Detailed Project Report on iv fluid manufacturing plant

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)