 62. SHRINK BANDING The shrink band concept make use of heat shrinking characteristics of a stretch oriented polymer usually the PVC. The polymer is manufactured as a extruded oriented tube in a diameter slightly larger than the cap and neck ring of the bottle to be sealed.
  63. 63. BOTTLE SEALS A bottle may be made tamper resistant by bonding and inner seal to the rim of the bottle in such a way that the product can only be attained by destroying the seal. For pressure sensitive inner seals pressure sensitive adhesive is coated on the surface of the inner seal as an encapsulated adhesive.
  64. 64. TAPE SEALS It involves the application of glued or pressure sensitive tape or label around or over the closure of the package which is to be destroyed to obtain the product. Labels made of self destructing papers are available. But these cannot survive any attempt at removal once they have been applied.
  65. 65. BREAKABLE CAPS Breakable closures come in many different designs. The roll-on cap design of aluminum shell used for carbonated beverages. The bottom portion of the cap is rolled around the bottle neck finish. The lower portion of the cap blank is usually perforated so that it breaks away when the cap is unscrewed.
  66. 66. SEALED TUBES Collapsible tubes used for packaging are constructed of metal, plastic or lamination of foil, paper and plastic. Metal tubes are still used for products that required high degree of barrier protection. Most of these are made of aluminum. Extruded plastic tubes are widely used for products that are compactable and limited protection of plastic.
  67. 67. AEROSOL CONTAINER The aerosol container used for pharmaceutical products is usually made of drawn aluminum. A hydrocarbon propellant in its cooled liquid phase is added to the container along with the product. A spray nozzle contained in a gasket metal is crimped over the opening of the container. A dip tube is attached inside, draw the product through the spray nozzle.
  68. 68. The spray nozzles are usually metered to allow a specific dose to be dispensed with each spray.
  69. 69. SEALED CARTONS Folding paperboard cartons have been used as a secondary package for OTC products. The popularity is based on both functional and marketing considerations.
  70. 70. EVALUATION OF PACKAGING MATERIALS TESTS FOR GLASS CONTAINERS: 1) Powdered glass test 2) Water attack test Preparation of specimen for powdered glass test: Rinse 6 or more containers and dry them Crushed in to fragments Divide 100gms of coarsely crushed glass in to three equal parts
  71. 71. place 1 portion in a mortar Crush further by striking 3 or 4 blows with hammer Nest the sieves (# 20,40 at least) Empty the mortar in to sieve 20 Shake the sieves and remove the glass particles from # 20 and 40 Crush them again and sieve them Transfer the retained portion on # 50
  72. 72. Spread the specimen on a glazed paper and remove iron particles with the help of magnet Wash with 6 portions of 30ml acetone Dry the contents for 20mins at 140o c Transfer to weighing bottle and cool in a desiccator Final specimen should be used in powdered glass test
  73. 73. 1) POWDERED GLASS TEST: (acco rding to USP vo lum e 27 ) Transfer 10gms of prepared specimen in a 250ml conical flask digested previously with high purity water in a bath at 90o c Add to conical flask containing 50ml high purity water Cap all the flasks and auto clave Adjust temperature to 150o c Cold the temperature to 121o c for 30mins Cool the flasks under running water
  74. 74. Wash the residue powdered glass(4 times with 15ml purity water) Add the decanted washings to main portion. add five drops of methyl red solution. Titrate immediately with 0.02N sulphuric acid. Record the volume of 0.02N sulphuric acid. Volume does not exceed i.e. indicated in the USP as per the type of glass concerned
  75. 75. WATER ATTACK TEST:(USP) rinse 3 or more containers with high purity water fill each container to 90%of its over flow capacity cap all the flasks and autoclave for 60mints empty the contents and cool the contents in 250ml conical flasks to a volume of 100ml add 5 drops of methyl red solution titrate with 0.02N sulphuric acid while warm record the volume of 0.02Nsulphuric acid consumed volume should not exceed as indicated in USP as for type of glass
  76. 76. Type Types of the test Limits size(ml) Limits(ml of o.o2N) I Powdered glass test All 1.0 II Water attack test 100 or less 0.7 III Powdered glass test All 8.5 IV Powdered glass test All 15.0 STANDARDS:
  77. 77.  Hydrolytic Resistance (EP) • By titration of the extract solutions obtained under the conditions described for test A, B and C • TEST A : SURFACE TEST (hydrolytic resistance of the inner surfaces of glass container) • TEST B : GLASS GRAINS TEST (hydrolytic resistance of glass grains) • TEST C : ETCHING TEST ( To determine whether the containers have been surface-treated) • Limits for Glass Grains Test (Test B):
  78. 78.  Light transmission test • A spectrometer of suitable sensitivity is used to cut the section of glass container. The transmittance of the selection is measured and transmission of light is observed. • Maximum % of light transmission at any wavelength between 299nm and 450nm.  Arsenic: Use 35ml of solution prepared by procedure under water attack at 121ºC and test against std. arsenic. Limit is 0.1ug per g.
