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Quali. & quan. layout sterile d.f sahil


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Quali. & quan. layout sterile d.f sahil

  1. 1. GUIDED BY: Dr. M. R. PATEL Principale & HOD in pharmaceutics PRESENTEDE BY: SAHILHUSEN I . JETHARA M. PHARM – I (2013-14) ROLL NO. - 02
  2. 2.   Definition of sterile dosage form Type of sterile preparations  PARENTERALS  INTRODUCTION  COMPONETS of PARENTERAL DOSAGE FORMS  QUALITATIVE DEPARTMENTAL LAYOUT  Plant Layout  Diagram of flow material  Typical parenteral plant layout with space requirement  Qualitative Layout Of Parentral Manufacturing (circular flow & parallel flow)  Quntitative Departmental Layout OPTHALMIC PREPARATION  Definition  Types  Requirenments  Simpler Flow Diagram Showing Arrangement Of Different Area   REFERANCES
  3. 3.  “Sterile dosage forms include parenteral (i.e. Solution, suspension etc. ,) , non parenteral (i.e. implant, ophthalmic etc.,) & irrigation preprations dosage forms.” All the dosage forms should meet their standard requirements of purity, identity, sterility and stability.  When the term sterile dosage form is used, intrefers to a product of a general group of pharmaceuticals having in common the characteristic of sterility. i.e. freedom from living micro-organisms.  Sterility is a required characteristic of these pharmaceuticals because of the method, site, or rout of administration.  Sterile products are the dosage form of therapeutic agent that are free from viable micro-organisms.   Sterile - Absolute term as the state of freedom from all viable organism.
  4. 4. (a). Parenteral preparations. Parenterals are divided into two groups. (i). Small volume parenterals (volume less than 100 ml). (ii). Large volume parenterals (volume 100ml or more than 100ml). (b). Ophthalmic preparations. (i). Eye drops (ii). Eye ointments (c). Irrigation solutions. (d). Dialysis solutions & allergenic extracts. (e). Diagnostic agent (f). Surgicals
  6. 6.  Para: Beyond & Enteron: intestine i.e. beside the intestine.  These are preparations given by other than oral routes.  PARENTRAL PRODUCTS are sterile preparations intended to be administered by injection under or through one or more layers of skin or mucous membranes..
  7. 7. 1. Content(Formulations): a. Therapeutic Agents : API b. Vehicle(Solvent): Aq., Water miscible , Non-Aq. c. Additives: Tonicity adjacent Preservative, Antimicrobial etc. 2. Container : Glass, Plastic(Thermoplastic) 3. Closure: Rubber ( Elastomer , Natural)
  8. 8. 1.THE CLEAN UP AREA Clean up area Entrance ENTER ROOM DARK CLEAN ROOM FIRE EXIT WHITE CLEAN ROOM FIRE EXIT 1.Garment ,container and shelving 2.Seating bench 3.Cleanroom computers 4.Vacuum bachout rig 5.CCD cryostat 6.Monochromator 7.Sputter coater 8.Work bench 9.Class 4 laser 10.Work bench 11.Laminar air flow cabinet 12.Granite surface table 13.Work bench 14.Cleanroom table cabinet 15.Cabinet 16.Laminar flow cabinet 17.Cabinet 18.Work bench 19.Work bench 20.Optical allignment rig. 26
  9. 9. QUALITIES OF CLEAN ROOM            The room should undergo 15-20 air changes per hour. HEPA filters are to clean the air entering the room. HEPA filters remove all airborne particles of size 0.3 or larger with an efficiency of 99.97%. Maintaining higher air pressure(+ve pressure) within the critical area to minimize infiltration of airborne contaminants from outside. Care should be taken to ensure that air flows do not distribute particles from a particle-generating person, operation or equipment to a zone of higher product risk. A warning system should be provided to indicate failure in the air supply. Adjacent rooms of different grades should have a pressure differential of 10 - 15 Pascals. Counters in the clean room should be made of stainless steel or other nonporous, easily cleaned material. Walls and floors should be free from cracks or crevices and have rounded corners. If the walls or floors are to be painted, epoxy paint is used. The air flow should move with uniform velocity along parallel lines. The velocity of the air flow is 90 ± 20 ft/m3. Providing temp. & humidity controls appropriate to the product being manufactured.
