Quality Testing For Container, Closure And Secondary packaging Material

Types of container, types of closure, Types of secondary packaging material
Types of Good Quality
Evaluation
Advantages
Disadvantages
Applications

1. Quality Testing For Container, Closure And Secondary Packaging Material Presented by: Bhakti Dave M Pharm Sem – 1 Roll no: MQ002 Guided by: Ms. MANSI DHOLAKIA Assistant Professor Department of Pharmaceutics A Seminar on 1

2. COINTAINER Content Introduction Types of containers Their Good Qualities Material Used For Manufacture Of C ontainer And Their Composition Evaluation Of The Material Used For Making Of Container 2

3. Introduction Containers can be defined as an object that can be used to h old or transport something. OR Pharmaceutical container is a device that hold the pharmaceutical product and it may or may not be in direct contact with it. 3

4. CONTAINER A device in which drug is enclosed & in direct contact with the drug. QUALITY OF GOOD CONTAINER The container must be neutral towards the material which is stored in it. The container must not interact physically or chemically with the substance which it holds. It should help in maintaining the stability of product against the environmental factors which causes its deterioration. 4

5. It should be able to withstand changes in pressure and temperature. The material used for making for making of the container must be non- toxic. Surface of the container must be clear for easy labelling. Size of the container must be selected according to easy labelling. They should not allowed any loss of product during leakage , spoilage or permeation. 5

6. Types Of Container Single dose container Multi – dose container Well Closed Container Light resistance Container Air tight Container Aerosol Container 6

7. TYPES OF CONTAINERS Containers are divided in to following types on the basis of their utility: Well-closed containers: - A well-closed containers protects the contents from loss during transportation, handling, storage or sale. E.g. Ampoules and vials. Single dose containers : -These containers are used to supply only one of Medicament and hold generally parenteral Products. 7

8. 3 . Multi dose container: - These containers allow the withdrawal of dose at various intervals without changing the strength, quality or purity of remaining portion. These containers hold more than one dose and are used for injectable. E.g. Vials 4. Light-resistant containers: - These containers protect the medicament from harmful effects of light. These containers are used to store those medicaments which are photo-sensitive. 8

9. 5. Air –Tight Container: These are also called hermetic containers. These containers have Air- tight sealing or closing. These container protects the products from dust, moisture, and air. Where as air-tight sealed containers are used for injectable, air –tight closed container are meant for the storage of other product. 6 . Aerosol Containers: These containers are used to hold aerosol products. These containers have adequate mechanical strength in order to bear the pressure of aerosol packing. 9

10. Material Used For Manufacture Of Containers There are mainly four types of material used in manufacture of container. GLASS METAL PLASTIC RUBBER 10

11. (A) GLASS CONTAINER 11

12. Coloured Glass Containers It is obtained by the addition of small amount of metal oxide ,chosen according to the desired spectral absorbance. Principally glass is silicon dioxide tetrahedron whose physiochemical properties are altered by adding oxides of sodium, iron, Magnesium. 12

13. TYPES Of GLASS Type- 1 Borosilicate Glass It is highly inert type of pharmaceutical glass. It has high melting point so can with stand high temperature ranges. It can resist strong acids, alkalies and all types of solvents Reduced leaching action. Use: Laboratory glass apparatus. For Injection and water for injections. Widely used as glass ampoule and vials. 13

14. (2) Type 2- Treated soda lime glass 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 sulphur treatment. Sulphur treatment neutralize the alkaline oxide on the surface, rendering the glass more chemically resistance. Use: For alkali sensitive product Large volume container To produce container for eye preparation Infusion fluids, blood and plasma 14

15. (3) Type 3- Regular soda lime glass Containers are untreated are made of commercial soda lime glass. It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances. Flakes separate easily. Use: For all solid dosage forms. For oily Injection. For non aqueous parenteral products. 15

16. (4) Type 4- General purpose soda lime glass Containers are made of soda lime glass supplied for non parenteral product, intended for oral or topical use. Use: For oral use For solid , liquid preparations 16

