TYPES AND CLASSIFICATION OF PACKAGING

A.P.M.C. Collage Of Pharmaceutical Education And Research, Motipura , Himmatnagar.

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1.Introduction to the packaging 2.Types 3.Packaging materials (a) Glass (b) Plastic (c) Metals (d) Paper and Board (e) Rubber (f) Films & foils 4.Special category of container 5.Closures 6.Others (a) Cotton (b) Inks 7.Examples 8.Instruments used in packaging 9.References
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Packing: Packing consists of enclosing an individual item, or several items, in a container, usually for shipment or delivery. This operation is mostly done by hand and machine.

Pharmaceutical Packaging: Pharmaceutical packaging means the combination of components necessary to contain, preserve, protect & deliver a safe, efficacious drug product.
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PRIMARY PACKAGING SECONDARY PACKAGING

TERTIARY PACKAGING

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Table 1: Examples of types of packaging Primary Glass bottles, jars Plastic bottles Strip packs Blister packs Pouches Ointment tubes Vials, ampoules Pre-filled syringes Aerosol containers Pre-filled inhalers Paperboard containers Wrappers
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Secondary Cartons Prescription dispensing containers Corrugated boxes Paper drums Shipping containers Injection trays

Tertiary Barrel Container Intermediate bulk container Slip sheet Crate Edge protector Pallets Stretch wrap

WELL CLOSED CONTAINER: It protects the contents from extraneous solid and from loss of the article under the ordinary condition. 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 . LIGHT RESISTANT CONTAINER: It protects the contents from the effect of light. 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.
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(a) Glass (b) Plastic (c) Metals (d) Paper and Board (e) Rubber (f) Films & foils

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Solid medicine bottles

Liquid medicine bottles

Cartridges-Tubes

Cosmetic bottles

Tubular glass vials

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Aluminum combined bottles Clear glass bottles DHAVAL PATEL ROLL NO:05

 Composition

of glass

p Mainly made up of Sand pure silica Soda-ash sodium carbonate Limestone calcium carbonate
CATIONS:

silicone, aluminum, boron, sodium, potassium, calcium, magnesium, zinc & barium. ANION: oxygen.

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Table2: Types of the glass Type I Type II Type III Borosilicate Glass Treated Soda-Lime Glass Regular Soda-Lime Glass

Type NP

General Purpose SodaLime Glass

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 Highly

resistant glass. A substantial part of the alkali & earth cations are replaced by boron and/or aluminum & zinc. More chemically inert than the soda-lime glass Used to contain strong acids & alkalies. Addition of approx 6% boron to form type I glass reduces the leaching action.

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Table3: Comparison of type I and type III Distilled water stored for 1 year in Type III 10-15 ppm NaOH Type I 0.5 ppm NaOH

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 BLOOMING

or WEATHERING & it gives the appearance of fine crystals on the glass. II containers are made of commercial soda-lime glass that has been de-alkalized or treated to remove surface alkali. TREATMENT and virtually prevents weathering of empty bottles.

Type

SULFUR

It

neutralizes the alkaline oxides on the surface & rendering the glass more chemically resistant.
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 Containers

are untreated.

Made

up of commercial soda-lime glass of average or better-than-average chemical resistance.

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 Containers

made up of soda-lime glass are supplied for non-parenteral products intended for oral or topical use.

those

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Table 4 PACKAGE TYPE TYPE OF FORMULATION CAN BE PACKED Aqueous Injectables Of Any pH Ampoule Aqueous Injectables Of pH Less Than 7 Non-Aqueous Injectables Aqueous Injectables Of Any pH Aqueous Injectables Of pH Less Than 7 Vial Non-Aqueous Injectables Dry Powders For Parenteral Use (Need To Be Reconstituted Before Use) GLASS USED Type I Type II Type III Type I Type II Type III Type IV

Tablets, Capsules, Oral Solids & Other Solids For Reconstitution Bottles and Jars Oral Liquids (Solutions, Suspensions, Emulsions) Nasal & Ear Drops Certain Types Of External Semisolids (Rubeficients, Local Irritants) Blood & Related Products Dropper Aerosol
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Type IV Type IV Type IV Type IV Type I Type IV Type I

Auxiliary Packaging Device With Certain Kind Of Products Aerosol product ( solution, suspension, emulsion or semisolid type)
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 Advantages:

Superior protective qualities Economical Readily available in a wide variety of sizes & shapes Chemically inert, impermeable, strong and rigid FDA clearance Does not deteriorate with age Provides an excellent barrier against every element except light. Colored glass, especially amber, can give protection against light.

