PHARMACEUTICAL PACKAGING AND MATERIALS FOR

CONSTRUCTION OF PHARMACEUTICAL

EQUIPMENT

Under the guidance of

Dr.R.SANTOSH KUMAR M.Pharm,Ph.D.

CH.DIVAKAR RAOM.PHARM (Pharmaceutical Technology)

Dept. of Pharmaceutical TechnologyRegd. No.: 610233701005

SRINIVASA RAO COLLEGE OF PHARMACY

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.

o 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.

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

Types of containers:Containers are divided into following types on the basis of their utility :

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 of medicament and hold generally parenteral products.

E.g. ampoules and vials

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.

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.

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 :

Secondary packaging

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

Tertiary packages:

Is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container.

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.

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.

RUBBER- e.g. closures, caps,vialswrapers,plungers.

Metals-e.g. collapsabletubes,foils,needles,aerosol containers

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

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:

Manufacture of glass:

The four basic processes used in the production of glass are:-1. Blowing uses compressed air to form the molten glass in the cavity of

metal mold.

2. In drawing, molten glass is pulled through dies or rollers that shape the soft glass.

3. In pressing mechanical force is used to press the molten glass against the side of a mold.

4. Casting uses gravity or centrifugal force to cause molten glass to form in the cavity of mold.

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.

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.

Type-III regular soda lime glass

Containers are untreated are made of commercial soda lime glass of

average are better than average chemical resistance.

It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances.

Flakes separate easily.

USES:For all solid dosage forms.For oily injections.

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.

Test Method Glass type Over flow capacity

O.O 2 M H2SO4

required (ml)

Powdered Glass test

Type I All 1

Water attack test

Type II ≤ 100> 100

0.70.2

Powdered Glass test

Type III All 8.5

Powdered Glass test

Type IV /NP All 15

STANDARDS:

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 can protect the photosensitive medicaments from light during their storage.

They do not deteriorate with age.

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.

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.

PLASTIC ARE OF TWO FROMS:

1. Amorphous plastic.

2. Crystalline plastic.

AMORPHOUS PLASTIC:

They give good transparency.

They are hard but posses little brittleness.

They are more permeable to gases and vapour.

They are of less inert.

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.

Plastic containers for pharmaceutical products are primarily made from the following polymers: polyethylene

polypropylene

poly vinyl chloride polystyrene

polymethyl methacrylate

amino formaldehyde

poly amides

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:

1) Polyethylene:

Its is flexible, very light but tough plastic.

It is impermeable to water vapour and does not deteriorate with age unless it is exposed to sunlight for long time.

It has permeability to certain oils and preservatives.

Its melting point being in the range of 1100 to 1500c

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.

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.

POLYMETYL METOCARYLATE(PMMA):

It is hard , strong but light, transparent plastic.

It softens at about1000c.

It is used for preparing bottles and tubes.

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.

POLYPROPYLENE:

It is similar to high density polythene.

It is very light and heat resistant.

Its melting point is 1700cIt has high melting point and can sterilized by autoclaving.

So it is used for preparing squeeze bottles, tubes, and syringes.

POLYCARBONATE:

It is transparent, has high impact strength and very good heat resistance.

It is used in the preparation of surgical equipment.

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.

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.

DRUG-PLASTIC CONSIDERATIONS

A packaging system must protect the drug without altering the composition of the product until the last dose is removed.

Drug-plastic considerations have been divided into five categories:

1. Permeation

2. Leaching

3. Sorption

4. Chemical reaction

5. Alteration

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.

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.

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…

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.

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.

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.

DISADVANTAGES:

They are expensive.

They react with certain chemicals.

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.

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.

Aluminum:

Aluminum tubes offer significant savings in product shipping costs because of their light weight.

They are attractive in nature.

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.

CLOSURE:

A closure is the part of the package which prevent the contents from escaping and allow no substance to enter the container.

Closures are available in five basic designs 1. Screw on, threaded or lug2. Crimp on(crowns)3. Press on(snap)4. Roll on and5. Friction

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.

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.

Crown caps:

This style cap is commonly used as a crimped closure for beverage bottles.

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.

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.

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:

1. Homogeneous liner

These are one piece liners available as disk or a ring of rubber or plastic.

