Materials of Pharmaceutical Plant Construction

&
Corrosion

Dr. Anita Singh

 Introduction
 A number of equipment are used in the manufacture of
pharmaceutical, bulk drugs, antibiotics, biological
products etc.
 A wide variety of material can be utilized for the
construction of equipment.
 The success and failure of plant is depend on:
 Design of equipment

 Selection of material

 Technique of fabrication
 The selection of material for the construction of
equipment depends on the following properties.
Chemical resistance

Structure strength

Resistance to physical shock

Resistance to thermal shock

Ease of fabrication

Cost

Maintenance Mainly
Factors Influencing the Selection of Materials

 Chemical Factors

 Physical Factors
Strength
Thermal conductivity
Thermal expansion
Ease of fabrication
Cleaning
Sterilization
Transparency

 Economic Factors
 Chemical Factors

 When the containers, equipments and product are come in

contact with each other, the effects may be understood in
two ways:

1) The consents may react and thus get contaminated

with the material of the plant.

2) The drugs and chemical may destroy the material

of the plant.
 Product may contaminated by material of equipments and
lead to instability, decomposition and physiological effects.
 The solvent action may cause corrosion, so that the trace of
metal ions used in construction tend to pass into solution and
contaminate the product. e.g. – presence of traces of heavy
metal decompose penicillin.
 Substance such as glass, silica, lead, cast iron steel etc are
used in construction of a plant and most of them produce
contamination. e.g. the color of esters will change to pale
yellow in presence of iron impurities.
 In industry equipment are exposed to extremes of pH,
temperature and pressure.
 As a result, the material gets corroded, losing its strength
and durability. So the life of the equipment is reduced.
 Materials of plants construction assists greatly in
providing a plant that will be resistant to attack of acids,
alkalis, oxidizing agents etc.
 Physical Factors
Strength:
 The material should have sufficient strength so that it can
withstand stresses e.g. In the compression of tablets, the dies and
punches should have sufficient mechanical strength to transmit
the applied pressure, iron and stainless steel can satisfy this
problem .
 Aerosol containers must withstand pressure as high as 960kPa to
1.20 Mpa at 55oC. Tin plate containers can satisfy this
condition, while plastic containers can’t be used due to its
poor mechanical strength.
 Mass:

 Many times, the equipment should be transported or

moved from one place to another.
 This is possible when the material is light in weight.

 Thermal conductivity:

 In pharmaceutical and chemical industries several

instruments and equipments such as evaporators, dryers,
stills and heat exchanger are used.
 The material employed for their fabrication should have
good thermal conductivity.
 Thermal Expansion:

 When the temperature changes the material undergoes in

stress and the risk of fracture increases.
 So that the material should be able to maintain size and
shape of equipment at working temperature.
 Ease of Fabrication:

 During fabrication the material undergoes various process

such as casting, welding, forging, etc.
 So the material of construction should be easy to
fabricate.
 Cleaning:

 Smooth and polished surface allow the process of

cleaning easily e.g. Glass & Stainless steel are suitable
for this purpose.
 Sterilization:

 In the production of parenterals products, ophthalmic,

antibiotics and biologicals, sterilization is an essential
step, which is obtained by autoclaving.
 So that the material should be capable to tolerate the
high temperature and pressure.
 Transparency:

Transparency is a useful property because it permits the

visual observation of the changes during a process.
For this purpose, borosilicate glass has been used in
the construction of reactors, fermentors etc.
 Economical Factor:

Cost and maintenance of the plant must be economical.

The cost is made up of three parts:
1. The basic cost of material
2. The fabrication cost
3. The scrap value of the plant at the end of its life.
Thank You
Materials of Pharmaceutical Plant Construction
&
Corrosion

Dr. Anita Singh

 CORROSION
 Corrodere (Latin) – To eat away
 Corrosion is defined as the reaction of a metallic material with
its environment (air, water and caustic chemicals) which
causes the measurable changes to the material and can result
in a functional failure of metallic component or of a complete
system.
 The compound that is formed during corrosion is referred to as
corrosion product and the metal is referred to as corroded.
 The corrosion media are generally liquid (mostly aqueous
solution), but also solids and gases.
 Types of Corrosion
 Corrosion can be either dry corrosion or wet corrosion type:

 Dry corrosion or Chemical Corrosion:

 It involves the direct attack of dry gases (air and oxygen)

on the metals through chemical reactions.
 As a result an oxide layer is formed over the surface.