Disadvantages:

Fragility Heavy Weight.

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Table 5: Polymers used for the production of Plastics COMMONLY USED POLYMERS Polyethylene Polypropylene Polyvinyl chloride (PVC) Polystyrene Polyamides LESS COMMONLY USED POLYMERS Polymethyl methacrylate Polyethylene terephthalate Polytrifluoroethylene Aminoformaldehydes

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 Dosage

Form Plastic Interactions / Limitations of Plastic Materials:

Permeation Leaching Sorption Chemical modification Alteration on the properties of plastics or product

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Table 6: comparison of polymer

. Properties Low Density Clarity Hazy, Translucent Water Absorption +, ++ + +, ++ Polyethylene High Propylene Density Hazy, Translucent Clear Clear Clear Clear Clear . Poly PVC Styrene Polymer Poly MultiPolymer Acrylic Nitrile

Permeability To Water Vapor Oxygen CO2 Resistance To Acids Alcohol Alkalis Mineral Oil +, +++ ++ ++ +, +++ ++ ++
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++ ++

+, ++ +, ++

+, ++ +, ++

+ -

++ ++ ++

++ +

+ ---

+, +++ ++ +++
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+++ +++ ++ ++

+, ++ ++ +

-, ++ + -, ++
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-, ++ + ++ +++

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++

Heat Cold Sunlight High Humidity Stiffness Cost

++++ + ++++ Low

+ ++++ + ++++ + Low Detergents Bleaches Milk

++ -, + + ++++ +, ++ Low

+, -++ ++++ +, ++ Mod Shampoos Oils Detergents

+ +, ++++ +, ++ Low

++ ++ + +, ++ Mod

+ ++ ++++ +, ++ High

Foods Drugs Dry Drugs Petroleum Jellies Foods Drugs Cosmetics Cosmetics Chemicals Aerosols Carbonate d

Cosmetics Typical Uses Personal

Drugs Foods Cosmetics Industrial Wine Syrups Cleansing Floor Juices Powders Drugs Cosmetics Waxes Vinegar Salad Oil Whisky

Products Foods

Beverages

Signs: [- - : very poor, very low] [- : poor, low] [+: fair, moderate] [++: good, high] [+++: very good] [++++: excellent]
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 Advantages:

Ease of manufacturing Available in various types of quality Freedom of design to which they lend

themselves

Extremely resistant to breakage

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 Strong,

unbreakable to high and low temperature.

Resistant

Due

to their chemical reactivity, metals require the application of coating for closures

Used

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 Source:

bauxite ore. excellent corrosion resistance due to the thin surface layer of aluminium oxide. good thermal and electrical conductor. capable of being superconductor.
Precaution:

Aluminium is neurotoxin that cause Alzheimers disease. Allergic reaction, vomiting and other symptoms of poisoning are occur.

the

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 It

is the aluminium prepared in thin sheets. Can be bent or wrapped around objects. Known as al-foil or alu-foil and tin-foil, silver paper, Reynolds wrap. Gives slight tin taste to food wrapped in it. Used for packaging of tablets and capsules. Excellent barrier for moisture, gas and light. Suitable for blister packs and strip packs. Aluminium foil laminated with paper or plastic is used as heat sealed membrane.
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BLISTER PACKS
plastic base web blister formed with aid of heating low to high barrier Lidding Foil typically 20 micron Al

Film - eg PVC, PVC/PVDC, PVDC.

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COLD FORM BLISTER

 

blister formed mechanically (no heat) high barrier

Lidding Foil

Foil Laminate e.g. PVP/foil/PVC, or OPA/foil

- PVP Film - Primer/Adhesive - Aluminium foil - Primer/Adhesive

- PVC (may be PP)

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is malleable, ductile, highly crystalline, silvery white metal. Resists corrosion from distilled, seal and soft tap water, but can be attacked by strong acids, alkalis, and by acid salts. Highly polished tin is used as protective coat for other metals. It combines directly with chlorine and oxygen and displaces hydrogen from dilute acids. Replaced in early 20th century by the use of aluminum foil.
Tin
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 It

has dull luster and is dense, ductile, very soft, highly malleable, bluish white metal that has poor electrical conductivity. This metal is highly resistant to corrosion Used to contain corrosive liquid (sulfuric acid). It can be toughened by adding a small amount of antimony or other metals. It is very poisonous. It reduces the transmission of radiation.