17. Types of Glass Container Bottles Used in the dispensary for packaging of medicine which are available in sizes from 50 ml to 500 ml. Types: Amber metric medical bottles: widely used for packaging of oral medicine. 17

18. Ribbed oval bottle: are used to package various product that should not be taken orally. Widely used for packaging of liniments, lotion , inhalation and antiseptic lotion. 18

19. Dropper Bottles Eye drop and dropper bottles for ear and nasal use are hexagonal- shaped colour glass containers. They are fitted with cap , rubber, and dropper as the closure. The bottles are used at a capacity of 10ml to 20ml. 19

20. JARS Powdered and semi solid preparations are generally packed in wide mouthed cylindrical jars made of clear or amber glass. Jars varies from 15ml to 500ml. Jars are used for packing prepared ointments and pastes. 20

21. A mpoule An ampoule is a small sealed vial which is used to contain and preserve a sample, usually a solid or liquid. They are commonly made of glass, although plastic ampoules do exist. These are used for packing of parenteral solution intended for single use, glass ampoules are more expensive than bottles and other sample container. 21

22. Vials A glass or plastic container closed with a rubber stopper and sealed with an aluminium crimp. Vials are available for single dosing or for multiple dosing. Injections vials can be obtained in either neutral or soda glass an occasionally in treated soda glass. 22

23. Advantages Of Glass Container 23

24. Disadvantages of Glass Container 24

25. (B) PLASTIC CONTAINER Plastic are synthetic polymer of high molecular weight. Plastics are packaging have proved useful for a number of a reason i.e. - Ease with which it can be formed - Durability and Flexibility - The freedom to design Plastic containers are extremely resistant to breakage and offer safety consumer. 25

26. Drug – Plastic Consideration A packaging system must protect the drug without altering the composition of the product until the last dose is removed. Drug plastic consideration have been divided into five categories 26

27. Permeation It is the transmission of gases, vapour or liquids through plastic packaging material. Permeation of water vapour 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 medicinal products may change for the same reason of permeation. 27

28. Leaching Some plastic containers have one or more ingredients added to stabilize it, these may leach into the drug product. Problems may rise with plastic when colouring agents are added in small quantities to the formula. Particular dyes may migrate in to the parenteral solution and cause toxic effect. 28

29. Sorption This process involves the removal 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. 29

30. 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. Modifications: The physical and chemical alteration of the packaging material by the drug product is called modification. For ex,. oils have a softening effect on polyethylene, hydrocarbon attack polyethylene and PVC. 30

31. Types Of Plastic There are two types of plastics: (1) Thermo plastic (2) Thermo sets Plastics (1) Thermo plastic: These are soften by heat and can be moulded. Thermoplastic polymers have been established as packaging material for sterile preparations such as large volume parenteral, ophthalmic solutions and also small volume parenteral. Examples are acrylic, polypropylene, polystyrene polythene and PVC. 31

32. (2) Thermo sets Plastics: These are formed by heat process but are then set and cannot change shape by reheating. Harden reversibly by cross linking Good examples are Melamine, Bakelite, Polyester and epoxy resins. 32

33. Other Classifications AMORPHOUS PLASTIC CRYSTALLINE PLASTICS They give good transparency They are opaque They are hard but posses little brittleness They are more flexible They are more permeable to gases and vapour They are less permeable to gases and vapour They are of less inert They are more inert 33

34. Plastic Containers For Pharmaceutical Products Are Made From The Polymers Polyethylene Polypropylene Poly Vinyl Chloride Polystyrene Poly Methyl Methacrylate Amino formaldehyde Poly Carbonates 34

35. Types Of Plastic Container Plastic Ampoules Advantages : Breaking is easy, no shreds, no sharp edges, no danger for scars or cuts of the skin. Plastic ampoules is not fragile , no need for special handling with care during shipment, storage or the final application. Filling up doesn’t need the expensive and hazardous technology of flame welding. 35