 Due to this oxide layer total metal gets destroyed e.g.

Aluminium oxide layer on Aluminium.
 This type of corrosion is not common.
 Wet corrosion or electrochemical corrosion:

 It involves the direct attack of aqueous media (strong or

dilute, acidic or alkaline) on metal through
electrochemical reactions.
 The moisture and oxygen are also responsible.

 This type of corrosion is quite common.

 THEORIES/MECHANISM OF CORROSION

 The metal surface undergoes an electrochemical reaction

with moisture and moisture and in the atmosphere.
 This theory is known as electrochemical theory of corrosion.

 The mechanism involves the formation of a galvanic cell

(anodic and cathodic areas), by different metals (e.g. Fe and
Cu) or in different areas on the same piece of metal (e.g.
iron).
 When Galvanic cell are formed on different metal it is
known as Galvanic corrosion.
Corrosion reaction on Single Metal:
 Electrochemical reaction are illustrated by considering the
corrosion on a piece of iron in Hydrochloric acid (HCL).

Reaction on Anode:
Oxidation takes place with the release of electrons
at anode (oxidation) Fe -----> Fe+++ 2e- (indicated by rough surface)
Reaction on Cathode:
 The free electrons reach the cathode and react with some
positively charged species such as hydrogen ions in the
electrolyte solution.
 In the absence of acid, water itself dissociates to generate
H+ ions.
At anode (indicated by formation
(oxidation 2H+ + 2e- -----> H2 of bubble at surface)
)
The amount of metal (iron) which is dissolved in the
electrolyte is proportional to the number of electrons
flowing.
The overall reaction:

Fe + 2H2O -----> Fe(OH)2 + H2

(red-brown rust)
Corrosion Reaction Between Metal:
 Galvanic corrosion result from the flow of current from a
more active metal (anode) to a less active metal (cathode).
At anode (indicated by
(oxidation
)
Zn -----> Zn+++ 2e- rough surface)

At anode
(indicated by formation
(oxidation
)
2H + 2e -----> H2
+ -
of bubble at surface)

Corrosion Involving Oxygen:

 The oxygen dissolved in an electrolyte can react with
accumulated hydrogen to form water.
(indicated by formation
(At cathode )
O2 + 2H2 -----> 2H2O of bubble at surface)
 TYPES OF CORROSION
 Corrosion can be broadly classified as follows:
1. Fluid corrosion, General
 Physicochemical
 Electrochemical
2. Fluid corrosion, Localized
 Site specific
 Stress induced
 Flow related corrosion
 Chemical reaction related corrosion
3. Fluid corrosion, Structural
 Graphite corrosion
 Dezincification
4. Fluid corrosion, Biological
 Fluid corrosion: General
 When corrosion is generally confined to a metal surface, it’s
known as general corrosion.
 This type occurs in a uniform fashion over the entire exposed
surface area at a wide range of temperatures.
 General corrosion is of two types:
 Physicochemical Corrosion: The effects of this type are
swelling, cracking, crazing, softening etc. Examples are plastic
and nonmetallic material.
 Electrochemical Corrosion: This type of corrosion occurs at
discrete points of metallic surfaces when electricity flows from
cathodic area to anodic area.
Metallic surface gets divided into anodic portion or cathodic
portion.
 2. Fluid Corrosion- Localized