It can be withstand high temperature sterilization.

2. 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.

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 1300C.Oil and solvent resistance is not very good.

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.

SILICON RUBBERS:

Advantages:

Heat resistance.Extremely low absorption and permeability of water.Excellent aging characteristic.

Disadvantages:

They are very expensive.

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.

FDA approves the following configurations as tamper resistant packaging:

1. Film wrappers2. Blister package3. Strip package4. Bubble pack5. Shrink seals and bands6. Oil, paper, plastic pouches7. Bottle seals8. Tape seals9. Breakable caps10. Aerosol containers

1. Film wrapperFilm wrapping has been used extensively over the years for products requiring package integrity or environmental protection.

It is categorizes into following types:

i. End folded wrapper

ii. Fin seal wrapper

iii. Shrink wrapper

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.

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.

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.

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

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.

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.

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

Different packaging materials used are:

paper/polyethylene/foil/PVC.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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

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 140oc

Transfer to weighing bottle and cool in a desiccator

Final specimen should be used in powdered glass test

1) POWDERED GLASS 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 90o c

Add to conical flask containing 50ml high purity water

Cap all the flasks and auto clave

Adjust temperature to 150oc

Cold the temperature to 121oc for 30mins

Cool the flasks under running water

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

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

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

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%

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

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

MATERIALS FOR CONSTRUCTION OF PHARMACEUTICAL EQUIPMENT

FACTORS AFFECTING SELECTION OF MATERIALS FOR PLANT CONSTRUCTION

3 Types of factors:

I. Chemical factors.

II. Physical factors.

III. Economical factors.

CHEMICAL FACTORS:

1. Contamination of the product by material of plant lead to instability, decomposition and physiological effect.

E.g. presence of traces of heavy metal decompose penicillin.

Stability of vitamins decrease in presence of metallic ions.

The color of esters will change to pale yellow in the presence of iron impurities.

Esters should be processed in stainless steel.

2 .The effect on the material of plant by drugs and chemicals.

Acids, Alkali and Oxidizing agent and tannins may affect the material of construction.

Allows and Plastic have a corrosion resistant properties.

PHYSICAL FACTORS:

Adequate mechanical strength.Erosion.Weight.Ease of fabrication.Thermal expansion.Thermal conductivity.Cleansing.Sterilization.Transparency.

• The material should have sufficient strength so that it can withstand the stress to which the material is subjected in the production.

• Iron and Steel satisfy this property.• E.g. The packing material should

withstand the rigors of handling and transportation.

• The equipment should have a light weight so it is easy to transport.

• Plastic materials employed for the manufacture of container for the use of pharmaceuticals and cosmetics because of its light weight.

STRENGTH

MASS

WEAR PROPERTIES

• There is a possibility of friction between the moving parts.

• During milling and grinding surface wear off and this materials will be incorporated into powder as impurities.

THERMAL CONDUCTIVTY

• The materials used for evaporators ,dryers and heat exchanger should have a good thermal conductivity.

• Resistant film retard the rate of heat transfer.

THERMAL EXPANSION

• If the materials has high coefficient of expansion, the temperature changes cause increase in stress and risk of fracture.

• The materials should be able to maintain size and shape of equipment at working temperature.

TRANSPENCY

• It permits the visual observation of the changes during a process.

• For this reason borosilicate glass has been used in the construction of reactors,fermentors etc.

ECONOMIC FACTORS

• Initial costs and maintenance of the plant must be economical.

• Low wearing qualities and lower maintenance.

• Higher initial cost is more economical in the long run.

EASE OF FABRICATION

• During fabrication, the materials under go various processes such as casting,welding,forging etc.

• Glass and plastic can be easily molded into containers of different size and shape.

CLEANSING

• Smooth and polished surfaces allow the process of cleansing easy.

• Stainless steel and glass are easy for cleansing.

STERILIZATION

• In the production of parenterals, ophthalmic products, antibiotics and biological, sterilization is an essential step which is obtained by autoclaving.

• The material should be able to withstand the steam pressure.