36. It is easy and energy efficient on automatic process machines, with high precision of dosing The raw material is environmental friendly and fully recyclable polypropylene , size range is -1.5 ml, 3ml, 5ml, 7ml, 11ml. Disadvantages: Not as transparent as glass Leaching may occur Difficult in sterilization Can not tolerate high temperature range 36

37. Plastic Vials Plastic vials often used to store medication as liquids, powders or capsules. They can also be used as sample vessels, for instance, in auto samplers devices in analytical chromatography. Modern vials are often made of plastics such as polypropylene. 37

38. Plastic Tubes During the last decade, plastic blood collection tubes have been progressively replacing glass tubes. Plastic tubes are not only less expensive but also safer than glass tube, because they are less likely to break. They have been shown to influence the measured concentrations or stabilities of several drugs. 38

39. PVC Collapsible Bags It is the part of large volume parenteral products (100ml to 1000ml per day) containers. These are used to pack most infusion fluids. They are design with a port of attachment of administration set and additive port for the addition of small volume parenteral fluid. 39

40. Semi Rigid Polythene Containers These containers are used for different volume of parenteral products: - 100ml for electrolyte solution - 3 litre for total parenteral nutrition solution - Up to 5ml for dialysis solution 40

41. Advantages Of Plastic Containers 41

42. Disadvantages O f Plastic Container 42

43. (3) METAL Metals are used for construction of containers. Advantages: They are impermeable to light, moisture and gases They are made into rigid unbreakable containers by impact extrusion They are light in weight Disadvantage: They are expensive They react with certain chemicals 43

44. These metal containers are prepared by using different metals Aluminium Aluminium Foil Tin Lead Stainless steel 44

45. METAL COLLAPSIBLE TUBES TIN Aluminium lead -Most expensive -light in weight -cheaper than other materials -Most chemically -Provides -Should never used alone Intern of all metal attractiveness of for anything taken internally Collapsible tubes tin at low cost because of chances of lead poisoning. 45

46. Aluminium : It is able to resist the corrosion . Aluminium tubes offers significant savings in product shipping costs because of their light weight. They are attractive in nature. Aluminium Foil: It is also called aluminium – foil It is also called tin foil but it is not made from tin. 46

47. TIN: Most expensive and can be highly polished It is used as a protective coat for other metals in order to prevent corrosion or chemical reaction. Tin containers are preferred for food, Pharmaceuticals and any product for which purity is considered. 47

48. LEAD: Lead has the lowest cost of all tube metals and is widely used for non food products such as adhesive, inks, paints and lubricants. Lead should never be used alone for anything taken internally because of the risk lead poison. 48

49. Stainless steel: Chromium (12 to 14%) and Nickel up to 0.7% are widely used for manufacturing of equipment's. 49

50. (2) Synthetic rubber: Have fewer additives and thus fewer extractable and tends to experience less sorption of product ingredients. Are less suitable for repeated insertion of needle because they tend to fragment or core pushing small particles of the rubber in to the product. E.g. Silicone , butyl , bromobutyl , chlorobutyl etc. Silicone is least reactive but it does experience permeability to moisture and gas. Soften rubber experience less coring and reseal better, harder rubber are easier to process on high speed packaging lines. 50

51. TESTING OF CONTAINERS: For Glass: Powder glass test Water attack test Light transmission test For Plastic: Leakage test Permeation test Collapsibility test Test for clarity of aq. Extract etc. Biological testing 51

52. Evaluation Of packaging Materials Test For Glass Containers Powdered glass test Water attack test Light transmission test Preparation of specimen for powdered glass test: Rinse 6 or more containers and dry them Crushed in to fragments Divided 100gms of coarsely crushed glass in to three equal parts 52

53. 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 53

54. Spread the specimen on a glazed paper and remove iron particles with the help of magnet Wash with 6 portion of 30 ml acetone Dry the contents for 20mins at 140c Transfer to weighing bottle and cool in desiccator Final specimen should be used in powdered glass test 54