Specific site Stress induced Flow related Chemical reaction

Corrosion Corrosion Corrosion related Corrosion

Inter- Stress Impingement Galvanic

granular Corrosion corrosion corrosion
Corrosion cracking
Oxygen
Pitting Corrosion Erosion concentration
corrosion fatigue cell
Cervice Cavitation Hydrogen
Fretting Erosion embrittlement
corrosion
corrosion
 Fluid corrosion: General
 Localized Fluid corrosion is most frequently observed on
different locations in a material. It occurs in numerous ways.
 Specific site corrosion: Mechanically weak spots or dead
spots in a reaction vessel cause specific site corrosion.
 It can be further classified as-
 Inter-granular corrosion: Selective corrosion that occurs
in grain boundaries in a metal alloy is called inter-granular
corrosion.
 Pitting corrosion: This type of corrosion results in
development of pits and cavities. They range from deep
cavities to shallow depression.
 Cervice corrosion: In this type, corrosion occurs in
cervices because solutions are retained at such places,
which takes longer time to dry out.
 Stress induced corrosion: Residual internal stress in the metal or
external applied stress accelerates the corrosion.
 Residual internal stress is produced by:

 Deformation during fabrication

 Unequal rate of cooling from high temperature

 Internal stress rearrangement involving volume change.

 It can be further classified as:

 Stress corrosion cracking

 Corrosion fatigue

 Fretting corrosion
 Flow related corrosion: Liquid metals can cause corrosion.
Usually the driving force is the tendency of the liquid to
dissolve solids or penetrating the metal along the grain
boundaries at places of wetting. .
 It can be further classified as-
 Impingement corrosion: It is also known as erosion-
corrosion or velocity accelerated corrosion. It is accelerated
by removal of corrosive products (such as oxide films).
 Erosion: Erosion is the destruction caused by the flow of
liquid/gas (with or without suspended solids).
 Cavitation erosion: Formation of transient voids or
vacuum bubbles in a liquid stream passing over a surface is
known as cavitation.
 Chemical reaction related corrosion: Corrosion involves
chemical reaction such as oxidation and reduction at anode and
cathode, respectively.
 It can be further classified as:
 Galvanic corrosion: It is associated with the flow of a less-
active metal (copper cathode) from a more reactive metal
(zinc anode) in the same environment.
 Oxygen concentration cell: This type of corrosion is due
to the presence of oxygen electrolytic cell, i.e., a difference
in amount of oxygen in solution at one point exist when
compared to another.
 Hydrogen embrittlement: Hydrogen can penetrate carbon
steel and reacts with carbon to form methane. The removal
of carbon results in decreased strength.
 Fluid corrosion: Structural
 In the structural fluid corrosion type, the structural
(mechanical) strength is reduced on account of corrosion.
 This may occur when one component of alloy is removed or
released into the solution.
 Some examples are:
 Graphite corrosion: Graphite is an allotropy of carbon
and occurs in gray cast iron.
 When carbon steel is heated for prolonged period at
temperature higher than 455oC, Carbon may get segregated,
which is then transformed in to Graphite.
 Hence structural strength of steel is affected.
 Dezincification: This type of corrosion is seen in brass that
contains more than 15% zinc.
 Fluid corrosion: Biological
 The metabolic action of microorganism can either directly or
indirectly cause deterioration of a metal. Such a process is
called biological corrosion.
 Microorganisms associated with corrosion are either aerobic
or anaerobic.
 The causes of biological corrosion are:
 Producing corrosive environment or altering
environmental composition.
 Creatin electrolyte-concentration cells on the metal
surface.
 Altering resistance to surface films.
 Influencing the rate of anodic/cathodic reaction.
Example:
 The role of biological corrosion may be explained using
anaerobic sulphate using bacteria in slightly acidic or
alkaline soils.
 As these bacteria thrive under these conditions, they will
continue to promote this reaction until failure of the pipe
occurs.
PREVENTION AND CONTROL OF CORROSION

Selection of proper material

Proper design of equipment

Coating and linings

Altering environment

Inhibitors

Cathodic protection

Anodic protection
 Selection of proper material
 Corrosion should not be permitted in fine mesh wire-
screens, orifices and other items in which dimensions are
critical and changes are not permitted.
 Non-metallic materials are useful and attractive from the
point of view of economics and performance
 Proper design of equipment
 In designing of equipment, a number of fittings such as
baffles, stiffeners, drain nozzles, location of valves and
pumps should be considered.
 Corrosion can be minimized, if equipment designed
facilitates:
Elimination of crevices
Complete drainage of liquids
Ease of cleaning
Ease of inspection and maintenance
 Coating and linings
 Organic coatings are used as linings in equipment such as
tanks piping, pumping lines and shipping containers.
 Some examples of linings are:
 Ceramic, Carbon brick, Plastic, Elastic, Glass coated, Organic

 Tin coated steel (tin plate) used for food containers.

