Detailed Project Report on i.v. fluid (ffs technology)

I.V. FLUID (FFS TECHNOLOGY) [3550]

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. How Intravenous Fluids are created. 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. Three key concepts in consideration of fluid and Three key concepts in consideration of fluid and electrolyte management: electrolyte management: Cell membrane permeability cell membrane permeability, Osmolarity osmolarity, Electroneutrality electroneutrality. Cell membrane permeability refers to the ability of a Cell membrane permeability refers to the ability of a cell membrane to allow certain substances such as cell membrane to allow certain substances such as water and urea to pass freely, while charged ions water and urea to pass freely, while charged ions such as sodium cannot cross the membrane and are such as sodium cannot cross the membrane and are trapped on one side of it. Trapped on one side of it. Osmolarity Osmolarity is a property of particles in solution. is a property of particles in solution. If a substance can dissociate in solution, it may substance can dissociate in solution, it may contribute more than one equivalent to the contribute more than one equivalent to the osmolarity osmolarity of the solution. of the solution. For instance, For instance, NaCl will dissociate into two dissociate into two osmotically osmotically active ions: Na and active ions: Na and Cl. One millimolar millimolar NaCl yields a 2 yields a 2 milliosmolar milliosmolar solution. Electroneutrality Electroneutrality means that the overall number of means that the overall number of positive and negative charges balances. positive and negative charges balances. For instance, in conditions like renal tubular acidosis instance, in conditions like renal tubular acidosis where HCO3 where HCO3-is lost, chloride is retained leading to a is lost, chloride is retained leading to a hyperchloremic hyperchloremic state. Expected Expected osmolarity osmolarity of plasma can be calculated of plasma can be calculated according to the following formula: according to the following formula: Osmolarity Osmolarity (mOsm/kg) = 2 /kg) = 2×[mEq/L N [mEq/L Na+] + glucose+ BUN ] + glucose+ BUN. Concentration of sodium is the major determinant. Concentration of sodium is the major determinant. Normal serum Normal serum osmolarity osmolarity ranges from about 280 to ranges from about 280 to 295 mOsm/kg. Maintenance fluids must be determined for basic Maintenance fluids must be determined for basic requirements, then existing volume or electrolyte requirements, then existing volume or electrolyte deficits must be evaluated to determine the deficits must be evaluated to determine the appropriate IV fluid to use and the volume to appropriate IV fluid to use and the volume to administer.

COST ESTIMATION

Plant Capacity                                                120000 Bottle/Day  
Land & Building (8000 sq.mt)                    Rs. 5.65 Cr
Plant & Machinery                                         Rs. 25 Cr
Working Capital for 2 Months                    Rs. 6.31 Cr
Total Capital Investment                            Rs. 37.44 Cr
Rate of Return                                             38%
Break Even Point                                        46%



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)