55. (1) POWDERED GLASS TEST: (according to USP ) Transfer 10gms of prepared specimen in a 250ml conical flask digested previously with high water in bath at 90℃. Add to conical flask containing 50ml high purity water Cap all the flasks and auto clave Adjust temperature to 150 ℃ . Cold the temperature to 121 ℃ for 30mins Cool the flasks under running water 55

56. Wash the residue powdered glass (4 times with 15ml purity water) Add the decanted washing in main portion Add five drops of methyl red solution Titrate immediately with 0.02 N sulphuric acid Record the volume of 0.02 N sulphuric acid Volume does not exceed i.e. indicated in the USP as per the type of glass concerned 56

57. (2) 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 60 min Empty the contents and cool the contents in 250ml conical flask to a volume of 100ml Add 5 drops of methyl red solution 57

58. Titrate with 0.02 N sulphuric acid while warm Record the volume of 0.02 N sulphuric acid consumed Volume should not exceed as indicated. in USP as for type of glass 58

59. (3) 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. 59

60. TEST FOR PLASTIC CONTAINERS (1) Leakage test for plastic containers (non injectable and injectable 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 60

61. (2)WATER PERMEABILITY TEST FOR PLASTIC CONTAINERS (INJECTABLE PREPARATION IP 1996): Fill 5 containers with nominal volume of water and sealed Weight each container Allow to stand for 14 days at relative humidity of 60% at 20-250℃ This test is applicable to the containers which are to be squeezed for removing the contents . A container by collapsing inward during use, yield at least 90% of its normal contents at the required rate of flow at ambient temperature. 61

62. (4) CLARITY TEST Test is applicable to containers of oral liquids, unlabelled, unmarked portion from suitable containers are randomly selected. These portion are cut in to strips and washed twice with distilled water for 30 sec. &then water is drained. Strips are transferred to a clean flask (previously washed with chromic acid & water0. Added 250ml of distilled water. The flask is covered & autoclaved for 30 min. at 120℃. Inference- extract content are cooled & examined. It should be colourless & free from turbidity. 62

63. (5) BIOLOGICAL TOXICITY TEST In vitro test : extract placed in contact with mammalian cells to check to toxicity. In vivo test: systemic inj. Test- Mice Intracutaneous inj. – Rabbit Implantation test & eye irritation test - Rabbit 63

64. CLOUSURE Content Introduction Purpose of closure Classification of closure Material employed for formation of closure Quality control of closure 1. Test for alkalinity 2. T urbidity 3. For rubber closure 4. Child test 64

65. Purpose Of Closure Retain the content. Provides a barrier to dirt, oxygen, moisture, etc. Keeps the product secure from undesired and premature opening. Provides a means of reclosing or reusing the container. Assists in dispersing and using of product Minimizes the effect of change of surroundings such as changes of relative humidity, temp, or pressure. Provides a totally hermetic seal. This is a closure that permits no exchange between the contents and outside of the pack. 65

66. Classification Of Closure: CAP TYPE Plane or Snap fit Threaded or Screw Cap (a) Continuous (b) Lugged (B) Plug Type (C) Crown Type (D)Roll On (E) Pilfer Proof (F) Over Cap (G) Child Resistance 66

67. (1) CAP TYPE In this form, closure is an external cap over the neck. These are used to secure the closure to the container in order to maintain the integrity of the seal under normal conditions of handling and storage. 67

68. Plain or snap fit: In this the cap is pressed to seal It closes with a click Can be applied very quickly 68

69. Threaded or Screw Cap: It is mechanical device which is screwed on and off a container Either continuous threads or lugs are used It must be engineered to be cost effective Provide an effective seal Compatible with the contents Complies with product, package, environmental laws and regulations. 69

70. Screw cap consist of 3 components Cap Wad Liner Cap: may be of metal, usually tin plate or aluminium or may also be a plastic material which may be of thermosetting type. Plastic caps are more beneficial as compared to metal caps as they are capable of resisting corrosion & do not contaminated the product. 70