 Lead coating for roofing

 Aluminium coated steel for high temperature conditions

 Altering environment
 Corrosion can be combated or reduced by employing the
following environmental conditions.
Removing air from boiler feed

Reducing aeration prevents the formation of passive

oxide film in stainless steel.
Reducing the temperature

Eliminating the moisture

Reducing the velocity or turbulence

Shortening the time of exposure

  Inhibitors
 The corrosion inhibitors are added to the environment to
decrease the corrosion of metals.
 These forms protective films.
Adsorption type, for example, adsorbed on the metal.
Scavenger type, for example, remove corrosion agents.
Vapor phase type, for example, sublime or condense on
metal surface.
 Inhibitors Material protected in media
Chromate, Phosphate - Iron and steel in aqueous solution
Organic sulphides, amines - Iron and steel in acidic medium
Copper sulphate - Stain less steel in hot dilute
solution of sulphuric acid
 Cathodic protection
 The cathodic protection is based on the Galvanic action
between the metal of the plant and anode suspended in
solution.
 The metal to be protected is made a cathode i.e. electrons
are supplied, there by dissolution of metal is suppressed.
 This can be achieved by two methods-

Sacrificial anode method

Impressed emf method

 Anodic protection
 In this method, a predetermined potential is applied to the
metal specimen and the corresponding current changes are
observed.
 During the initial stage, the current increases, indicating
the dissolution (corrosion) of the metal.
 When the current reaches a critical point, passivation
occurs i.e. the oxide layer sets in a suitable oxidizing
environment.
 The potential at critical point is called Passivating potential.
 The Passivating current is defined as the minimum
protective current density required to maintain
passivisation.
 Advantage:

it requires a small current.

 Disadvantage:

Corrosion can not be reduced to zero.

This method can not be applied for those metals which

do not passivate.
Thank You
Materials of Pharmaceutical Plant Construction
&
Corrosion

Dr. Anita Singh

Material of pharmaceutical plant construction can be classified as:

Material of Construction

Metals Non Metals

Ferrous Non Ferrous Organic Inorganic

Aluminium Plastics Glass

Cast Iron
Steel Carbon Lead Rubber
Stainless Steel
 Ferrous Metals
 Iron metal is one of the widely used materials for the
construction of plants because of its mechanical strength,
abundant availability and lower cost.
 Some varieties of iron are discussed here,

Cast iron

Steel carbon

Stainless steel
 Cast Iron
 Cast iron consist of iron with a proportion of Carbon (beyond
1.5%)
 Its property is depend on the amount of carbon present in it.
 Cast iron is different types:
 Grey cast iron Maleable cast iron
 High silicon cast iron Nickel resistant cast iron
Advantage of Cast iron:
Cheap
It is resistance to conc. H2SO4, nitric acid and dil. Alkalis.
It has thermal conductivity,.
Disadvantage of Cast iron:
Cast iron is very hard and brittle.
Cast iron is attacked by dil. H2SO4
Carbon Steel or Mild Steel:
 Carbon steel is iron alloy, which contains only a small
percentage of carbon.
Advantages of Carbon steel:
 Cheapest, therefore it is preferred.
 Weldable and frequently used in fabrication.
Disadvantages of Carbon steel:
 Limited resistance to corrosion
 It react with caustic soda, sea-water etc.
Uses:
 Construction of bars, pipes and plates.
 Storage tanks for water, H2SO4, water and organic solvent,
etc.
The different types of alloys of carbon steel:
 Low alloy steel- High mechanical strength

