Packaging materials of Pharma industry

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PHARMACEUTICAL PACKAGING MATERIALS By Pynda sindhuka:

PHARMACEUTICAL PACKAGING MATERIALS By Pynda sindhuka 1

Introduction::

Introduction: Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, containment, convenience ,compliance , integrity and stability of the product . The selection of a package therefore begins with a determination of the product’s physical and chemical characteristics, its protective needs, and its marketing requirements. 2

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The materials selected must have following characteristics: They must protect the preparation from environmental conditions . They must not be reactive with the product. They must not impart to the product tastes or odors. Must be non toxic . They must be “FDA” approved. They must meet applicable tamper – resistance requirements. They must be adaptable to commonly employed high-speed packaging equipment 3

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Types of containers: Containers are divided into following types on the basis of their utility : Well closed containers Single dose containers Multi dose containers Light resistant containers Air tight containers Aerosol containers Well – closed containers : A well-closed container protects the contents from loss during transportation,handling,storage or sale. Single dose containers : These containers are used to supply only one single dose of medicament and generally used for parenteral products. E.g. ampoules and vials 4

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Multi dose containers : 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 injectables. E.g. vials 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. 5

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Air-tight containers : These are also called hermetic containers. These containers have air-tight sealing or closing. These containers protect the products from dust, moisture and air. Where as air-tight sealed containers are used for injectables,air-tight closed containers are meant for the storage of other products. 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. 6

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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

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Secondary packaging Is outside the primary packaging-perhaps used to group primary packages together. 8

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Tertiary packages: I s 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

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QUALITIES 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 . It should be made of materials which can withstand wear and tear during normal handling. It should be able to withstand changes in pressure and temperature. The materials used for making of the container must be non-toxic. 10

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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. 11

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RUBBER - e.g. closures, caps,vialswrapers,plungers. Metals - e.g . collapsabletubes,foils,needles,aerosol containers 12

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Paper or cardboard - e.g . secondary packaging labels,inserts,displayunits,pouches,laminates,cartons,carrogated boxes,foils,paper drums 13

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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: 14

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Manufacture of glass: The four basic processes used in the production of glass are:- Blowing uses compressed air to form the molten glass in the cavity of metal mold. In drawing , molten glass is pulled through dies or rollers that shape the soft glass. In pressing mechanical force is used to press the molten glass against the side of a mold. Casting uses gravity or centrifugal force to cause molten glass to form in the cavity of mold. 15

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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. 16

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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. 17

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Type-III regular soda lime glass Containers are untreated are made of commercial soda lime glass of average are better than average chemical resistanc e. 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. 18

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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. 19

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Test Method Glass type Over flow capacity O.O2 M H 2 SO 4 required (ml) Powdered Glass test Type I All 1 Water attack test Type II ≤ 100 > 100 0.7 0.2 Powdered Glass test Type III All 8.5 Powdered Glass test Type IV /NP All 15 STANDARDS: 20

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ADVANTAGES OF GLASS: They are quite strong and rigid. They are transparent which allows visual inspection of the contents. They are available in various shapes and sizes. They can withstand the variation in temperature and pressure during sterilization. They are economical and readily available. They (Amber colored glass) can protect the photosensitive medicaments from light during their storage. They do not deteriorate with age. 21

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DISADVANTAGES OF GLASS : They are brittle and break easily. They may crack when subject to sudden changes in temperatures. They are heavier in comparison to plastic containers. 22

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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 . 23

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PLASTIC ARE OF TWO FROMS : Amorphous plastic. 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. 24

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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. 25

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Plastic containers for pharmaceutical products are primarily made from the following polymers: polyethylene polypropylene poly vinyl chloride polystyrene polymethyl methacrylate amino formaldehyde poly amides 26

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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: 27

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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 110 0 to 150 0 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. 28

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POLYVINYL CHLORIDE (PVC ): It is less flexible , heavier and more permeable to water vapour as compared with normal polythene.it has high clarity and not effected by sunlight. It is used for preparing eye ointment tubes. 29

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POLYMETYL METACARYLATE(PMMA): It is hard , strong but light, transparent plastic. It softens at about100 0 c. It is used for preparing bottles and tubes. 30

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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. 31

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POLYPROPYLENE: It is similar to high density polythene. It is very light and heat resistant. Its melting point is 170 0 c It has high melting point and can sterilized by autoclaving. So it is used for preparing squeeze bottles, tubes, and syringes. 32