71. (b) wad: It should be effective to provide satisfaction seal and inert to avoid contamination of the product. Silicon rubber can be used but in practice wads are commonly of cork composition. (c) Liner: must be inert. Material that are used include metal foils, plastic films, rubber or paper impregnated with a suitable resins, wax or plastics 71

72. Continuous- When cap is applied , it’s threads are engaged with the corresponding threads molded on the neck of the bottle. For opening , closure is rotated. 72

73. (2) Lugged : Similar to threaded screw cap and operates on the same principle. It is simply an interrupted thread on the glass finish, instead of a continuous thread. It required only ¼ th rotating. 73

74. (2) PLUG TYPE: It is push fit into the neck of container. E.g. Cork or glass stopper, but both of these have been replaced by plastic stopper. 74

75. (3) CROWN CAP: These are shallow metal caps that are crimped in to locking position around the head of the bottle. Generally made up of tin. 75

76. (4) ROLL ON: Requires a material that is easy to form. The roll on caps can be sealed securely , opened easily and reclosed effectively. It finds wide application in the packaging of food, beverages , chemical, and pharmaceutics. 76

77. (5) PILFER PROOF: It is similar to roll on closure but has a greater skirt length. This addition length extends below the threaded portion and fastens 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. The user can reseal the closure but the detached bond indicates that the package has been opened. 77

78. (6) OVER CAP: These are additional closures for sample dose measurement. 78

79. (7) CHILD RESISTANCE: These are difficult for young children (under 5 years of age) to open but not difficult for adults to use properly. These have been produced in response to demand for greater protection of children against accidental poisoning. Used for drugs , house cleaning agents, pesticides etc 79

80. DESIGN OF CHILD RESISTANT CLOSURE 80

81. (a) PRESS AND TURN: The cap is removed by applying a downward pressure while the closure is rotated. Click – lock closure is one of the most successful of this type. It also incorporates a form of alarm for an adult in that if the cap is turned without pressing then a clicking sound is heard. 81

82. (b) LIFT AND TURN: It involves applying an upward force while rotating the closure. (c) SQUEEZE AND TURN: Force is applied to the sides of the closure while the screw cap is rotated. 82

83. (4) LINE UP ARROWS AND FLIP: Once the alignment is established the miss- fit between cap and containers is removed and the cap will fit. (5) Pop- lock Closure Can only be operated after a tab on its top has been released and then opening is achieved by pulling on it. 83

84. MATERIALS EMPLOYED FOR FORMATION OF CLOSURES Metals (aluminium, aluminium alloys, tinplate, stainless steel) Rubber (natural & synthetic) Plastic (thermosetting & thermoplastic) Glass (used for formation of stopper) 84

85. METAL: Metal caps are usually coated on the inside with an enamel for resistance against corrosion. Almost all metal crowns and closures are made from electrolytic tinplate, a tin coated steel on which the tin is applied by electrolytic deposition. Tin is most chemically inert. 85

86. PLASTIC: The two basic types of plastic generally used for closure are: Thermosetting Resins: is used for making screw caps for glass and metal containers. The thermosetting plastic first soften under heat and then cures and hardens to a final state. Thermoplastic Resins: Polystyrene , polyethylene and polypropylenes are the materials used in 90% or more of all thermoplastic closures. 86

87. Advantages of Plastic: Flexible and not easily broken Low density and thus light in weight Easily molded in various shapes Cheap Limitations: Not chemically inert Undergo stress cracking and distortion from contact with some chemicals. Not heat sensitive May possess an electrolytic charge and will attract particles.s 87

88. RUBBER: Rubber consist of several ingredients, one of them is elastomer These closure do not pose a problem and can be used in contact with large number of drug preparations. 88

89. TYPES OF RUBBER USED IN PHARMACEUTICALS Butyl rubber (copolymer of isobutylene and isoprene or butadiene) Nitrile rubber (butadiene- acrylonitrile co- polymers) Neoprene rubber Silicon rubber 89

