SUBJECT:-Pharmaceutical engineering 1 CONTENTS -general study of composition -properties factors affecting the selection of material of pharmaceutical plant -construction with special reference to S.S and glass

1. Pharmaceutical Engineering - 1
Vishvajitsinh Bhati 1

2. Pharmaceutical Engineering -1
Course contents
1. Introduction
2. Stoichiometry
3. Fluid flow
4. Material handing systems
5. Heat transfer
6. Mass transfer
7. Materials of Pharmaceutical Plant construction.2Vishvajitsinh Bhati

3. Chapter :- Materials of Pharmaceutical
Plant Construction
Covered points
1. General study of composition
2. Factors affecting the selection of material of
pharmaceutical plant
3. Corrosion, corrosion resistance & Properties
4. Corrosion-types, cause, theory of corrosion & its
prevention.
5. Construction with special reference to stainless
steel & glass.
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4. Factors Influencing The Selection Of
Materials
• A number of equipment are used in the manufacture of
pharmaceutical, bulk drugs, antibiotics, biological products etc.
• In addition, several accessories such as containers for
processing and packing of finished products are essential.
• A wide variety of material can be utilized for the construction
of equipment.
• In the plant improvement is depend on->(1) Design of
equipment (2) Selection of material (3)Technique of
fabrication.
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5. • The selection of material for the construction of equipment depends on the
following properties..
1. Chemical factors
2. Physical factors
3. Economical factors
• Sub-factors is..
a) Chemical resistance
b) Structure strength
c) Resistance to physical shock
d) Resistance to thermal shock
e) Ease of fabrication
f) Cost
g) Maintenance
Mainly 3 factors are affected
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6. Chemical Factors
• The contents should not alter the properties of the material with
which the vessel is made, when these are 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.
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7. Conti..
1)…Product may contaminated by material of equipments and
lead to instability, decomposition and physiological effects, it
may also affect physical properties of products like appearance
and color.
Eg. – presence of traces of heavy metal decompose penicillin
-Stability of vit. Decreased in presence of metallic ions.
-The color of esters will change to pale yellow in presence of
iron impurities.
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8. 2)…the solutions that come into contact with the equipment are
generally corrosive in nature.
• In addition, 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.
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9. Physical Factors
I. Strength
II. Wear properties
III. Sterilisation
IV. Cleaning
V. Mass
VI. Thermal conductivity
VII.Thermal expansion
VIII.Ease of fabrication
IX. transparency 9Vishvajitsinh Bhati

10. Strength
• In the compression of tablets, the dies and punches
should have sufficient mechanical strength to
transmit the applied pressure, otherwise tablets are
poorly formed.
• Glass satisfies the property of strength, but is
breakable.
• Here, 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.
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11. Wear Properties
• There properties become important, when there is a possibility
of friction between the moving parts.
–Eg. During milling and grinding, the gridding surface wear
off and these materials will be incorporated into powder as
impurities.
–Such type of mills should be avoided, when drugs of high
purity are required.
–The risk of contamination is more due to wear of ceramic or
iron equipment.
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12. Sterilisation
• In the production of parenterals products, antibiotics and
biological, sterilisation is an essential step, which is obtained
by autoclaving.
–E.g. Equipment and vessels are made of S.S, because they
can be sterilised easily.
Cleaning
• Smooth and polished surface allow the process of cleaning
easily
–E.g. S.S & Glass are suitable for this purpose.
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13. 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, when other factors are satisfactory.
Thermal conductivity
• In industries some time equipment such as evaporators, dryers,
stills and heat exchanger are used, for used good thermal
conductivity materials.
–E.g. iron, glass or graphite tubes are used in the fabrication
of heat exchangers, so that effective heat transfer is possible.
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14. Thermal Expansion
• If the material has high coefficient of expansion, the design of
plants may be greatly complicated.
• This increases should be able to maintain size and shape of
equipment at working temperatures.
• 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..
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15. Transparency
• Transparency may be useful property because it
permits the visual observation of the changes
during a process.
• For this resone, borosilicate glass has been use
increasing used in the construction of reactors,
fermentors etc…
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16. 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.
• It can happen that an apparently expensive material will be
the most economical in long run.
– E.g. -: Sub. With better wearing qualities and lower
maintenance cost. 16Vishvajitsinh Bhati

