Pharmaceutical Packaging

Prashik s shimpiDepartment Of QA

RCPIPER

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Content Introduction Of pharmaceutical packaging Types of packaging Container Pharmaceutical packaging Material Glass Plastic Metal Pepar And Card Board Closure Tamper Resistant packaging

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Function Of Packaging

Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use.

Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, convenience ,compliance , integrity and stability of the product .

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Introduction

Protective Function Storage Function Loading and Transport Function Identification Of Product Mechanical Protection Environmental Protection Chemical Protection Biological protection Marketing

Types Of Packaging Primary packaging- is the material that first envelops the

product and hold it. This usually is the smallest unit of distribution or use. Ex. Aerosol spray can, blister packs, bottle

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• Secondary packaging -Is outside the primary packaging perhaps used to group primary package together. Ex. Boxes,cartons

Tertiary packaging- is used to bulk handling warehouse storage and shipping. Ex. Barrel, container,edge protector

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container Pharmaceutical container has been defined as a

device which hold the drug and it may or may not be in direct contact with pharmaceutical preparations.

Charecterestic of container1. It should withstand during normal handling.2. It have pharmaceutically elegant appearance.3. Dose can be drawn from it conveniently.4. It should protect product from enviormental factor.5. Material use in production of container should be

non toxic.6. It should be stable in temperature and pressure

during sterilization in autoclave.7. It should not interact physically and chemically with

product.8. Easily labelled.

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Types Of Container1. Single dose container2. Multi dose container 3. Light resistance container4. Well closed container5. Air tight container6. Tightly closed container7. Tamper evident container8. Aerosol container

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Pharmaceutical packaging material It is use in the production of container by using

following material.1. Glass2. Plastic3. Metal4. Pepar and board Ideal Property Of Packaging Material5. They must protect the preaparation from

enviormental.6. It should not react with product.7. It should not change product taste or odour.8. It shoud be non toxic.9. It should be FDA approved.10. It should produce tamper resistance requirement.

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Glass Glass container commonly used in pharmaceutical

packaging. Advantage:1. Transparent2. Available in various shape and size.3. Stable in temprature and pressure during

sterilisation.4. Economical and readily available5. Protect photosensitive medicament by light6. Impermeable to moisture and atmosperic gases7. Do not deteriorate with age Disadvantages:8. Fragile9. Heavy in weight10. Release alkali

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Composition of glass Sand (silicon dioxide), Soda ash (sodium

carbonate),Limestone (calcium carbonate),Cullet (broken glass) - aluminium, boron, potassium, magnesium, zinc, barium.

Type of glassI. COLOURED GLASS OR AMBER GLASSII. SULPHURED GLASSIII. BOROSILICATE GLASSIV. TREATED SODALIME GLASSV. REGULAR SODALIME GLASSVI. GENERAL PURPOSE SODALIME GLASS

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Amber colour glass: Use for photosensitive product. Obtained by c,s,fe,and magnesium oxide

Sulphur glass: It is obtained by exposing soda lime glass to moist SO2 at

about 500°c to get sulphured glass.

Type I—Highly resistant borosilicate glass. Alkalinity is removed by using boric oxide to neutralized

the oxide of potassium and sodium 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 11

Type II-treated soda lime glass: Type II containers are made of commercial soda

lime glass that has been dealkalized or treated to remove surface alkali

. The de-alkalizing process is know as sulphur 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.

Type III-Regular soda lime glass: It is a soda lime silicate glass with only moderate

hydrolytic resistance. Container form this glass is used for non aquas

parenterals preparation. Ex powder for parenterals use. 12

Type IV-non parenterals genral purpose soda lime glass:

Container made by this glass use for topical or oral preparation.

MANUFACTURE OF GLASS: The four basic processes used in the production of

glass are: Blowing uses compressed air 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.

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Plastic Plastics may be defined as any group of substances, of

natural or synthetic origins, consisting chiefly of polymers of high molecular weight that can be moulded into a shape or from by heat and pressure.

Advantages Less weight than glass, flexible Variety of sizes and shapes Extremely resistant to breakage Transport easily and have mechanical strength Disadvantages Absorption permeable to moisture Poor printing, thermostatic charge.

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TYPES OF PLASTICS Thermosetting type –

When heated they may become flexible but they do not become liquid

e.g. Urea formaldehyde (UF),Phenol formaldehyde ,Melamine formaldehyde (MF), Epoxy resins (epoxides), Polyurethanes (PURs)

Thermoplastics type- On heating they are soften to viscous fluid which harden again on cooling.

e.g. Polyethylene{HDPE – LDPE}, Polyvinylchloride(PVC),Polystyrene Polypropylene, Nylon(PA), Polyethylene terepthalate(PET) ,Polyvinylidene chloride(PVdC), Polycarbonate Acrylonitrile butadiene styrene(ABS)

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MetalsMetals 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.Disadvantages: They are expensive. They react with certain chemicals

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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.

Most commonly used are tin, aluminium and lead.Paper And Board

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•Use in various form of packaging of pharmaceutical products.•Use for preaparing outer container•Ex carton,boxes,envelopes and fiber drums.

Closures Closures are device by means of

container can be opened and closed. Types of closures1. Plug type2. Crown type3. Push fit cap4. Screw closureMaterial for closure making5. Cork6. Glass7. Plastic8. Metal9. Rubber

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TAMPER RESISTANT PACKAGING:

1. Film wrappers2. Blister package3. Strip package4. Shrink seals5. Aerosol containers

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: 1. End folded wrapper2. Fin seal wrapper 3. Shrink wrapper

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1.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.

2.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.

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3.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 .

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2.BLISTER PACKAGE: Blister package provides excellent environmental protection, and

efficacious appearance. 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.

Material use for themoformable blister is PVC, polyethylene combinations , polystyrene and polypropylene.

Material for back cover is polyster or paper.

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3.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.

The strip of packets is cut into desired number of packets.

packaging materials used are: ,polyethylene,PVC.

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4.SHRINK SEAL PACKAGE Shrink wrap, also shrink film, is a material made up

of polymer plastic film. When heat is applied, it shrinks tightly over whatever it is covering after passing through heat tunnel.

 PVC, Polyethylene, Polypropylene .

5.AEROSOL PACKAGING Aerosol is defined as "An Aerosol is a disperse phase

system, in which very fine solid drug particles or liquid droplets get dispersed in the propellants (gas), which acts as continuous phase.

1. Container2. Valve3. Actuator 4. Dip tubePackaging of Aerosol5. Cold fill process6. Pressure fill process 24

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Conclusion: Packaging is very important to protect

the product as well as it maintain the pharmaceutical products stability.

If the attractive packaging has been done then it is beneficial for marketing purpose to improve the sale of product.

ReferencesI. Lachman leon, Lieberman Herbert A., Kanig

Joseph L., “The theory & practice of industrial pharmacy” published by Varghese publishing house, bombay, 3rd edition,1991,page no. 711-732 .

II. D K Tripathi Indudtrial Pharmacy a comprehensive approach,pharmamed press page no. 602 to 664.

III. Mehta R.M., “Pharmaceutics- 1”Published by vallabh prakashan, delhi, 2nd edition, page no . 73-93.

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