90. Butyl rubber: Cheap, chemical resistant, low water vapour/ air permeability. It is not good for oils. 2) Nitrile rubber: Resistant to oil, heat treatment, vapour absorption but leaching and bactericide absorption is high. 3)Neoprene rubber: - Resistant to heat and oil with low water absorption permeability a compared to natural rubbers. 4)Silicone rubber: - Most heat resistant with very low water absorption and permeability , but costly. 90

91. Types of Rubber Closure 91

92. 1) COMMON FLANGED CLOSURE Most commonly use in closing of vials and bottles. 92

93. (2) SLOTTED OR FREEZE DRIED PRODUCT CLOSURE These closure has a slot or pathway for the ice sublimation Used to seal the freeze dried products or lyophilized products. (3) CARTILAGE AND DISPOSABLE SYRINGE CLOSURE Cartilage is made of glass , one end of which is sealed with the rubber piston and the other end with aluminium over seal and rubber septum. 93

94. CHARACTERISTICS OF IDEAL RUBER CLOSURE It should not be become sticky upon storage It should not become hard on exposure to atmosphere It should not become dark on exposure to air and light Ease in sterilization – rubber closure must with stand heat at least about 120℃ Ease in penetrability and elasticity It must not become sticky during autoclaving It should not allow water vapour and air to pass through it It should be free from leaching and sorption. 94

95. QUALITY CONTRL OF CLOSURE Test for alkalinity Test for rubber closures a. Compatibility with contents b. Permeability to water c. Fragmentation d. Penetrability e. Self saleability f. Quality g. Finish Test 3) Child test 95

96. TEST FOR ALKALINITY Coarsely crush the glass Sieve the crushed glass Take 2 conical flasks, one should be treated as “blank” while other as “sample container” Put the powder in the conical flask and consider as sample container Close both the flask with closure Autoclaved both for prescribed period of time Add NaOH solution to both of container Filter the solution and wash with water Titrate the filtrate with standard normal acid Calculate the normality of alkali and then the concentration is calculated The conc. Of alkali should not exceed the prescribed limit. 96

97. 2. TEST FOR RUBBER CLOSURE (a) Compatibility with other components: All the sterile products are packed aseptically in sterile containers and several are stored under different conditions. At given time intervals up to a year , except for the 50℃ test, which are continued for 3 months only, the samples are examined for- Foreign insoluble matter, using standard conditions of illumination. Loss of potency and preservatives, and increase in toxicity. Signs of deterioration of the closure, such as sponginess and discoloration. The latter should be checked after drying overnight because absorption of water and certain solutes often produces a bleached appearance. 97

98. (b) Permeability to Water- Put calcium chloride in vial and close it with rubber closure and seal it with aluminium seal. Weight the vials Place it for a limited time period Weight again If weight noted down later is more than previous then test fails as weight is increased due to the absorption of water vapour. 98

99. (c) Self sealability test Take a vial and filled it with methylene blue solution Insert needle in to rubber closure 20-25 times with in a circle of 5 nm diameter Vial is inverted in a water in a container to which a prescribed vacuum is applied for half an hour. There must be no signs of leakage in the water or on the closure. 99

100. (d) Fragmentation test for rubber closures (IP 1996) Take 12 clean vials Place a volume of water corresponding to nominal volume minus 4ml in each Close vial with closure and secure caps for 16 hrs. Pierce the closures with hypodermic needle and inject 1 ml water and remove 1ml air 100

101. Repeat the above operation 4 times for each closure Count the number of fragments visible to the naked eye Total number of fragments should not be more than 10 except butyl rubber where the fragment should not exceed 15 101

102. (e ) Penetrability test (by piercing machine) Inverted vial is fitted on clamp and the clamp is allow to move downward at a specified speed. Stand having needle is fitted with piston type cylinder As clamp moves downward with vial, needle will go inside the vial and the position moves downward. Force applied on the vial should not exceed a stated value. 102

