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Materials of Pharmaceutical Plant Construction

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

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Materials of Pharmaceutical Plant Construction

  1. 1. Pharmaceutical Engineering - 1 Vishvajitsinh Bhati 1
  2. 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. 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. 3Vishvajitsinh Bhati
  4. 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. 4Vishvajitsinh Bhati
  5. 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 5Vishvajitsinh Bhati
  6. 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. 6Vishvajitsinh Bhati
  7. 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. 7Vishvajitsinh Bhati
  8. 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. 8Vishvajitsinh Bhati
  9. 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. 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. 10Vishvajitsinh Bhati
  11. 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. 11Vishvajitsinh Bhati
  12. 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. 12Vishvajitsinh Bhati
  13. 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. 13Vishvajitsinh Bhati
  14. 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.. 14Vishvajitsinh Bhati
  15. 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… 15Vishvajitsinh Bhati
  16. 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. 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 17Vishvajitsinh Bhati
  18. 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. 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 19Vishvajitsinh Bhati
  20. 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. 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. 21Vishvajitsinh Bhati
  22. 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. 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. 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. 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. 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. 27. Non-Ferrous Metals oSilver oNickel oChromium oZirconium oTantalum oPlatinum oCopper oCopper alloys oAluminium oLead oTitanium oTin 27Vishvajitsinh Bhati
  28. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Vishvajitsinh Bhati 59
  60. 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. 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. Vishvajitsinh Bhati 61
  62. 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 Vishvajitsinh Bhati 62
  63. 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 Vishvajitsinh Bhati 63
  64. 64. V i s h v a j i t s i n h B h a t i Vishvajitsinh Bhati 64

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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


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