17. Classification of Materials for Plant
Construction
Material of construction
Non-metals
Ferrous
Metals
Cast iron
Glass
PlasticRubber
Organic
Inorgani
c
Lead aluminium
Non-ferrous
Stainless
carbon
Stainless
steel
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18. 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,
1. Cast iron
2. Steel carbon
3. Stainless steel
18Vishvajitsinh Bhati

19. Cast Iron
• Consists :Fe + carbon (1.7+5.0%)+ silicone (Si) + manganese
(Mn)
• Its property is depend on the amount of carbon present in it.
• Cast iron is abundantly available, inexpensive and widely used.
• There is two type of cast iron.
–1) White cast iron
–2) Grey cast iron
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20. 1) White cast iron: upon fracture it gives a while surface.
• it contains the carbon in the from of the cementite, and is
produced by rapid cooling.
• It is malleable. It is very abrasive and wear resistance. It is
used as liner, for grinding balls, dies and pumps impellers.
2) Grey cast iron: it consist less cementite, its carbon occurs in
the form of graphite.
• Grey cast iron is much less hard and brittle than white cast
iron.
• Low in cost and easy to cast
20Vishvajitsinh Bhati

21. • It has outstanding ability to absorb vibration and wear
resistance.
• Uses:
– Supports for plants
– Jackets of steam pans
– Linings with enamel, plastic or suitable protective material.
– 14% addition of silicon in cast iron a hard and brittle
casting alloys is formed, which is resistance to attack by
HNO3 or H2SO4.
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22. • Advantage:
–Cheap, it is used in place of expensive plant material with
coatings or linings of enamel or plastic.
–It is resistance to conc. H2SO4 , nitric acid and dil. Alkalis.
–Since cast iron has thermal conductivity, it is used for the
construction of outer surface of jackets of steam pans.
• Disadvantage:
–Cast iron is very hard and brittle.
–Cast iron is attacked by dil. H2SO4 , dil. nitric acid, and as
well as conc. HCL acid.
–Since cast iron has low thermal conductivity, it can’t be used
for heat transfer in stills. 22Vishvajitsinh Bhati

23. Carbon Steel or Mild Steel
• Carbon steel is iron alloy, which contains only a small
percentage of carbon.
• Variants of carbon steel:- the property of carbon steel can be
altered by alloying it with other metals and their properties are…
–Nickel (Ni):- improves toughness, corrosion resistance and
low temperature to oxidation.
–Chromium (Cr):- increase hardness, more abrasive resistance
to oxidation.
–Silicon (Si):- increases hardness, more abrasive resistance to
oxidation
–Molybdenum (Mb):- provides strength at elevated temp. 23Vishvajitsinh Bhati

24. • Uses:
– Construction of bars, pipes and plates.
– Storage tanks for water, H2SO4 , HCL and organic solvent, etc..
– Supporting structure such as grinders and bases for plant vessels.
• Advantages:
– Cheapest, therefore it is preferred.
– wieldable and frequently used in fabrication.
• Disadvantages:
– Limited resistance to corrosion
– Its react with caustic soda, brine water and sea-water.
24Vishvajitsinh Bhati

25. Stainless Steel
• There are more than 70 standard types of steel.
• S.S-302 Contains – Fe + Cr (18%) + Ni (8%) + C (0.08%)
• S.S-304 Contains – Fe + Cr (19%) + Ni (9%) + C (0.08%)
• The abundant use of S.S is due to the properties such as:
–Heat resistance
–Corrosion resistance
–Ease of fabrication
–Cleaning and sterilisation
–Tensile strength
25Vishvajitsinh Bhati