103. (F) Quality test: Rubber closure must not be tacky after washing in a detergent, rising several times, autoclaving for half and hour at 121℃ in distilled water and drying for a day at 65℃ in vacuum. (G) Finish Test: They must be substantially free from adventitious dust, fibres, loose particles of rubber, smears of grease and pigment, and quite free from internal foreign matter. 103

104. PACKAGING Packaging is the science , art and technology of enclosing or protecting products for distribution, storage, sale and use. It refers to the process of design, evaluation, and production of packages. Packaging can be described as coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. 104

105. PACKAGING TYPES: Primary Packaging: is the material that first envelops 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. 105

106. Secondary packaging: is outside the primary packaging perhaps used to group primary packages together. 106

107. Tertiary Packaging: is used for bulk handling, Warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly in to containers. 107

108. SECONDARY PACKAGING MATERIAL PAPER: This can be used as a flexible wrap for products, or as a closure material for jars, most paper material are used with a liner applied either as a laminated or as a coating. 108

109. PHARMACEUTICAL CORRUGATED FIBERBOARD Corrugated fibreboard is paper- based construction material consisting of a fluted corrugated sheet and one or two flat linerboard. It is widely used in the manufacture of corrugated boxes. 109

110. CARTON: A carton is a type of suitable for food, Pharmaceuticals, hardware, and many other type of products. Folding cartons and usually combined in to a tube at the manufacturer and shipped flat (Knocked down) to the packager. 110

111. Quality Testing For Secondary Packaging Material DIMENSIONS: The physical dimensions of the given paper board is taken and recorded. GRAMMAGE: A test piece of suitable size (10cm×10cm) is cut and weighed. The grammage of the sample is determined by Grammage = 104×w/ a×b w - weight in grams a – length b- breadth 111

112. THICKNESS : Measured with a micrometre. Thickness is related to grammage of paper and its bulk density. It directly influences the physical property of paper like stiffness, varnishing and cutting . SURFACE PH • Acidity in paper may be caused by the presence of residual chemical left in the pulp. • A drop of distilled water is placed on the top of the test piece and the electrode of pH meter is placed in the drop touching the paper. • The reading is taken after 2 min 112

113. MOISTURE CONTENT : Conditioned specimen is weighed and heated to a constant weight to expel the moisture. The difference of the two weights gives the moisture content of the paper . % moisture = 100(A-B) / B A - Original weight B - Weight after drying ASH CONTENT : Take about 1g of specimen and make it in to shreds and place in a previously weighed crucible (C ). Heat carefully over a burner till completely charred. Transfer the crucible in to a muffle furnace at 8000c until all the carbonaceous matter are burnt off. Cool in desiccator, weigh and repeat the experiment to a constant weight (D ). %Ash= 100(C-D)/D 113

114.   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 114

115. CONCLUSION:  The testing of packaging material is almost requirement for any pharmaceutical industry.  The material for package affect quality, stability, efficacy of drug product.  The cost of material of package should be low as possible without compromising the quality of product .  It should pass the specifications of tests before it reached the local market and made available for the consumers of product. 115

116. REFERENCE: Pharmaceutical product development by N.K. Jain Cooper and Gunn’s “Dispensing for pharmaceutical students ” , CBS Publishers, page no.- 278-345 Modern pharmaceutics by G.S. Banker and C.T. Rhodes Leon Lachman ,“The theory and practice of industrial pharmacy ” , Lea &Febiger,U.S,2nd edition , page no.- 241-306 Remington , “The Science and Practice of Pharmacy”, published by Lippincott Williams & . https ://www.deufol.com [Accessed on Nov 4 ] http://www.authorstream.com/Presentation/v ijaysurender-2834228-quality-control- packaging-materials [Accessed on Nov 4] https ://www.pharmatutor.org/articles/the- pharmaceutical-packaging-article [Accessed on Nov 4] 4. Kennath, Harburn, Quality Control of Packaging Materials in the Pharmaceutical Industry 1st ed. Marcel Dekker.INC, P:135-137 Wilkins , page no. 356-38621 116

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