Detailed Project Report on small i.v. fluid plant

SMALL I.V. FLUID PLANT

[CODE NO.4176] 

Intravenous fluids, in general are used as I.V. drips for patients in nursing homes and hospitals are 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

Commonly used IV Fluids

 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 property 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                                21,200 Bottles/Day

Land & Building (2429 sq.ft.)        Existing

Plant & Machinery                          Rs. 6.70 Cr

Working Capital for 1 Month        Rs. 62 Lac

Total Capital Investment               Rs. 7.84 Cr

Rate of Return                                 35%

Break Even Point                            53%

• 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 1: PHYSICAL PROPERTIES OF D-GLUCOSE
• TABLE 2: SOLUBILITY OF DEXTROSE IN WATER
• REQUIREMENTS OF RAW MATERIALS
• TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE
• ECONOMIC PROFILE
• SOURCE OF MACHINES TECHNOLOGY
• MARKET OVERVIEW OF I.V. FLUID
• SALINE IV SEGMENT IS DOMINATING THE INTRAVENOUS 
• SOLUTIONS MARKET
• OVERVIEW OF INDIAN PHARMACEUTICALS COMPANY
• MARKET SIZE
• EXPORTS
• INVESTMENTS AND RECENT DEVELOPMENTS
• GOVERNMENT INITIATIVES
• USES AND APPLICATIONS
• I.V. FLUID PROCESS AND FORMULATION
• STANDARD IVF & ELECTROLITES
• DIALSYS SOLUTIONS
• TPN (TOTAL PARENTERAL NUTRITION)
• SPECIAL SOLUTIONS
• IV SOLUTIONS: LARGE VOLUME PARENTERALS
• IV SOLUTIONS: SMALL VOLUME PARENTERALS
• SOME GENERAL INTRAVENOUS FLUIDS
• SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS 
• DEXTRAN 40 INJECTIONS
• DEXTRAN 110 INJECTIONS
• B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES
• SODIUM CHLORIDE AND DEXTROSE INJECTION
• 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
• GUIDELINES FOR IV FLUID DISTRIBUTION, STORAGE & ADMINISTRATION
• GUIDELINES FOR ADMINISTRATION OF I. V. FLUIDS INTRODUCTION
• STAFF EDUCATION
• INFECTION CONTROL
• HAND-WASHING
• EXPIRY DATES
• 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
• SUPPLIERS OF POTASSIUM PERMANGANATE
• SUPPLIERS OF SODIUM CHLORIDE (I.P. GRADE)
• SUPPLIERS OF DEXTROSE
• SUPPLIERS OF PLANT AND MACHINERY
• SUPPLIERS OF STERILIZING EQUIPMENTS
• SUPPLIERS OF PM METER
• SUPPLIERS OF LABELING MACHINES
• SUPPLIERS OF TANKS
• SUPPLIERS OF BOILER
• SUPPLIERS OF FILTER PRESS
• SUPPLIERS OF LABORATORY EQUIPMENTS
• SUPPLIERS OF 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
• HELP LIFE CONSULTANTS
• 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)