26. • Depending on the composition, S.S alloys are
available in three groups, viz., marten sic, ferritic
and austenitic.
Composition Advantage Disadvantage Uses
Mertensitic :
Chromium 12-20%
Carbon 0.2- 0.4%
Nickel up to 2.0%
Mildly corrosion
resistance, atmospheric
& organic exposures.
Ductility is poor Sinks, bench tops,
storage tanks, buckets,
mixing elements etc..
Ferritic (α- form)
Chromium: 15-30%
Carbon: 0.1%
Nickel: -
Better corrosion
resistance, easy to
machine, resistant to
oxidation and
temp.(upto-800oc)
Not good against
reducing agents , HCL
Tower linings, baffles,
separator, tower, heat
exchanger, tubings,
condensers, furnace
parts, pumps shafts,
valve parts.
Austenitic (γ-forms)
Chromium: 13-20%
Nickel: 6-22%
Carbon: 0.1%<0.25%
Highly corrosion
resistant, readily cleaned,
sterilizable, ease to weld,
non-magnetic
Not easy to machine Fermentors, storage
vessels, evaporators,
extraction vessels, small
apparatus. 26Vishvajitsinh Bhati

27. Non-Ferrous Metals
oSilver
oNickel
oChromium
oZirconium
oTantalum
oPlatinum
oCopper
oCopper alloys
oAluminium
oLead
oTitanium
oTin
27Vishvajitsinh Bhati

28. • But here widely Aluminium, copper and lead is used.
•Aluminium•
• A number of ‘Al’ items are use in regular day to day life.
• Resone is :-
–Cheap
–Light in weight
–Mechanical strength
–Easily fabricated
–Maintenance & cleaning is also easy.
28Vishvajitsinh Bhati

29. • Aluminium alloys and modifications:-
–A number of ‘Al’ alloys are available with improved
qualities and mechanical properties.
–‘Al’ alloys are used in the construction of equipment
producing medicinal substance, since aluminium dose not
affect the salts
–Aluminium is non-toxic to microorganisms.
– it has considerable use in biosynthetic process such as the
production of citric acid gluconic acid and streptomycin by
deep culture method.
–It is most useful for the construction of containers namely
drums, barrels, rail tankers etc… 29Vishvajitsinh Bhati

30. • Advantages:
–High resistance to atmospheric conditions, industrial fumes,
vapor and fresh or salts waters. ‘Al’ can be used with conc.
HNO3 acid and acetic acid.
–Thermal conductivity of ‘Al’ is 60% that of pure copper.
• Disadvantages:
–The mechanical strength decreases greatly above 150oC.
–Al can’t be used with strong caustic solution.
–Many mineral acids attack aluminium.
–Oxide and hydro-oxide film is thickened by chemical and
electrolytic means. These provide so called anodized
finishes. 30Vishvajitsinh Bhati

31. Copper & Copper Alloys
• Properties of copper & Copper alloys
–It is malleable and ductility, so easily fabricated.
–It has high electrical and thermal conductivity.
–It can be hammered, welded, brazed and soldered, but dose
not cast well.
–It is readily formed into tubes and pans.
–Surface polish is high so it is easy to clean, so good heat
transfer surfaces.
–It resists non-oxidizing agent well.
–HNO3 attacks copper readily 31Vishvajitsinh Bhati

32. –Caustic alkali solution dissolve copper appreciably.
–It attacked by hot conc. HCL, H2SO4 And ammonia.
–Many drugs constituents react with it, and for this reason
copper is usually protected by a lining of Tin.
• Applications:
–It is used for evaporator, pans, stills, fractionating columns.
–For piping of cold water, gas, vacuums and low pressure
steam.
–It is widely used for organics and brewing and food
industries.
32Vishvajitsinh Bhati

33. Copper Alloys
• This alloys include with Zn, Al, Si, Ni, Tin etc..
1. Copper zinc alloys [ BRASSES ]
• Their corrosion resistance is less than that of copper so has limited
application in pharma. Plants.
• They are easily worked and their tensile strength is greater than
COPPER.
• Uses: prepare tubes, valves, nuts, bolts and rods.
2. Copper-Tin alloys [BRONZES]
• 2-13% of tin with small quantity of phosphorous and traces of other
elements, harder than brass.
• Uses: filter gauzes stirrers, valves, pumps, high pressure pipes,
special tablet punches and dies. 33Vishvajitsinh Bhati

34. Lead
• Lead has the lowest cost and is used as collapsible tube material
particularity for non-food products such as adhesive, inks, paints
and lubes.,
• Lead tubes with internal linings are sometimes used for fluoride
tooth-paste.
• Lead chamber process is used in the manufacture of H2SO4.
• Disadvantage:
– Lead has low melting point and hence possesses poor structural
qualities.
– It has high coefficient of expansion. So, temp. strain result in
permanent deformation. 34Vishvajitsinh Bhati