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 It

is container that permits controlled amount to be dispensed easily, with good reclosure, and adequate protection of the product. Risk of the contamination is minimal. Tin, aluminum and lead are used. Aluminum tubes save shipping costs because of their light weight. Provide attractiveness of tin at lower cost. Lead has lowest cost of all the tubes. Wax linings are most often used with water based products in tin tubes, and phenolics, epoxides, and vinyls.
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Table 6: Package type and the formulation and remarks

PACKAGE FORMULATION TYPE Polymer coated aluminum with various thickness are available to improve the Strip, blister Tablets, capsules sealability of the pack and stability of the product. The tubes with internal protective coating Ointments, creams, gels & Collapsible tubes other semisolids available. of polymers with spike & without spike are REMARKS

Pressure resistant and internal polymer Cans Aerosols, inhalers, sprays etc. coated aluminum containers are available.

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 Paper-based

materials include: Labels, Cartons, Bags, Outers, Trays For Shrink Wraps, Layer Boards On Pallets, etc. as well as Advantages of Cartons

Applications

Increases display area Assembles leaflets Provides physical protection Fiberboard outers used for bulk shipments.

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 Corrugated

fiberboard is a paper-based material consisting of a fluted corrugated sheet. Used in the manufacture of corrugated boxes. Double and triple-wall corrugated board is also produced for high stacking strength and puncture resistance.

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 Boxes

can be formed in the same plant as the corrugators. Alternatively, sheets of corrugated board may be sent to a different manufacturing facility for box fabrication. Bending of the board. Most often, slots are cut to provide flaps on the box. Scoring and slotting can also be accomplished by diecutting.
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 Carton

is the name of certain types of containers typically made from paperboard which is also sometimes known as "cardboard. Many types of cartons are used in packaging. cartons are usually combined into a tube at the manufacturer and shipped flat to the packager. Tray styles have a solid bottom and are often shipped as flat blanks and assembled by the packager.
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Folding

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 Regenerated

cellulose film, cellulose coatings, foil and paper play different roles such as supportive, barrier, heat seal & decorative. Aluminum foil in the thinnest gauges offers the best barrier properties, which are not given by the most impermeable plastics. Metallization: A relatively new process whereby particles of metal are laid down onto a surface under vacuum, can improve the barrier properties of a material. In Co-Extrusion,a number of plastic plies are extruded in combination to produce cheaper laminations.

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Mostly used to make stoppers and bulbs for dropper assemblies. Examples of rubber for pharmaceutical products include: Natural rubber Neoprene rubber Nitrile rubber Butyl rubber Chlorobutyl rubber Bromobutyl rubber Silicone rubber
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(a) Child resistant container

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 5 minutes of receiving it packaging which is resistant to opening by children (under 52 months old), but which does not pose difficulties for the elderly (over 65 years) to open and to re-close properly.

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Resist the tampering of the product before consumer the product. They help in. Receiving the products by patients as manufactured Tamper proof containers

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 Plastic Blind-end Heat Sealed Tubes Cans In-Built Tamper-Evident Controls
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 Depending

upon container, closures have different shapes & sizes. design of stopper may also be required for some pharmaceutical production processes such as lyophilization. are part of the primary packaging

Special

Closures

system.

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Screw caps:In metal or plastic, preheated or rolled on with or without a wadding system (i.e. wadless). Wad is a mass of soft material used to stop hole.

Plug in A friction push in fit These have good barrier properties and are reasonably inert, and most widely used these days.

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Rolled On (RO) Or Rolled On Pilfer Proof (ROPP) aluminum alloy metal caps are popular for security of export products. RO and ROPP closure consists of a plain metal shell containing wadding or flowed-in system, which is placed over the container neck & pressure is applied on top to give a good impression on the wad. In case of pilfer proof closure; an additional perforated collar is ruled under a lower bead. This is capable of maintaining an excellent seal

Rolled On

Pilfer Proof

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Pull-Ring-Aluminium Caps
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(a)Cotton: Package types and remarks are enumerated in table 7

Package type

Remarks in solid preparations to prevent the collision of individual units or to absorb moisture etc. to prevent absorption of moisture particularly by tablets & capsules from environment.
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wadding

as desiccant

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(b) Inks
They

are not water-based emulsions and usually dissolved in toluene, alcohol.

should be performed to determine whether components migrate in to the container Testing should be conducted on the effectiveness of the adhesive under appropriate challenge conditions (e.g., temperature and humidity).
Testing If

direct label imprinting is done on containers then resistant ink be used.