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POLYCARBONATE: It is transparent, has high impact strength and very good heat resistance. It is used in the preparation of surgical equipment. 33

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ADVANTAGES OF PLASTIC: They are light in weight and can be handled easily. They are transported easily. They are unbreakable. They available in various shapes and sizes. They are resistant to inorganic chemicals. 34

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DISAVANTAGES OF PLASTIC: They are permeable to water vapour and atmospheric gases. They are poor conductor to heat. They may absorb chemical substances, such as preservative for solutions. They are relatively expensive. 35

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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: Permeation Leaching Sorption Chemical reaction Alteration 36

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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. 37

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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 . 38

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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… 39

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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 . 40

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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. 41

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METALS: Metals are used for construction of containers. The metals commonly used for this purpose are aluminium ,tin plated steel, stainless steel, tin and lead. ADVANTAGES: They are impermeable to light, moisture and gases. They are made into rigid unbreakable containers by impact extrusion. They are light in weight compared to glass containers. Labels can printed directly on to their surface. 42

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DISADVANTAGES: They are expensive. They react with certain chemicals. 43

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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 . 44

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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 . 45

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Aluminum: Aluminum tubes offer significant savings in product shipping costs because of their light weight . They are attractive in nature . 46

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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. 47

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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 Screw on, threaded or lug Crimp on(crowns) Press on(snap) Roll on and Friction 48

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Threaded screw cap: When a screw cap is applied, its threads engaged with the corresponding threads molded on the neck of the bottle. A liner in the cap, pressed against the opening of the container, seals the product in the container and provide the resistance to chemical and physical reaction with the product. 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. 49

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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. 50

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Crown caps: This style cap is commonly used as a crimped closure for beverage bottles. 51

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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. 52

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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. 53

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CLOSURE LINERS: A liner may be defined as any material that inserted in a cap to effect a seal between the closure and the container. It is of two types: Homogeneous liner These are one piece liners available as disk or a ring of rubber or plastic. It can be withstand high temperature sterilization. Heterogeneous liners These are composed of layers of different materials chosen for specific requirements. It consists of facing and backing. Facing is in contact with product and backing provides questioning effect. 54

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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 130 0 C. Oil and solvent resistance is not very good. 55

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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. 56

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SILICON RUBBERS: Advantages: Heat resistance. Extremely low absorption and permeability of water. Excellent aging characteristic. Disadvantages: They are very expensive. 57

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TAMPER RESISTANT PACKAGING: The requirement for tamper resistant packaging is now one of the major considerations in the development of packaging for pharmaceutical products. Tamper resistant package is one having an indicator to entry in which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. 58

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FDA approves the following configurations as tamper resistant packaging: Film wrappers Blister package Strip package Bubble pack Shrink seals and bands Oil, paper, plastic pouches Bottle seals Tape seals Breakable caps Aerosol containers 59

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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: End folded wrapper Fin seal wrapper Shrink wrapp er 60

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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. 61

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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. 62

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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 . 63

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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 64

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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. 65

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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. 66

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The strip of packets is cut into desired number of packets. Different packaging materials used are: paper/polyethylene/foil/PVC. 67

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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. 68

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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. 69

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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 . Typically glassine liners are two ply laminations use in two sheet of glassine paper bounded together with wax or adhesive. For pressure sensitive inner seals pressure sensitive adhesive is coated on the surface of the inner seal as an encapsulated adhesive. 70

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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. The paper used must often is a high density light weight paper with poor tear strength. Labels made of self destructing papers are available . But these cannot survive any attempt at removal once they have been applied. 71

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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. The bottom portion of the closure has a tear away strip. 72

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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. 73

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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. 74

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The spray nozzles are usually metered to allow a specific dose to be dispensed with each spray. 75

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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. 76

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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 77

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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 78

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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 140 o c Transfer to weighing bottle and cool in a desiccator Final specimen should be used in powdered glass test 79

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POWDERED GL ASS TEST: ( according to USP volume 27) Transfer 10gms of prepared specimen in a 250ml conical flask digested previously with high purity water in a bath at 90 o c Add to conical flask containing 50ml high purity water Cap all the flasks and auto clave Adjust temperature to 150 o c Cold the temperature to 121 o c for 30mins Cool the flasks under running water 80

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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 81

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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 82

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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 83

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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% 84

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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 10 85

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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 86

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