 Alloying with Nickel- Increased hardness

 Alloying with silicon chromium- Corrosion resistance

Stainless Steel
 Stainless steel (SS) is an alloy of iron.
 Usually it contains Chromium and Nickel which make the steel
corrosion resistant.
 Stainless steel is stabilized by the addition of Titanium, Niobium
or Tantalum.
Advantages of SS:
 Heat resistance Corrosion resistance
 Ease of fabrication Cleaning and sterilization
 Tensile strength

Depending on the composition, SS alloys are available in

three groups:
1) Marten sic- e.g. Type 410
2) Ferritic- e.g. Type 430
3) Austenitic- e.g. Type γ
Non-Ferrous Metals
 Aluminium  Chromium

 Lead  Titanium

 Silver  Platinum

 Copper & Copper alloys  Zirconium

 Tin  Tantalum

 Nickel

But here widely Aluminium, copper and lead is used.

Aluminium:
 A number of Aluninium items are use in regular daily life.
Advantages of Aluminium:
Cheap, Light in weight, Adequate Mechanical strength
Easily fabricated, Maintenance & cleaning is also easy.
High resistance to atmospheric conditions, industrial
fumes, vapor and fresh or salts waters.
Disadvantages of Aluminium:
The mechanical strength decreases greatly above 150oC.
Can’t be used with strong caustic solution.
Many mineral acids attack aluminium.
Uses of Aluminium:
A super grade is used for food and pharmaceutical use.
Used in many heat transfer applications.
Used for meat storage containers.
Lead:
• Lead has the lowest cost and is used as collapsible tube material
particularity for non-food products such as adhesive, inks,
paints and lubricants.
Disadvantage of Lead:
 Lead has low melting point and hence possesses poor
structural qualities.
 Temperature strain causes permanent deformation.
 Risk of toxicity.

Uses of Lead:
It is used in chemical industries.
Construction of clod water pipes, waste pipes, valves etc.
Copper & Copper Alloys:
Properties of copper & Copper alloys:
 It is malleable and ductility, so easily fabricated.
 Copper is preferred when good electrical and thermal
conductivity is required.
 It is inexpensive and possess good mechanical strength.
 It is fabricated in wide verity of shapes.
 Copper exhibit good corrosion resistance to strong alkali.
 It resist most organic solvents and aqueous solution of organic
acids.
Uses of Copper:
It is used for evaporator, pans, stills, fractionating columns.
For piping of water, gas, vacuums and low pressure steam.
It is widely used for organics and brewing and food
industries. 
Tin:
Tin has high resistance to a variety of substances

Its salts are non-toxic

Tin is widely used in food industry

Foods are packed in tin cans.

Silver:
 Silver is generally used only in the form of lining because of
its low mechanical strength and high cost.
 It is resistance to organic acid but not to concentrated acids
i.e. HCl, H2SO4
NON METALS: Inorganic
GLASS:
Glass is considered as super cooled liquid, though it is seen
in solid state.
The constituents are present in amorphous state.
Glass has the advantage of superior protective qualities,
attractiveness and low cost.
It is chemically inert to a large range extent and available in
variety of sizes, shape and color.
Glass containers practically offer excellent barrier against
every element except light.
UV rays and sunlight are harmful to certain ingredients and
bring about chemical deterioration.
Protective action against light can be achieved by amber-
colored glass.
  Glass is composed of the following constituent:
 Sand– silica pure(SiO2) – based material
 Soda ash – sodium carbonate(Na2Co3) – improves the properties
 Lime stone – calcium carbonate(CaCO3) – improves the properties
 Cullet– broken glass – fusion agents
 Silicon dioxide- tetrahedron structure- more resistance but brittle

Some varieties of glasses are:

 Soft glass (soda glass): Sodium/calcium silicate
 Hard glass (potash glass): Potassium/calcium silicate
 Jena glass : Zinc glass
 Pyrex glass: Boron oxide/sodium oxide
 Quartz glass: Pure silica
Types of glasses used in pharmaceutical industry
IP

Types Properties Uses

Type-I Resistant to alkali leaching, Used for buffered and

(Highly resistant less brittle, low thermal unbuffered, injectables
Borosilicate) expansion easy to clean aqueous solutions.
and sterile.