  79. 79. TESTS FOR PLASTIC CONTAINERS 1.Leakage test for plastic containers(non injectables and injectables 1996 IP): fill 10 plastic containers with water and fit the closure keep them inverted at room temperature for 24 hrs no sign of leakage should be there from any container
  80. 80. 2.WATER PERMEABILITY TEST FOR PLASTIC CONTAINERS(INJECTABLE PREPARATIONS IP 1996): fill 5 containers with nominal volume of water and sealed weigh each container allow to stand for 14 days at relative humidity of 60% at 20-250C reweigh the container loss of weight in each container should not be more than 0.2%
  81. 81.  Compatibility test  Compatibility components will not interact with the dosage form and may not show leaching. Regular screening is done by liquid chromatography, mass spectrometry, GC-MS etc. • Other changes like PH shift, precipitation, discoloration, which may cause the degradation of the product should be evaluated.
  82. 82. TESTS FOR RUBBER/RUBBER CLOSURES 1.FRAGMENTATION TEST(IP 1996): place a volume of water corresponding to nominal volume-4ml in each of 12 clean vials close vial with closure and secure caps for 16hrs pierce the closure with number 21 hypodermic needle(bevel angle of 10 to 140c)and inject 1ml water and remove 1ml air repeat the above operation 4 times for each closure count the number of fragments visible to naked eye Total number of fragments should not be more than
  83. 83. 2.SELF SEALABILITY TEST FOR RUBBER CLOSURES APPLICABLE TO MULTI DOSE CONTAINERS ONLY(IP 1996): fill 10 vials with water to nominal volume and close the vials with closures pierce the cap and closures 10 times at different places with no 21 syringe needle immerse the vials in 0.1 %W/v solution of methylene blue under reduced pressure restore the nominal pressure and keep the container for 30 min and wash the vials none of the vial should contain traces of colored solution
  84. 84.  Leakage testing and package integrity testing  Mainly two types of testing are involved for checking package integrity. Destructive type testing Dip the packages in the pot containing the colored water (15-25 c) and place the pot in the vaccum chamber. Apply the vaccum of 33K Pa for strip packages and 24K Pa for blister packs for 30 sec. Return to the atmospheric pressure and remove the pot from the vaccum chamber. Examine the package for ingress of the water in to the package
  85. 85.  Non-destructive type testing • This type of testing equipment is based on a dry pressure vaccum procedure followed by detection of pack distortion (deflection) or non-distortion, i.e. packs with effective seals become concave them convex as positive pressure changes to negative pressure, while leaking packs either do not change or show less or limited distortion, depending on the scale of the leakage.  Pinholes and package integrity • Pinholes are the common features of aluminium foil. It can be detected by water vapor permeation. High water vapor permeation indicates the high numbers of the pinholes.
  86. 86. • Testing of paper and board Air permeability: - Permeability is the mean air flow through unit area under unit pressure difference in unit time, under specific conditions, expressed in Pa-1s-1. • Tensile strength: - both wet and dry. The maximum tensile force per unit width that a paper or board will withstand before breaking. • COBB TEST: - This measures the mass of water absorbed by 1cm2 of the test piece in a specified time under a head of 1 cm of water. It is determined by weighing before and after exposure to the water, and usually quoted in g/m2
  87. 87. • Carton opening force: Hold the flat carton as delivered by its crease between thumb first figure and press. The carton should spring open in to the square position without the need for unreasonable force. • Compression: - Assessment of the strength of the erected package, thereby estimating the degree of protection that it confers on the contents.
  88. 88. • The following characteristics are common requirements of most regulatory agencies: 1.Product or preparation related requirements • Protection of the product • Protection of the consumer • Control of doses 1.Label related requirements • Information to the receiver • Legal control of the product
  89. 89. 3.Environmental aspects: •Packaging wastage •Ozone depletion 4.Consumer protection: •Child resistant closures •Tamper evident packaging
  90. 90. Packaging Concerns forCommon Classes of Drug Products Degree of Concern Associated with the Route of administration PACKAGING COMPONENT-DOSAGE FORM INTERACTION HIGH MEDIUM LOW HIGHEST Inhalation Aerosol and Solution ; Injectables Sterile powder and powder of injection HIGH Ophthalmic solution, susp., Transdermal Patches, nasal sprays LOW Topical solution ,susp. Aerosol, Oral sol.,susp. Topical Powders Oral Powders Oral Tablets and Capsule
  91. 91. • FDA packaging guidelines defines the types of containers to be used, dividing them into :- • Parentral containers (glass/plastic) • Nonparentral containers (glass, plastic & metal) • Pressurized containers • Bulk containers of API & drug products
  92. 92. • According to FDA guidelines, for submitting documents for packaging for human drugs and biological, the following are required. 1.Purpose: • Package must maintain standards, identity, strength, quality & purity for intended shelf-life • Full information needed • Type of container/closure • Suitability for intended use • Submission of packaging information & date.