  11. 11. HEPA filter, Laminar Air Flow, Class 100 Area.DOP test
  13. 13. A. LAMINAR AIR FLOW UNIT HEPA (HIGH EFFICIENCY PARTICULATE AIR filtration) HEPA Filter  HEPA filters are composed of a mat of randomly arranged fibers (polyvinylidene fluoride -PVDF)  Key metrics affecting function are fiber density and diameter, and filter thickness  There are four basic mechanism in which fibrous air filter remove contamination from the air stream. 1. Straining or Sieving 2. Impaction 3. Interception 4. Diffusion
  14. 14. Laminar flow hoods: These are clean air work benches are specially designed to ensure the aseptic preparation of sterile products. Laminar air flow hoods are generally used in conjunction with clean rooms. For laminar air flow work station the air flow rates shall be 0.3 meter per second (vertical) and 0.45 (horizontal)  Introduction of personnel, equipment, and material into the work area provides sources of particulate matter which may contaminate the product.  Very small particles are not heavy enough to settle due only to the force of gravity, but instead are carried and directed by air currents. and if there is turbulent air, particles may be driven into product.  Laminar air flow velocity satisfactorily sweeps the area yet does not create unacceptable turbulence. 
  15. 15. B. FILLING AREA : It is the most critical area in parenteral plant, where the product & sterilized components are exposed to room environment. Therefore these areas are specially constructed, filtered, and maintained to prevent environmental contamination.
  16. 16. Single filling area :EQUIPMENT PREPARATION PRODUCT MATERIAL FILLING AREA GOWNING AREA PERSONAL Multiple use filling Area:Equipment Equipment preparation Filling MATERIAL Filling Product Filling Filling Personal
  17. 17.         PERSONNEL & GOWNING No. of workers should kept to a minimum. Training of personal Personal hygiene:-All employees should be in good health, Subjected to Physical examination, Understood their responsibilities to report own illness like cold, a sore throat, or other infection. Clothing :Uniform is made up of Dacron and Span polyethylene. Hats & masks are sometimes made of special parchment paper. Foot wears -plastic and rubber material.
  18. 18. C. Layout for Terminal Sterilization Terminal Sterilization Clean Filling Area Unidirectional Solution Clean Prep. Area Changing area Clean Zone Equipment & Component prepn Clean Filling Area Area Clean Changing Equipment & Component prepn Area Comp. Entry area Material Entry
  19. 19. 4.THE QUARANTINE AREA Final product is stored in the quarantine area until distributed 5.FINISHING or PACKAGING AREA
  20. 20. FUNCTION Area Square meter Percentage Production 11,094 45.1 Warehouse 7,606 30.9 Administration 1,018 4.1 Utility 1,716 4.1 Quality control 1,716 7.0 Maintenance 1,014 4.5 Employee services 1,014 4.1 39 0.9 24,607 100.0 Security Total Total 150 M2 manufacturing area +100M2 ancillary for SVP or +150 M2 for LVP
  21. 21. PAPER 412/1 M.PHARM-I (2007-08) CHETAN GANDHI
  22. 22. PAPER 412/1 M.PHARM-I (2007-08) CHETAN GANDHI
  23. 23. PERSONNEL  All employees should be • in good health • Subjected to Physical examination • Understood their responsibilities to report own illness like cold, a sore throat, or other infection.  Personnel entering the aseptic areas should be required to follow a definite preparatory procedure.  Uniform is made up of Dacron and Span polyethylene. →hats & masks are sometimes made of special parchment paper.  personnel working in equipment wash rooms, (sterilizing rooms) & packaging areas are normally required to wear clean uniforms daily and to be conscious of cleanliness, but are not required to meet the special requirements for personnel entering the aseptic areas.
  24. 24. TYPE OF PRODUCTION LINE Compounding Unit packaging Container washing Packaging Depyrogenation Filling Terminated sterilization Inspection
  26. 26. INTEGRATED PRODUCTION LINE Container wash Unit packaging Filling Depyrogenation Packaging Inspection
  27. 27. PROCESSING 6 functional areas; 1.Warehousing or Procurement 2.Compounding area 3.Material support area According to flow diagram 4.Aseptic filling area 5.Packaging area Warehousing or Procurement → Compounding area ↓ 6.Quarantine area Material support area → Aseptic filling area ↓ Packaging area ↓ Quarantine area
  28. 28. DIFFERENT TYPE OF PRODUCTION LINE Equip. Prep. Equip. Prep. Filling Material Filling Gowning Personnel Product Material Filling Product Gowning Product Product Equip. Prep. Fig; ASEPTIC FILLING AREA
  29. 29. Filling Material Personnel Equip. Prep. Filling Product Equip. Prep. Gowning Filling Equipment Equip. Prep. Material Material Product Filling Material Material Equip. Prep. Equip. Prep. Material Personnel Equip. Prep.