Type-II Sulphur alkali is neutralize Containers for buffered

(Treated by sulphur oxide vapors. aqueous solution with pH
soda-lime glass) Glass surface is resistance below 7.0, dry powders,
to water. oleaginous solutions.
Types of glasses used in pharmaceutical industry
IP
Types Properties Uses

Type-III It release comparatively Dry powders, oleaginous

(Soda-lime glass) more alkali. If offers solutions
moderate hydrolytic
resistance

Type-IV Not for parenterals, used as

(General purpose containers for tablets, oral
soda-lime glass) solutions, suspensions,
ointments and liquids for
external use.
NON METALS: Organic
Plastics:
 Plastic are synthetic resins contain long chains of atoms liked to
from giant macromolecules.
 They have molecular weight.(103 to 107).
Advantages of Plastics:
 Low thermal and electrical resistance
 Excellent resistance to weak mineral acids.
 Unaffected by inorganic salts.
 Resistance to slight changes in pH.

Disadvantages of plastics:
 Low thermal and electrical strength.
 High expansion rates.
 In pharmaceutical industry two type of plastic are used.
1)Thermosetting plastic – Its can be formed under heat and
pressure but these can’t be softened or remolded,
once hardened. – Some are made from Phenolic and Urea
resins.

Some thermoplastic materials and their uses are:

Polyethylene - cables, buckets, pipes

Polypropylene – milk cartons, ropes

Polyvinyl chloride – gloves, water proof garments

Teflon – gaskets, coatings

2) Thermoplastic plastic – Its also made up from heat and
pressure but these are softened and remolded.
Types of thermoplastic are:
1. Polyolefin's
a) Low density polyethylene (LDP)
b) High density polyethylene (HDP)
c) Poly propylene (PP)
2. Polystyrene
3. Polyvinyl chloride (PVC)
4. Polycarbonate
5. Polymethyl - methacrylate (PMMA)
6. Poly amides (NYLONS)
7. Polytetrafluro Ethylene (PTEE)
 Plastics is used as:

Containers for transfusion solution and retention enemas.

Containers for Eye and Ear drops, nasal sprays.

Eye ointment tubes.

Spray bottles – squeeze bottle.

Suppositories pack.

Flexible packing.

Bottles, jars and closures.

Rubber
 Rubber is used as such or as lining material for the construction
off plant. Both nature and synthetic rubber are used.
Types of Rubber:
 Natural rubber
 Soft rubber
 Hard rubber
 Synthetic rubber
 Neoprene
 Nitrile rubber
 Butyl rubber
 Silicon rubber
 Polyisoprene 
Ideal Quality of Rubber for Closure
Compatible with product
Oil resisting for oily preparation
Provide air tight closing
Negligible extraction of preparation ingredients
Withstand sterilization temp
Softness and elasticity
Impermeable to air and moisture
Do not migrate any additive to the preparation
Good ageing qualities
Do not yield any fragments
 Natural Rubber:
 Natural rubber is a naturally occurring polymer, which is
obtain as latex from rubber tree.
 It is common example of an elastomer.
Elastomer is a substance that can be stretched readily
and when released, rapidly regains its original from.
 Soft Rubber:
 The naturally occurring polymer is known as soft rubber.
 It is a polymer of monomeric isoprene (C5H8).
 Its advantage is resistant to dilute mineral acids, dil. Alkali
and salts
 Hard Rubber:

 When soft rubber is mixed with sulphur, warmed and set

into a given shape, it retains its from.
 The sulphur combines with the polymeric chains of rubber
and cross-links between them.
 This process is called vulcanization

 Synthetic Rubber:

 Synthetic rubber has taken greater importance over natural

rubber due to its superiority in properties such as resistance
to oxidation, solvents, oils and other chemicals.
Thank You