IV FLUID MANUFACTURING PLANT [3532]
Intravenous fluids may be classified into crystalloids, colloids, and blood products (box). Crystalloids are substances that form a true solution and pass freely through a semipermeable membrane. Colloids are substances that do not dissolve into a true solution and do not pass through a semipermeable membrane. The administration of intravenous fluids is one of the most common and universal interventions in medicine. Intravenous fluids can supply two things: fluid volume and electrolytes. These fluids are usually provided to acutely expand intravascular volume, to correct an underlying imbalance in fluids or electrolytes or to compensate for an ongoing problem that is affecting either fluid or electrolytes. Two IV solutions are used for acute volume expansio. They are Normal Saline (0.9%) and Lactated Ringer's Solution. Normal Saline is nothing more than salt water at a concentration that is isotonic with the blood (154 mM sodium). 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.
COST ESTIMATION
Plant Capacity 90000 Bottles/Day
Land & Building (3000 sq.mt) Rs. 2.98 Cr
Plant & Machinery Rs. 5.50 Cr
Working Capital for 1 Month Rs. 2.31 Cr
Total Capital Investment Rs. 11.15 Cr
Rate of Return 43%
Break Even Point 46%
INTRODUCTION
TYPES OF IV FLUID
COMMONLY USED IV FLUIDS
HOW INTRAVENOUS FLUIDS ARE CREATED
INTRAVENOUS FLUIDS
IV FLUID/ELECTROLYTE THERAPY
DEXTROSE
DEXTROSE SALINE INJECTION
PROPERTIES
TABLE I. PHYSICAL PROPERTIES OF D-GLUCOSE
TABLE 2. SOLUBILITY OF DEXTROSE IN WATER
REQUIREMENTS OF RAW MATERIALS
TABLE I REQUIREMENT FOR DEXTROSE MONOHYDRATE
INTERNATIONAL MARKET OVERVIEW
ECONOMIC PROFILE
WORLD MARKET CONSUMPTION
SOURCE OF MACHINES TECHNOLOGY
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
MARKET SURVEY
INDIAN DRUGS AND PHARMACEUTICALS INDUSTRY
INDUSTRY TRENDS
MARKET STRUCTURE
MARKET STRACTURE
INDIAN BULK DRUG MARKET SHARE
ADDITIONAL MARKET POSITION
MAJOR INTERNATIONAL IMPORTING COUNTRIES
MAJOR IMPORTING COUNTRY’S - MENA REGIONAL & GCC
COMPETITION - MAJOR EXPORTING COUNTRIES
COMPETITORS/IV FLUID MANUFACTURERS
INSTALLED CAPACITY, PRODUCTION, CAPACITY UTILIZATION OF IV FLUID
APPERENT CONSUMPTION OF IV FLUID
ESTIMATED DEMAND
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 WATER
FOR INJECTION
HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL
LABELING
IDENTIFICATION
HEAVY METALS
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
1. DISTILLED WATER PREPARATION
2. SOLUTION PREPARATION
3. INJECTION BLOW MOULDING
5. FILLING PROCESS
6. SEALING PROCESS
7. MOULD OPENING PROCESS
FILTRATION AND FILLING
STERILIZATION
QUALITY CONTROL
PREPARATION OF 1 LTR (1000 ML) OF NORMAL SALINE
CALCULATION
PROCEDURE
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
PLANT LAYOUT
SWOT ANALYSIS
SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT
FORM FILL SEAL TECHNOLOGY (FFS)
1. FORM-FILL-SEAL TECHNOLOGY
CALCULATING INTRAVENOUS FLOW RATES
STEP 1 CHOOSE THE FORMULA.
STEP 2 USE THE FORMULA.
STEP 1 CHOOSE THE FORMULA.
STEP 2 USE THE FORMULA.
STEP 1 CHOOSE THE FORMULA.
STEP 2 USE THE FORMULA.
STEP 1 CHOOSE THE FORMULA.
STEP 2 USE THE FORMULA.
LIST OF MACHINERY IV BAG PRODUCTION
FORM FILL AND SEAL MACHINE
IV BAG PRODUCTION (IV PRODUCTION AND PACKING)
IV BAG EMPTY PRODUCTION LINE
1. WATER PURIFYING
2. DISTILLATION
3. SOLUTION FILLING
4. STERILIZATION
5. PACKING
A TYPICAL FFS PROCESS WORKS AS FOLLOWS.
SUPPLIERS OF RAW MATERIALS
POTASSIUM PERMANGANATE
SODIUM CHLORIDE (I.P. GRADE)
DEXTROSE
HDPE ROLL SHEET FOR PACKAGING
STERILIZING EQUIPMENTS
PM METER
LABELING MACHINES
TANKS
BOILERS
FILTER PRESS
LABORATORY EQUIPMENTS
MIXER
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA
COMPLETE PLANT SUPPLIERS
CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT
AND MACHINERY
APPENDIX – A:
01. PLANT ECONOMICS
02. LAND & BUILDING
03. PLANT AND MACHINERY
04. OTHER FIXED ASSESTS
05. FIXED CAPITAL
06. RAW MATERIAL
07. SALARY AND WAGES
08. UTILITIES AND OVERHEADS
09. TOTAL WORKING CAPITAL
10. TOTAL CAPITAL INVESTMENT
11. COST OF PRODUCTION
12. TURN OVER/ANNUM
13. BREAK EVEN POINT
14. RESOURCES FOR FINANCE
15. INSTALMENT PAYABLE IN 5 YEARS
16. DEPRECIATION CHART FOR 5 YEARS
17. PROFIT ANALYSIS FOR 5 YEARS
18. PROJECTED BALANCE SHEET FOR (5 YEARS)