MATERIAL OF CONSTRUCTION

METALSNON-

METALS

FERROURSNON-

FERROUSIN -

ORGANIC ORGANIC

GLASS RUBBER

PLASTICS

ALUMINIUM

LEAD

CAST IRONSTEEL

CARBON

STAINLESSTEEL

FERROUS METALS:

oWidely used because of its mechanical strength, abundant availability and lower cost.

Carbon steel.

FERROUS METALS

CAST IRON

Carbon steel.

Stainless steel

CAST IRON:

Cast iron consist of iron with a proportion of carbon.

The properties of iron depends on the amount of carbon present.

They are hard and brittle.

Cast iron is abundantly available inexpensive.

• Cheap.• Resistant to conc. Sulphuric acid, nitric

acid and dilute alkalis.• It has low thermal conductivity so used

for construction of outer jackets of steam parts.

ADVANTAGES

• It is very brittle so difficult to machine.• It is attacked by dil. Sulphuric acid,

nitric acid as well as conc. hydro chloric acid.

• It has low thermal conductivity so not used for heat transfer in steel.

DISADVANTAGES

• Supports for plant.• Jacket of steam pans.• Lining with enamel, plastic or suitable

protective materials.

USES

CARBON STEEL OR MILD STEEL: Carbon steel is an iron alloy, which contains only a small percentage of carbon.

•Cheapest.• Used in fabrication.ADVANTAGES

• Carbon steel has limited resistant to corrision.It can be improved by preparing alloys.

• Its reacts with caustic soda, brine and sea water.

DISADVANTAGES

• Used in construction of bars, pipes and plates.

• Used to fabricate large storage tanks for water and organic solvents.

USES

STAINLESS STEEL:

Steels containing 18 % of chromium and 8% of nickel and known as “18/8 Stainless steel” , have considerable use in the pharmaceutical industry.

Chromium and nickel, which makes the steel corrosion resistant.

Stainless steel is stabilized by the addition of titanium, or tantalum.

Minor amount of other elements such as copper, molybdenum and selenium are added.

PROPERTIES OF STAINLESS STEEL:

Heat resistant.

Corrosion resistant.

Ease of fabrication.

Tensile strength.

Cleaning and sterilization.

• Corrosion resistant• Heat resistant.• Ease of fabrication.

ADVANTAGES

• Ductility is poor.• Not good against reducing agents.DISADVANTAGES

• Sinks, bench tops, storage tanks, buckets etc.

USES

NON-FERROUS METALS

ALUMINIUM

LEAD

ALUMINIUM:

Its is cheap, light in weight and offer good mechanical strength.

Aluminum equipment can be easily fabricated.

Aluminum can be strengthened by cold working.

Number of modification of aluminum are available.

Aluminum is non toxic to micro-organism.

• High resistant to atmosphere conditions,industrial fumes,vapour and fresh or salt waters.

• Thermal conductivity of aluminum is 60% that of pure copper.

ADVANTAGES

• Mechanical strength decrease above 1500c.

• Aluminum can not be used with strong caustic solution.

DISADVANTAGES

• Used in heat transfer.• Used as storage containers.USES

LEAD:

It has the lowest cost.

Used as collapsible tube material particularly for non-food products such as adhesive inks, paints and lubricants.

Lead tubes with internal linings are used for fluoride tooth-paste.

Lead chamber process is used in the manufacture of sulphuric acid.

• It has the lowest cost.• Much lead is used in the

chemical industry because of its resistance to corrosion

ADVANTAGES

• Lead has low melting and hence posses poor structural qualities.

• It has a high coefficient of expansion.

DISADVANTAGES

• It is used for cold water pipes, waste pipes and dilution tanks for laboratories.

USES

LEAD ALLOYS AND MODIFICATIONS:

Acid lead and copper leads are used in chemical industries.

Some metals are added to lead for altering properties.

SILVER AND COPPER:

Improve corrosion resistant.

Improve creep and fatigue resistant.

TIN,ARSENIC:

Hardens, steel melting point is low.

Lead lined steel structures are used for the construction

of pipes, valves, vessels designed for operations at high

temperature, fluctuating temperature or vacuum.

NON-METAL INORGANIC

GLASS

GLASSED STEEL

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 mixer

COMPOSITION

•It is chemically inert.•It is non corrosive.•It imparts no odor or taste to that of the product.•It is impermeable.

