DEXTROSE SALINE (I.V. FLUID) (FFS TECHNOLOGY) (Cap: 60,000 Bottles/Day)
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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.
IVF can supply 3 things: fluid, electrolytes, & calories. In the non stressed, fasting state, the 150g per day inD5W at 125ml/h can provide enough carbohydrate to limit proteolysis. The most common uses for IVF: Acutely expand intravascular volume in hypovolemic states correct electrolyte imbalances Maintain basal hydration
INTRODUCTION
INTRAVENOUS FLUIDS
IV FLUID/ELECTROLYTE THERAPY
KEY TERMS
DEXTROSE
DEXTROSE SALINE INJECTION
PROPERTIES
REQUIREMENTS OF RAW MATERIALS
EXPORT OPPORTUNITY OF INTRAVENOUS SOLUTION
INTERNATIONAL MARKET OVERVIEW
ECONOMIC PROFILE
WORLD MARKET CONSUMPTION
SOURCE OF MACHINES TECHNOLOGY
OVERVIEW OF THE GLOBAL INTRAVENOUS SOLUTIONS MARKET
IV FLUID PRODUCTION CAPACITY AND MARKET DEMAND IN AFGHANISTAN
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
MARKET SURVEY
MARKET STRACTURE
INDIAN BULK DRUG MARKET SHARE
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 40 INJECTION
DEXTRAN 110 INJECTIONS
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
COMPOSITION OF IV FLUID
COMPOSITION OF COMMON IV FLUID (MEQ/L)
COMPOSITION OF IV FLUIDS
COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE
MANUFACTURING PROCESS OF I.V. FLUID (FFS TECHNOLOGY)
PROCESS FLOW DIAGRAM
PROCESS IN DETAILS
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
PLANT LAYOUT
SWOT ANALYSIS
SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT
FORM FILL SEAL TECHNOLOGY
CALCULATING INTRAVENOUS FLOW RATES
GENERAL PLANT LAYOUT
MANPOWER
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
CIP SYSTEM
GUIDE TO GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCT PRINCIPLE
CLEAN ROOM AND CLEAN AIR DEVICE CLASSIFICATION
CLEAN ROOM AND CLEAN AIR DEVICE MONITORING
ISOLATOR TECHNOLOGY
TERMINALLY STERILISED PRODUCTS
ASEPTIC PREPARATION
PERSONNEL
PREMISES
EQUIPMENT
SANITATION
PROCESSING
STERILISATION
STERILISATION BY HEAT
MOIST 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
COMPLETE PLANT SUPPLIERS
SUPPLIERS OF PLANT AND MACHINEY
CONSULTANT OF TURNKEY PROJECT SUPPLIER
OF THE PLANT AND MACHINERY
CLEAN ROOM SUPPLIERS
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