35. • Lead is little used in pharmaceutical practice ,
because of the risk of contamination even in traces
produces toxicity and of cumulative nature.
• Uses:
– It is used in chemical industries.
– Construction of clod water pipes, waste pipes and
dilution tanks for laboratories.
• Lead alloys and modification:-
– Silver and copper
• Improvement corrosion resistance
• Improvement creep and fatigue resistance.
– Antimony, Tin, Arsenic:-
• Hardness, still melting point is low.
35Vishvajitsinh Bhati

36. NON METALS - Inorganic
• GLASS :- a number of glass article are use in daily life. 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.
36Vishvajitsinh Bhati

37. • Protection against IR rays can be obtained by using green glass.
• The disadvantages are its fragility and weight.
• Glass is considered as super-cooled, through it is seen in solid
state. The constituents are present in amorphous state.
• Glass is composed of the following constituents…
– 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
• Some varieties of glasses are given in table ….
Vishvajitsinh Bhati 37

38. No Type Composition Remarks38 Application
1 Type-1
( Borosilicate
Or natural or Pyrex)
SiO2 – 80%
Al2O3 –
U.W%
Na2O – 7%
K2O – 0.5%
B2O3 - 12%
CaO – 1%
-Heat resistant
-Chemically inert than soda-
lime glass
-High hydrolytic resistance
-Leaching of NaOH only
0.5PPM per yr
-Difficult to melt and mould
-Very costly
-Chemical glass
ware
-Ovenware
-Container for
alkali sensitive
preparation
2 Type-2 Treated soda
lime glass
(soda-glass with
surface treatment,
sulphured containers)
SiO2 – 75%
Al2O3 – 2%
Na2O – 0-10%
K2O – 0-0.5%
B2O3 - 3%
CaO – 10%
-High hydrolytic resistance
due to surface treatment
-Softer than borosilicate easy
to mould
-Cheaper than borosilicate
-Containers for
Alkali sensitive
preparations
-For food blood,
plasma and
infusion fluids
-Parental
-Used once only.
Vishvajitsinh Bhati 38

39. No Type Composition Remarks Application
3 Type – 3
Soda-lime glass
ordinary glass
SiO2 – 75%
Al2O3 – 2%
Na2O – 15%
K2O – 0-
0.5%
B2O3 - 3%
CaO – 12%
-Moderated hydrolytic
resistance
-Easy to mould
-Yield alkali to water
-Flakes separate out
-Loss of brilliance
-Cheapest
-Medicated bottle
-Only for non-aqueous
liquid preparation
-For powders for
injection
-Not for alkali
sensitive products
-Not for Parental
-Used once only
4 Type-NP
(Non-Parental)
- - General purpose
soda-lime glass
- Use for oral and
topical preparation
39Vishvajitsinh Bhati

40. No Type Composition Remarks Application
5 Colored glass - In addition of glass
composition metal salts are
added carbon and sulplur
OR iron and manganese for
Amber color.
- Dose not allow
the U.V rays to
pass through.
-Used for sunlight
sensitive product
-Do not use for
parenterals unless
specified
6 Lead free glass - - As lead
monoxide is used
in manufacturing
of glass causes
lead poisoning
-Used for liquid
preparation
-Used when
preparation-ment
for lead poisoning
e.g. Na. E.D.T.A.
7 Silicone treated - Surface is treated with
dimethyl siloxane
- As hydrophobic
in nature do not
wetted so product
do not cling to
surface
-
40Vishvajitsinh Bhati

41. Glassed Steel
• Glassed steel is an organic product of fusion, which is cooled to a
rigid condition without crystallizing.
• It requires special consideration in its design and use.
• These surface are applied to heavy vessels.
• Normally, several coating are fused in furnace, glassed steel
combines the corrosion resistance of glass with the working
strength of steel.
• Uses:- glass lined steel is used for strong acid, alkalis and saline
solutions. For small-scale manufacture and pilot plant work,
glassed steel vessels are used.Vishvajitsinh Bhati 41