  30. 30. Anatomy of eye
  31. 31.  Ophthalmics are defined as the dosage forms intended to be administered on to the external surface of the eye (known as topical preparations), inside (known as intraocular preparations) or adjacent to the eye (known as periocular preparations) or those used in combination with ocular appliances. Ophthalmics are used therapeutically or prophylactically.  Therapeutically useful in the treatment of intraocular or surface conditions like conjunctivitis or inflammation, infections of the eye or eyelids etc.  Prophylactically useful in post surgical and post trauma preparations.
  32. 32. 1. Ophthalmic Solutions includes drops and lotions 2. Ophthalmic Suspensions 3. Ophthalmic Ointments 4. Ophthalmic Emulsions 5. Ophthalmic Gels 6. Ophthalmic Gel-forming solutions 7. Ophthalmic Injections 8. Irrigation Solutions (Intraocular) 9. Ocular Inserts 10. Sterile Powders 11. Contact Lenses Care Solutions
  33. 33. TYPES/CLASSES OF OPHTHALMIC DOSAGE FORMS : DOSAGE FORMS 1. Solutions 2. Suspensions 3. Emulsions 4. Ointments 5. Gels 6.Erodible inserts 7. Non-erodible inserts 2009-10 ADVANTAGES -convenience -patient compliance -best of drug with slow dissolution -prolonged release of drug from vehicle. -enhanced pulsed entry. -Flexibility in drug choice -improved drug stability -increased tissue contact time. -inhibition of dilution by tears. -comfortable -less blurred vision than ointment. -effective -flexiblility in drug type & dissolution rate -need only be introduced into eye & not removed. -controlled rate of release -prolonged delivery -flexibility for type of drug selected. -sustained release PAPER 910201/vijay/m.pharm-1/LMCP DISADVANTAGES -rapid corneal elimination. -loss of drug by drainage. No sustained action -drug properties decide performance. -loss of both solution & suspended solid. -patient non compliance. -Blurred vision -possible oil entrapment. -sticking of eyelids. -poor patient compliance -blurred vision -no true sustained effect. -no rate control on diffusion. -matted eyelids after use. --patient discomfort -requires patient insertion -occasional product. -patient discomfort -irritation to eye -tissue fibrosis 35
  34. 34. Clarity Isotonicity pH approximately equal to 7.4 (near to tear fluid) Purity and stability Sterility Viscosity Surface activity Preservation to prevent the growth of microorganisms  Sterile and particle-free.          Iso-osmotic with the lachrymal secretion.  Optimum viscosity
  35. 35. Highest quality When raw material are rendered sterile before manufacturing process,the reactivity of raw material with sterilizing medium must be completely evaluated & sterilization must be validated.  In most sterile dasage form largest proportion is of “water”  For the preparation intended for parenteral administration ,U.S.P. xxii requires the use of →WFI → SWFI → BWFI  All of above are produced by distillation or reverse osmosis & circulation at relatively high temperature up to 800c, or alternatively its disposal at every 24 hrs, in all S.S. equipment of highest attainable , corrosion resistant quality  
  36. 36.              Pharmaceutical dosage forms (Parenteral Preparation) by Kenneth E. Avis, Leon Lachman, Vol-1. Pharmaceutical dosage forms (Parenteral Preparation) by Kenneth E. Avis, Leon Lachman, Vol-2. Drugs & Cosmetics Act 1940. The theory and Industrial pharmacy by Leon Lachman, Third edition Pharmaceutical science by Remington, 20th edition Pharmaceutical process Validation by Loftus & Nash: 29-90. Remington-The science and practice of pharmacy 21st edition volume I Good manufacturing practices for pharmaceuticals-A plan for total quality control.Marcel Dekker Sterile Pharmaceutical Manufacturing by Groves Gisan
  37. 37. Ph. No. :- +918460378336 Address:- 44, Assiyana Society; Dugarvada Road, Taluko & City : Modasa State: Gujarat Country: India Email: BEST OF LUCK TO ALL . . . . . . . . . .