Detailed Project Report on dextrose saline (i.v.fluid) (40000 bottles/day)

 
DEXTROSE SALINE (I.V. FLUID)
(Capacity: 40,000 Bottles/Day of 100 Ml & 500 Ml)

 [CODE NO.1930]


         Intra venous fluids, in general are used as I.V drips for patients in nursing homes and hospitals suffering from acute dehydration or considerable debilitating conditions.  These I.V fluids replanish the body fluids. Though a number of I.V fluids are there, generally three types of I.V fluids are used in hospitals as I.V drips. They are as follows:-

  1. Dextrose injection fluid

  2. Dextrose  and sodium chloride injection fluid


Types of IV Fluid

Crystalloid: Balanced salt/electrolyte solution; for msa true solution and is capable of passing through semi permeable membranes. May be isotonic, hypertonic or hypotonic. Normal Saline (0.9% NaCl), Lactated Ringer’s, Hypertonic saline (3, 5, & 7.5%), Ringer’s solution. However, hypertonic solutions are considered plasma expanders as they act to increase the circulatory volume via movement of intracellular and interstitial water into the intravascular space.


Colloid: High-molecular-weight solutions, draw fluid into intravascular compartment via on cotic pressure (pressure exerted by plasma proteins not capable of passing through membranes on capillary walls).Plasma expanders, as they are composed of macromolecules, and are retained in the intravascular space.

    Free H2O solutions: provide water that is not bound by macromolecules or organelles, free to passthrough.D5W (5% dextrose in water), D10W, D20W, D50W, and Dextrose/crystalloid mixes. Blood products: whole blood, packed RBCs, FFP, Cryoprecipitate, platelets, albumin. Essentially all colloids.


COST ESTIMATION

Plant Capacity                                    40000.00 BOTTLES/day     
Land & Building (6000 Sq.Mtr)            Rs. 2.57  Cr  
Plant & Machinery                                 Rs. 4.50  Cr     
W.C. for 2 Months                                 Rs. 1.48  Cr
Total Capital Investment                      Rs. 8.72  Cr          
Rate of Return                                       37%  
Break Even Point                                  48%

•    INTRODUCTION    
•    KEY TERMS    
•    DEXTROSE    
•    DEXTROSE SALINE INJECTION    
•    PROPERTIES    
•    REQUIREMENTS OF RAW MATERIALS    
•    ABOUT BLOW-FILL-SEAL (BFS) TECHNOLOGY    
•    ECONOMIC PROFILE    
•    WORLD MARKET CONSUMPTION    
•    MEDICAL BLOW-FILL-SEAL    
•    SOURCE OF MACHINES TECHNOLOGY    
•    USES AND APPLICATION    
•    SOME GENERAL INTRAVENOUS FLUIDS    
•    MARKET SURVEY    
•    ADDITIONAL MARKET POSITION    
•    INDIAN PATENTS LAW, TRADE LAW & TAXATION    
•    'TAX'ING INDIAN PHARMA    
•    PRESENT MANUFACTURES OF I.V FLUIDS    
•    SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN  INJECTION    
•    DEXTRAN 110 INJECTION    
•    B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES    
•    SODIUM CHLORIDE AND DEXTROSE INJECTION    
•    WATER THE EXCELLENT SOLVENT USED IN PHARMACY    
•    BASIC RAW MATERIALS    
•    REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS    
•    MANUFACTURING PROCESS OF FFS TECHNOLOGY    
•    ADVANTAGES OF B.F.S. VS. GLASS    
•    "B.F.S." THE BLOW FILL SEAL TECHNOLOGY    
•    MANUFACTURING PROCESS UNDER B.F.S./F.F.S.    
•    SCHEMATIC DIAGRAM OF BFS PRODUCTION PROCESS    
•    FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
•    PLANT LAYOUT
•    SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT    
•    GENERAL PLANT LAYOUT    
•    EFFLUENT TREATMENT AND DISPOSAL    
•    TOLERANCE LIMITS FOR INDUSTRIAL EFFLUENT DISCHARGE    
•    WASTE TREATMENT    
•    TYPICAL WASTE SOLIDS CHARACTERISTICS    
•    SPECIFICATION OF EFFLUENT DISCHARGE OF PHARMACEUTICAL INDUSTRY    
•    MANPOWER    
•    IMPLEMENTATION SCHEDULE    
•    SCHEMATIC DIAGRAM OF PRODUCTION PLANT PROCESS    
•    LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
•    CIP SYSTEM    
•    GUIDE TO GOOD MANUFACTURING PRACTICE (GMP) FOR
    MEDICINAL PRODUCT PRINCIPLE    
•    GENERAL    
•    CLEAN ROOM AND CLEAN AIR DEVICE CLASSIFICATION    
•    CLEAN ROOM AND CLEAN AIR DEVICE MONITORING    
•    ISOLATOR TECHNOLOGY    
•    BLOW/FILL/SEAL  TECHNOLOGY    
•    TERMINALLY STERILISED PRODUCTS    
•    ASEPTIC PREPARATION    
•    PERSONNEL    
•    PREMISES    
•    EQUIPMENT    
•    SANITATION    
•    PROCESSING    
•    STERILISATION    
•    STERILISATION BY HEAT    
•    MOIST HEAT    
•    DRY HEAT    
•    STERILISATION BY RADIATION    
•    STERILISATION WITH ETHYLENE OXIDE    
•    FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE
    STERILISED IN THEIR FINAL CONTAINER    
•    FINISHING OF STERILE PRODUCTS    
•    SUPPLIERS OF RAW MATERIALS    
•    EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA    
•    INDUSTRIAL ETP PLANT MANUFACTURE/SUPPLIER    

APPENDIX – A :

 1.      COST OF PLANT ECONOMICS      
 2.      LAND & BUILDING                                      
 3.      PLANT AND MACHINERY                                  
 4.      FIXED CAPITAL INVESTMENT                             
 5.      RAW MATERIAL                                         
 6.      SALARY AND WAGES                                     
 7.      UTILITIES AND OVERHEADS                              
 8.      TOTAL WORKING CAPITAL                                
 9.      COST OF PRODUCTION                                   
10.      PROFITABILITY ANALYSIS                               
11.      BREAK EVEN POINT                                     
12.      RESOURCES OF FINANCE                           
13.      INTEREST CHART                                       
14.      DEPRECIATION CHART                                   
15.      CASH FLOW STATEMENT                                   
16.      PROJECTED BALANCE SHEET