42. • Advantages:-
– It has excellent resistance to all acids except hydrofluoric acid and hot
conc. H2SO4.
– It can be attacked by hot Alkaline solution. Particularly suitable for
piping when transparency is desirable.
– It is brittle and gets damaged by thermal shock. Hence it is protected
using glass lined with epoxy polyester fiber glass.
• Glass lining are resistant to
– All conc. Of HCl acids up to 120oC.
– Dil. Conc. Of H2SO4 up to the boiling point.
– All conc. Of HNO3 up to boiling point.
– Acid resistance glass with improved alkali resistance (up to pH 12).
Vishvajitsinh Bhati 42

43. NON METALS - Organic
• Mainly 2 material are widely used in plant construction of this
group…
1. Rubber
2. Plastic
• Other is…
– Wood/Timber
– Carbon/Graphite
– Silica ware
Vishvajitsinh Bhati 43

44. 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..
I. Natural rubber
II. Soft rubber
III. Hard rubber
IV. Synthetic rubber
a. Neoprene
b. Nitrile rubber
c. Butyl rubber
d. Silicon rubber
e. polyisoprene
Vishvajitsinh Bhati 44

45. Ideal Quality of Rubber for Closure
1. Softness and elasticity
2. Impermeable to air and moisture
3. Provide air tight closing
4. Compatible with product
5. Do not migrate any additive to the preparation
6. Negligible extraction of preparation ingredients
7. Withstand sterilization temp.
8. Good ageing qualities
9. Oil resisting for oily preparation
10. Do not yield any fragments.
Vishvajitsinh Bhati 45

46. 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.
Vishvajitsinh Bhati 46

47. –It disadvantage is that soft rubber can be attacked by oxidizing
media, oils and organic solvents.
–Uses:- lining materials for plants, as it can bond easily to the
steel.
–After addition of carbon black to the soft rubber gives
hardened rubber. It is used for making tyres, tubes and
conveyor belts.
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 btwn them. This
process is called vulcanization.
–Soft rubber with 25% or more sulphure is known as hard
rubber. Vishvajitsinh Bhati 47

48. –Its advantages is hardness and strength.
–Uses:- for making gloves, bands, tubes and stoppers.
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.
–Here some type of synthetic rubber are describe in table..
Vishvajitsinh Bhati 48

49. Sr.
no
Synthetic
rubber
Properties uses
1. Neoprene
(Polychloro-prene)
•Dose not burn readily like
natural rubber
•Stable at high temp.
•Insulating material in
electric cables, conveyor
belts in coal mines, making
hoses in the transportation
of oils. Rubber stoppers,
cap-lines, dropper
assemblies for eye drops
etc.
2. Nitrile rubber •Resistance to oil and
solvents.
-
3. Butyl rubber •Resistance to..
- minerals acids & alkali
- conc. acids
•Used for closures of freeze
dried product containers
bcoz of its low water vapor
permeability.

50. •Synthetic rubber is thermoplastic, but when mixed with sulphur,
warmed and set into a given shape, it retains its from.
•Vulcanization of rubber it possible. It is used for making gloves,
bands and tubes, caps for vials.
Sr. no Synthetic
rubber
Properties uses
4. Silicon rubber
(Poly-siloxanes)
•Resistant to..
- high and low temp.
- attack to aliphatic
solvents, oils and
greases.
-
5. Polysoprene •Stable at high
temp., translucent,
flexible.
-
Vishvajitsinh Bhati 50

51. • Rubber is soft material, but can be hardened by adding carbon
black.
• Hardened rubber is used for making tubes, tyres and conveyor
belts.
PLASTIC
• Plastic is use in various way, and It is cheap and light in weight
so it is easily transpiration is easy.
• These available in variety of shapes implying that it can be easily
fabricated.
• Plastic material is used for storing a number of substance such as
inorganic salts and weak mineral acids.
Vishvajitsinh Bhati 51

52. • in machines, plastic material are preferred whenever moving
parts are present indicating that it offers less friction.
• These have better resistance to environmental factors, in similar
manner, plastic materials also used in the construction of plants.
• Plastic are synthetic resins contain long chains of atoms liked to
from giant macromolecules. They have molecular
weight.(103to107).
• Generally Advantages of PLASTIC.
I. Low thermal and electrical resistance
II. Excellent resistance to weak mineral acids.
III. Unaffected by inorganic salts.
IV. Resistance to slight changes in pH.
Vishvajitsinh Bhati 52

