Detailed Project Report on i.v. fluid (manufactured through bfs technology) capacity: 28l units of 500ml, 20l units of 100 ml, 5l units of 1 ltr per month

I.V. FLUID (MANUFACTURED THROUGH BFS TECHNOLOGY) CAPACITY: 28L UNITS OF 500ML, 20L UNITS OF 100 ML, 5L UNITS OF 1 LTR PER MONTH [3596]

Blow Fill and Seal (BFS) technology is mainly used for pharmaceutical solutions. The examples of pharmaceutical solutions that can be packaged are injectable solutions, antibiotics, ophthalmological drops, suspensions, infusion solutions, solutions for dialysis, solutions for irrigation and solutions for hemofiltration. Intravenous 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 replenish the body fluids. Though a number of I.V fluids are available, generally three types of I.V fluids are used in hospitals as I.V drips. They are as follows:- 1. Sodium Chloride injection fluid, 2. Dextrose and Sodium Chloride injection fluid, 3. Dextrose injection 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 in D5W 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 Normal Saline (0.9% NaCl): Isotonic salt water 154 mEq/L Na+; 154 mEq/L Cl-; 308mOsm/L. Economical and most commonly used resuscitative crystalloid. High [Cl-] above the normal serum 103mEq/L imposes on the kidneys an appreciable load of excess Cl- that cannot be rapidly excreted.  When saline is injected intravenously, it compensates the deficiency of sodium ions, when dextrose is  injected  it  gives energy  due to glucose content of it, when dextrose - saline is  given in  combination it replenishes the dehydration as well as  gives energy thereby recouping debility syndrome and also in  general take care of malaise. Intravenous fluids are chemically prepared solutions that are administered to the patient. They are tailored to the body’s needs and used to replace lost fluid and/or aid in the delivery of IV medications. For patients who do not require immediate fluid or drug therapy, the continuous delivery of a small amount of IV fluid can be used to keep a vein patient (open) for future use. IV fluids available in different forms have different impacts on the body. Therefore, it is important to have an understanding of the different types of IV fluids, along with their indications for use. There are several types of IV fluids that have different effects on the body. Some IV fluids are designed to stay in the intravascular space (intra, within; vascular, blood vessels) to increase the intravascular volume, or volume of circulating blood.  Other IV fluids are specifically designed so that fluid leaves the intravascular space and enters the interstitial and intracellular spaces. Still others are formulated to distribute evenly between the intravascular, interstitial, and cellular spaces. The properties that an IV solution has within the body depends on how it is formulated and the specific materials it contains. It also determines the best type of IV solution to use in relation to the patient’s needs. The majority of an IV solution are prepared with sterile water. Chemically, water is referred to as a “solvent.” A solvent is a substance that dissolves other materials referred as “solutes.” within IV preparations, the solutes can be molecules called electrolytes (charged particles such as sodium, potassium and chloride) and/or other larger compounds such as proteins or other molecules. Today, a growing number of pharmaceutical manufacturers are using advanced aseptic processing technologies to minimize operator intervention and contamination risk in the filling and packaging of liquid parenteral drugs. One of these technologies is form-fill-seal (FFS), in which a polymeric material is formed and sealed inline to a container of choice, while the container is being filled. FFS offers cost savings over conventional aseptic processing in glass. Traditional parenteral filling and packaging requires 23 steps and individual machines for filling, stoppering and capping. In contrast, FFS requires one piece of automated machinery, and takes place in six seconds or less. The entire FFS process is performed under a class-100 laminar flow, preventing external contamination. The fully automatic, computer-controlled technology allows for filling and packaging of up to 3,00,000 bottles of IV fluid per day. Nitrogen purging options are available for sensitive formulations such as amino acids

COST ESTIMATION

Plant Capacity                            212000 Bottles/Day  
Land & Building (5 Acre)          Rs. 8.66 Cr
Plant & Machinery                      Rs. 44.25 Cr
Working Capital for 1 Month    Rs. 5.93 Cr
Total Capital Investment          Rs. 59.76 Cr
Rate of Return                           25%
Break Even Point                      40%

INTRODUCTION    
TYPES OF IV FLUID    
COMMONLY USED IV FLUIDS    
HOW INTRAVENOUS FLUIDS ARE CREATED    
IV FLUID/ELECTROLYTE THERAPY    
KEY TERMS    
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    
EXPORT OPPORTUNITY OF INTRAVENOUS SOLUTION    
LOCAL MANUFACTURING ACTIVITIES    
HSN CODES    
WORLD MARKET TRENDS IMPORTS & EXPORTS    
MAJOR INTERNATIONAL IMPORTING COUNTRIES    
MAJOR IMPORTING COUNTRIES - MENA REGIONAL & GCC    
COMPETITION - MAJOR EXPORTING COUNTRIES    
ESTIMATE OF IMPORTER’S LANDED COSTS    
ECONOMIC PROFILE    
WORLD MARKET CONSUMPTION    
SOURCE OF MACHINES TECHNOLOGY    
GLOBAL MARKET OVERVIEW OF IV FLUID    
GEOGRAPHICAL SEGMENTATION OF THE IV SOLUTIONS MARKET    
COMPETITIVE LANDSCAPE AND KEY VENDORS    
KEY VENDORS IN THIS MARKET ARE     
GROWTH DRIVERS, CHALLENGES & UPCOMING TRENDS:HOME TREATMENT    
USES AND APPLICATION    
SOME GENERAL INTRAVENOUS 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    
IDENTIFICATION    
ASSAY:    
COMPOSITION OF RINGER LACTATE (RL)    
COMPOSITION OF D5 OR D5 W    
COMPOSITION OF METRONIDAZOLE I.V. FLUID    
COMPOSITION OF PARACETAMOL I.V. FLUID    
COMPOSITION OF MANNITOL I.V. FLUID (10%)    
COMPOSITION OF NORMAL SALINE (NS)    
COMPOSITION OF ½ NS (NORMAL SALINE]    
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    
BASIS OF BFS TECHNOLOGY    
BLOW FILL SEAL (BFS) AND FORM FILL SEAL (FFS) TECHNOLOGY    
CONCEPT OF BFS    
MANUFACTURING PROCESS OF I.V. FLUID (FFS TECHNOLOGY)    
A TYPICAL FFS PROCESS WORKS AS FOLLOWS:    
PROCESS FLOW DIAGRAM    
PROCESS IN DETAILS    
1. DISTILLED WATER PREPARATION    
2. SOLUTION PREPARATION    
3. INJECTION BLOW MOULDING    
4. MOULDING PROCESS    
5. FILLING PROCESS    
6. SEALING PROCESS    
7. MOULD OPENING PROCESS    
FILTRATION AND FILLING: -    
STERILIZATION: -    
QUALITY CONTROL: -    
THE WHOLE PROCESS CONSISTS OF THE FOLLOWING STEPS    
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS    
SWOT ANALYSIS    
FORM FILL SEAL TECHNOLOGY    
1. FORM-FILL-SEAL TECHNOLOGY: -    
1.5 FILTRATION (MEMBRANE):-    
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    
SUPPLIERS OF PLANT AND MACHINERY    
STERILIZING EQUIPMENTS    
PM METER    
LABELING MACHINES    
TANKS    
BOILERS    
FILTER PRESS    
LABORATORY EQUIPMENTS    
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA    
SUPPLIERS OF COMPLETE PLANT AND MACHINERY    
CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT & MACHINERY
CLEAN ROOM SUPPLIERS    
MACHINERY CATALOG    


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)