ADVANTAGES

• They are brittle and break easily.• They may crack when subject to sudden

changes of temperatures,• They are heavier in comparison to plastic

containers.• Transparent glasses gives passage to UV-

light which may damage the photosensitive drugs inside the container.

DISADVANTAGES

• Mostly used in pharmaceutical industries as a containers.

USES

GLASS STEEL:

Glassed steel is cooled to a rigid condition without crystallizing.

It requires special consideration in its design and use.

Glassed steel combines the corrosion resistance of glass with the working strength of steel.

• Excellent resistant to all acids.• It can be attacked by hot alkaline

solution.• Acid resistant glass with improved

alkali resistance.

ADVANTAGES

• Used for strong acids, alkali and saline solution.

• For small scale manufacture and pilot plant work glassed steel vessels are used.

USES

NON-METAL ORGANIC

RUBBER

PLASTIC

RUBBER:

Used as such lining material for the construction of plants.

Type of rubber:

I. Natural rubber.

II. Soft-rubber.

III. Hard-rubber.

IV. Synthetic rubber.

NATURAL RUBBER

• Rubber is naturally occurring polymer obtained as latex from rubber tress.

• It is common example of an elastomer.

• Elastomer is a substance that can be stretched readily regains its original from.

SOFT RUBBER

• The naturally occurring polymer is known as soft rubber.

• It is a polymer of monomeric isoprene.

• It is resistant to dil. Mineral acids, dil. Alkalis and salts.

• Used lining materials for plants.• Used in making tyres ,tubes and

conveyor belt.

HARD RUBBER

• Soft rubber with >25% sulphur is know as hard rubber.

• Hard rubber is used for making gloves, bands, tubes and stoppers.

SYNTHETIC RUBBER

• Synthetic rubber is resistant to oxidation, solvent , oils and other chemicals.

• Synthetic rubber is thermoplastic.

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

PLASTIC:

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.

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

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 PLASTIC:

BASED ON UTILITY OF PLASTIC:

Rigid materials.

Flexible materials.

Metallic surfaces.

Plastic cements.

Special case plastic.

RIGID MATERIALS:

These are phenolic resins with resins various inert filler.

Used in fabrication of number of items.

Light in weight.

Used in gears, pipes ,fittings, ducts, valves, vessels.

Resistant to corrosion except oxidizing substance and strong alkali.

FLEXIBLE MATERIALS:

These are thermo plastic materials.

These materials can be rigid or flexible depending upon the amount of plasticizer added.

They are used in fabrication of tanks, pipes , funnel, buckets.

METALLIC SURFACE:

Plastics of polyethylene or polyvinyl chloride types are used along with plasticizer for the coating of metallic surfaces.

These are used to protect the metal from corrosion.

These linings are applied on tanks, vessels ,stirrer and fans.

PLASTIC CEMENTS:

Used for spaces between acid resistant tiles and bricks.

SPECIAL CASE:

Plastics are used as guards for moving parts of machinery.

Nylon and PVC fibers woven into filters cloth and are used for aseptic screening.

Packaging is one of the most important part of pharmaceutical industries .

Product produced is might be of vary good quality at the time production but it is useless if is not able to reach as it is up to end user.

Quality Maintenance is the major role played by packaging material .Along with that it gives pharmaceutical elegance and convenience to user to product .

Many times the Packaging is may become a ideal unique identification for some of brand in market .Quality control of such important part is also a vary valuable work.

Conclusion :

REFERENCES

Packaging materials “ Leon Lachman and Herbert A. Lieberman”.

Materials of plant pharmaceutical plant construction “Copper and Gunn's” tutorial pharmacy.

Packaging materials R.M.MEHTA Pharmaceutics-I

Prof .Dr. M.B.Venkatapathi Raju Sir,Principal,SRCP.Prof : G.Sudhakar sir , Vice principal,SRCP.Prof .Dr. R. Santosh Kumar sir , H.O.D,SRCP.

My Teachers and other faculty members and non teaching staff,SRCP.

Finally special thanks to Srinivasa Rao College of Pharmacy Management.

Hearty thanks to

Thank you