53. • Plastic have disadvantage like that….
I. Low thermal and electrical strength.
II. High expansion rates.
 Basically, two type of plastic are used in pharma. Industry.
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.
2) Thermoplastic plastic
– Its also made up from heat and pressure but these are
softened and remolded. This is a specific advantage.
Vishvajitsinh Bhati 53

54. • Some thermoplastic materials and their uses are given below..
– Polyethylene - cables, buckets, pipes
– Polypropylene – milk cartons, ropes
– Polyvinyl chloride – gloves, water proof garments
– Teflon – gaskets, coatings
• Based on the utility of plastic in plant construction, these can be
categorized as:
I. Rigid materials
II. Flexible material
III. Metallic material
IV. Plastic cements
V. Special case plastic
Vishvajitsinh Bhati 54

55. Rigid Materials
• These are phenolic resins with various inert fillers. These are
used in the fabrication of a number of items. For e.g. kibosh is a
rigid material and used for gears, bearing etc..It is light in weight.
Some of its application are… pumps, ducts, fittings, etc..
• Disadvantage :- these are resistant to corrosion except oxidizing
substance and strong alkalis.
Flexible Materials
• These material is can be rigid or flexible depending upon the
amount of plasticizer added. Used in fabrication..tanks, buckets,
funnels, pipes.. Vishvajitsinh Bhati 55

56. Metallic Surfaces
• Plastic of polyethylene or polyvinyl chloride type are used along
with plasticizer for the coating of metallic surfaces.
• These are used in the protect the metal from corrosion. And it
applied on tanks, vessels, stirrers, fans.
Plastic Cements
• Used in spaces btwn acid resistance tiles and bricks.
Special Cases
• Used as guards for moving parts of machinery. Nylon and PVC
are use for aseptic screening.Vishvajitsinh Bhati 56

57. • we discus types of thermoplastic..
1. Polyolefin's
a) Low density polyethylene [LDP]
b) High density polyethylene [HDP]
c) Poly propylene [PP]
2. Polystyrene
3. Polyvinyl chloride [PVC]
a) Plasticized
b) Unlplastized
4. Polycarbonate
5. Polymethyl - methacrylate [PMMA]
6. Poly amides [NYLONS]
7. Polytetrafluro Ethylene [PTEE]
Vishvajitsinh Bhati 57

58. Overall 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.
Vishvajitsinh Bhati 58

59. Advantages of Plastics
• Unbreakable, tough, flexible, durable.
• Light in weight and easily transported.
• Molded into various shapes and sizes.
• Cheaper.
• Readily and easily manufactured on large scale.
• Pleasant to touch.
• Suck-back feature.
• Odorless.
• Good chemical resistance.
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60. Disadvantages of plastics
• Poor conductor of heat – for heat sterilization.
• Attacked by organic solvents and oils.
• Plastic contains – antioxidant, plasticizer and stabilizer – these
substance can be leached to product preparation.
• Chemical binding adsorption of ingredients [Drugs +Additives]
of product with chemicals of plastic so loss of….
– Preservatives
– Antioxidants
– Flavors
.. and hence loss of stability of product.Vishvajitsinh Bhati 60

61. • Permeability of moisture and gases CO2,O2, known as breathing.
• Chemical reaction of products ingredients with plastic
ingredients.
• Alternation of physical properties of plastic or products.
Drug-Plastic Consideration
In selecting a plastic container consideration must be given to..
• Composition of material
• Its mechanical and chemical properties.
• Its ease of fabrication and printability.
• Requirement of rigidly or flexibility.
• Acceptance of plastic ingredients by F.D.C.
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62. Depending on the type of plastic, the total constituents may include
the following..
• Basic polymer • Lubricants
• Residual monomers • Antioxidants
• Plasticizers
• Accelerators
• Slip or antislip additives
• U.V. absorbers
• Modifiers
• Stabilizers
• Filters
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63. • A packaging system must protected the drug without in any way
alternating the composition of the product until the last dose is
removed.
• Drug-plastic consideration have been divided into five separate
categories.
1. Permeation
2. Leaching
3. Sorption
4. Chemical reaction
5. Alternation in the physical properties of plastic o products
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