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DOSAGE FORM

CONDITION

ROUTE OF DELIVERY

POSSIBLE PACKAGE FORM Glass Or Plastic Bottle And Cap Blister And Strip Packaging Sachet, Pouches Drums And Jars

MANUFACTU RED BY

Solids (Tablets, Capsules, Powders)

Non-Sterile

Oral

Zandu pharmaceutica ls Cadila pharmaceutica ls Eli Lilly and Company Hebei Jiheng(Group) Pharmaceutica l Co., Ltd. Glenmark pharmaceutic als AstraZeneca Canada Inc.
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Solids

Non-Sterile

Rectal Suppository Inhalation

Foil Pouch Or Blister DryPowder Inhaler

Solids

Aseptic

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In blister

In glass bottle

In sachet

In plastic bottle

Dry-Powder Inhaler

In jar
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In strip
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Liquids

Non-Sterile

Oral

Glass Or Plastic Bottle And Cap Bottle With Spray Pump Bottle With Dropper Assembly Sachet, Pouches Drums And Jars

Alembic chemicals Shenzhen Bona Medicinal Packaging Mateiral Co., Ltd Trameel Products

Liquids

Non-Sterile

Topical

Liquids Sterile Parenteral, Ophthalmic -

Glass Or Plastic Bottle And Cap Over Dropper Tip Collapsible Tube Aerosol Sprays Drums And Jars Glass Ampoules Glass Or Plastic Vial With Stopper Glass Or Plastic Vials With Applicators Pre-Filled Syringe Bag Pre-Filled Form-FillSeal Plastic Container

KAYVEE AEROPHARM PVT. LTD. Piramal Healthcare Limited AEROMAC (INDIA) INC. Claris Lifesciences Limited Star Drugs & Research Labs Ltd. Reyoung Pharmaceutical Co., Ltd. IL YANG PHARM,CO. Srinton Pharmaceuticals

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Aerosol Sprays

In Bottle With Spray Pump

In jar

In Bottle With Dropper Assembly

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In plastic bottle

In Collapsible Tube

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Ointments, Creams

Non-Sterile

Topical

Collapsible Tube Pump (High Viscosity Dispenser) Transderma l Delivery Device Glass Of Plastic Jar

Neiss Labs Pvt. Ltd. GALENTIC PHARMA ( INDIA ) PVT. LTD. DOLLAR COMPANY PVT LTD B- TEX OINTMENT & LOTION GALENTIC PHARMA (INDIA) private limited. Kim Chemicals Ltd. Halo Pharmaceutical s

Ointments

Sterile

Ophthalmic

Collapsible Tube Glass Or Plastic Bottle And Cap Form-FillSeal Plastic Bottle Glass Of Plastic Jar Soft Gelatin Capsules

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In Transdermal Delivery Device

In Soft Gelatin Capsules

In Collapsible Tube

In Pump (High Viscosity Dispenser)

In Glass and Plastic Jar

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I. Solid dosage form 1. Vertical blister pack cartoner 2. Carousel blister packaging machines 3. Blister packer with printer

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Cartoning machine for blister CV4 200C vertical cartoner will pack blister packs into a new flip-top-style carton

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It automatically feeds up to five components and is suited for unit-dose blister cards, sustainable trapped-style packaging. dual-position sealing platen increases dwell time at all speeds
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Thermal-transfer printer packages solids, liquids, and powders into unit doses and prints fixed and variable text and graphics on blister packs For OTC and regulated pharmaceuticals and nutraceuticals, the integrated tabletop system maximizes production flexibility and minimizes equipment costs
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 II.

Liquid dosage form nozzle for liquid filler

Controlled

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 III.

Semisolid dosage form pouch sealer/cutter

Medical

CeraTek

12-MPK/2

and

24-

MPK/2 allow medical device manufacturers to combine

medical pouch sealing and cutting in one step following sterilization

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Robotic multi-SKU packaging system

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Robotic case packer

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Rotary tower stretch wrapper

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Robotic feeding system

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Marking and verification system

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Auto blister packaging machine

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1. Pharmaceutical packaging technology, by U.K. Jain, D.C. Goupale, S. nayak. 2.USP 24, NF 19, 2000 3.The theory & Practice of Industrial Pharmacy by Leon Lachman, Third edition, 4.Plastic Packaging , Remington: The Science and Practice of Pharmacy, 19th edition, Volume I 5.http://www.healthcarepackaging.com/mach ines.php 6.http://www.china-pharmaceuticalmachine.com/
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