  93. 93. 2. Environmental concerns: • With increased environmental concerns there has been a considerable pressure to reduce contamination of environment with particular concern on amount of packaging & its disposal. • Ozone depletion is also of concern with the use of pressurized containers. • Regarding this aspects, the increase in concerns has led to the European E Commission packaging waste directive which requires: Reduction in quantity of waste Reduction in harmfulness of waste Increase in reuse of packaging Recycling & recovery of packaging waste & Reduction of the total packaging to be disposed of.
  94. 94. • Description Overall general description of the container closure system and For each packaging component :  Name, Product code, Manufacturer, Physical description  Materials of construction  Description of any additional treatments or preparation. • Suitability Protection : Safety :  Light exposure  Chemical composition  Reactive gases  Extractables  Moisture permeation  Extraction/toxicological study  Solvent loss  Other studies as appropriate  Microbial contamination Compatibility : Performance :  Interaction  Functionality  Post approval stability studies  Drug delivery
  95. 95. Quality Control For Each Packaging Component Received by the Applicant  Applicant`s test and acceptance criteria  Dimensional and performance criteria  Method to monitor consistency in composition For Each Packaging Component Provided by the Supplier  Manufacturer`s acceptance criteria for release  Brief description of Mfg. Process Stability  Container closure system should be monitored for sign of instability. Applicant should investigate any observed change In the packaging system used in stability studies. If corrective action requires a change in an approved container closure system, a supplemental application should be submitted.
  96. 96. Child resistant packaging Elder friendly Temper proof packaging
  97. 97. • The packaging that excludes the entry of children of less than 5 years age but not adults to access the contents of the pack. • Legally : “ At least 80% of children between the ages of 20 and 42 months forming a test panel are unable to open the packaging within 10 minutes of receiving it.”
  98. 98. Some of the "elder-friendly" concepts we expect to see include the conversion to square- or rectangular-footprint bottles from cylinders--to facilitate container opening and to resist rolling off countertops. Unit-dose packaging itself would be a help. Other problem with geriatric patient is poor vision in dark in such cases glow-in-the dark inks can be used in printing packaging material.  Missing dose is still a common problem for which a specially printed strips are designed on which the day & time is printed at which the drug is to be taken.
  99. 99. • Tamper proof containers are those that resist the tampering of the product before consuming the product. • Tampering includes three aspects, Altering, Pilfering and Falsifying • They help in…. Receiving the products by patients “ as manufactured “ Preventing “ product browsing and sampling “
  100. 100. Film Wrappers Blister or Strip Packs Bubble Packs Heat Shrink Bands or Wrappers Foil, Paper, or Plastic Pouches Bottle Mouth Inner Seals Tape Seals Breakable Caps Sealed Metal Tubes or
  101. 101. • Reckitt Benkiser has launched the easily portable ‘handy tube’ version of its popular strepsils. • The new packaging is not only convenient to carry but also provides adequate humidity protaction during its shelf life.
  102. 102. • Catalent’s Delpouch starter kit packaging system, designed for topical treatments. • Delpouch measures the right amount of topical creams or ointment to simplify the application process.
  103. 103. • Cypack’s advance medication monitoring and report card systems, can record the time and date that a pill was taken based on when it is removed from its blister.
  104. 104. • Packaging company Amcor flexibles introduced a Child resistant blister pack, which is compliant to CR / Senior friendly regulations in the Europe and US.
  105. 105. • UK packaging producer, Burgopak’s sliding CR blister pack can only be opened by applying pressure at two separate points on the packaging. • Burgopak Healthcare & technology – won the award for the ‘most innovative child resistant packging design’ at the Pharmapack Paris exhibition on 16th feb. 2012.
  106. 106. • In august 2011, Keystone folding box company and Legacy pharmaceutical packaging launched their Ecoslide-RX sustainable compliance packaging. • The pack is made from 100% recycled material, using unbleached paperboard and a clay coated surface , designed to house blister packaging with a minimum of unsustainable film and foil. • It doesn’t require heat sealing in the mfg. process.
  107. 107. • A DISKUS® is a dry powder inhaler that holds 60 doses. • It features a built-in counter, so that you always know how many doses you have left in it.
  108. 108. • Give the importance of pharmaceutical packaging. ( July 2011,Dec 2010) • Classify packaging materials with examples. (Dec. 2010) • Discuss factors affecting selection of packaging material. (Dec. 2010)
  109. 109. • Write a note on child resistant and temper proof packaging. (July 2010) • Define pharmaceutical package. Enlist the criteria for selection of package type and packaging material. Classify the packaging materials. (July 2010) • Discuss the regulatory aspects for packaging materials. ( July 2011,Dec. 2010)
  110. 110. • D.A.Dean, E.R.Evans, Pharmaceutical Packaging Technology,Taylor and Francis, pg no.50-72 • G.S.Banker, Modern Pharmaceutics, fourth edition, Marcel Dekker,Inc. • E.J.Bauer, Pharmaceutical packaging Handbook, Informa Healthcare, pg no. 157-162 • James Swarbrick, Encyclipedia of Pharmaceutical Technology, volume 1, Third edition, Informa Healthcare.
  111. 111. • • www.aclan packaging .com