I.V. FLUID (BFS TECHNOLOGY) [3569]
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 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. Normal Saline (0.9% NaCl): Isotonic salt water.154 mEq/L Na+; 154 mEq/L Cl-; 308mOsm/L.Cheapest 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 compensate the deficiency of sodium ions when dextrose is injected it gives energy due to glucose content of it when dextro-saline is given in combination, it replanishes 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 that 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 patent (open) for future use. IV fluids come in different forms and 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 the fluid leaves the intravascular space and enters the interstitial and intracellular spaces. Still others are created 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 created 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 is sterile water. Chemically, water is referred to as a “solvent.” A solvent is a substance that dissolves other materials called “solutes.” Within IV solutions, the solutes can be molecules called electrolytes (charged particles such as sodium, potassium, and chloride) and/or other larger compounds such as proteins or 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 42400 Bottle/Day
Land & Building (4000 sq.mt) Rs. 3.30 Cr
Plant & Machinery Rs. 22.29 Cr
Working Capital for 1 Month Rs. 1.13 Cr
Total Capital Investment Rs. 26.92 Cr
Rate of Return 11%
Break Even Point 75%
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
HS 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 INTRAVENOUS SOLUTIONS MARKET
COMPETITIVE LANDSCAPE AND KEY VENDORS
KEY VENDORS IN THIS MARKET ARE -
GROWTH DRIVERS, CHALLENGES, AND 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:
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
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)
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:-
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
BOILER
FILTER PRESS
LABORATORY EQUIPMENTS
MIXER
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA
SUPPLIERS OF COMPLETE PLANT AND MACHINERY
CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT
AND 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)
