Detailed Project Report on i.v. fluid manufacturing unit

I.V. FLUID MANUFACTURING UNIT

[CODE NO.4133] 

Intravenous fluids, also known as intravenous solutions, are supplemental fluids used in intravenous therapy to restore or maintain normal fluid volume and electrolyte balance when the oral route is not possible. 

IV fluids are also known as a saline solution. This sterile solution is made of sodium chloride and water. This liquid is the foundation of every IV solution, providing essential hydration, diluting medications, and facilitating the delivery of vitamins throughout the body.

IV fluids help maintain a patient's hydration, electrolyte and blood sugar levels while undergoing surgical procedures. Clinicians are also able to administer warmed IV fluids directly into a patient's bloodstream, as it is common for a patient's body temperature to decrease slowly while he or she is sedated.

STANDARD IV & ELECTROLITES

- NaCl 0.18 – 2.7%

- Glucose 2.5 - 50%

- Sodium Lactate (Hartmanns’s) Solution

- Ringer Lactate

- Water For injection

- Sterile Water for Irrigation

- Sodium Chloride 0.9% for irrigation

- Sodium Chloride 0.18 – 0.45% and Glucose 4 – 10 %

- Potassium Chloride 0.15 – 0.3% in Sodium Chloride 0.9%

- Potassium Chloride 0.15 – 0.3% in Glucose 5%

The aims of IV fluid administration should be to 

• Avoid dehydration 

• Maintain an effective circulating volume 

• Prevent inadequate tissue perfusion during a period when the patient is unable to achieve these goals through normal oral fluid intake 

“Intravenous fluids have a range of physiologic effects and should be considered to be drugs with indications, dose ranges, cautions, and side effects.”

The intravenous route is the fastest way to deliver medications and fluid replacement throughout the body, because they are introduced directly into the circulation. 

Intravenous therapy may be used for fluid volume replacement, to correct electrolyte imbalances, to deliver medications, and for blood transfusions.

Basic IV Setup

Let's take a look at the most basic possible setup for an IV:

 The drip chamber is located just below the IV bag; inside this chamber we can see the fluid drip down from the bag into the IV tubing. This is where we measure the speed of a manual IV setup; we look at this chamber and count the number of drops we see per minute. So, for example, if we count 25 drops over the period of 60 seconds, we would say that the IV is infusing at a rate of 25 drops per minute, or 25 gtt/min. (In reality, we may not count the number of drops in a full minute; we can, for example, count the number of drops we see over a period of 15 seconds, and then multiply that number by 4 to get the number of drops in a full minute.)

The drip chamber must always be half full. If the drip chamber is too full, we will not be able to see the drops to count them, and so we will be unable to determine the rate at which the IV is infusing. If the drip chamber is not full enough, then this will allow air to get into the IV tubing, which means that air would get into the patient's circulatory system, which could be very dangerous, blocking a blood vessel or stopping the heart.

The roller clamp is what we use to control the rate at which the IV fluid infuses. If we roll it one way, it squeezes the IV tubing more tightly, making it narrower and therefore making the fluid flow through the tubing more slowly; if we roll it the other way, it loosens its pinching of the IV tubing, making the tubing less narrow, and allowing the IV fluid to flow through at a faster rate. So, if for example, we observe (by looking at the drip chamber and counting drops) that an IV is infusing at a rate of 50 gtt/min, but it was ordered to infuse at a rate of 30 gtt/min, we would tighten the roller clamp to slow the drip rate down until we could count only 30 drops going through the drip chamber each minute.

All roller clamps on a set of IV tubing should be closed before we attach a bag of IV fluid to the top of the tubing; this ensures that no air gets into the tubing.

Every IV medication will be ordered to infuse at a specific rate, and one of the major tasks of hosptial nurses is to set up the IV so that it infuses at this rate and to adjust the IV periodically if the rate has changed so that it remmains at the ordered rate. The rate at which an IV fluid infuses is referred to as the IV infusion rate or flow rate.

The slide clamp is used when we want to completely stop the IV from flowing, without having to adjust the roller clamp. This is handy if we want to stop the IV for a moment, but we don't want to have to reset the flow rate by readjusting the roller clamp all over again once we start the IV up again. This works by pinching the tubing completely shut when we slide the tubing into the narrowest part of the clamp.

The injection port is a place where medicine or fluids other than those in the current IV bag can be injected so that they will infuse into the patient's vein through the IV tubing. On the photo above we can see two ports: one on the IV bag itself and one below the drip chamber. There is also usually an injection port close to where the needle goes into the patient's vein; we'll see this below. The injection port on the actual IV bag is used if we want to mix some kind of medication with the fluid that is in the IV bag; if we inject the medication into this port and then roll the bag a little to mix the medication into the fluid in the bag, then the patient will recieve both the medication and the IV fluid at the same time. However, this can only be done when the IV fluid and the medication are allowed to be mixed. If we want to inject medication or a second kind of IV fluid directly so that it does not mix with the IV fluid that we've already attached, then we will use one of the ports that are located below the drip chamber.

COST ESTIMATION

Plant Capacity                                    91200 Nos/Day

Land & Building (4000 sq.mt.)          Rs. 4.15 Cr

Plant & Machinery                               Rs. 6.69 Cr

Working Capital for 1 Month            Rs. 2.60 Cr

Total Capital Investment                     Rs. 14.14 Cr

Rate of Return                                       37%

Break Even Point                                   52%

• INTRODUCTION
• STANDARD IV & ELECTROLITES
• THE AIMS OF IV FLUID ADMINISTRATION SHOULD BE TO
• BASIC IV SETUP
• LET'S TAKE A LOOK AT THE MOST BASIC POSSIBLE SETUP FOR AN IV:
• LOCATION- TENGNOUPAL DISTRICT
• PLANT PROPOSED PLANT LOCATION:-
• MAP
• CLIMATE
• TRANSPORTATION
• BY AIR:
• BY TRAIN:
• BY ROAD:
• DETAILS OF REGISTRATION
• TYPES OF IV FLUIDS
• IV SOLUTIONS CAN ALSO BE CLASSIFIED BASED ON THEIR PURPOSE:
• CRYSTALLOIDS
• GENERAL CHARACTERISTICS OF CRYSTALLOID
• ISOTONIC IV FLUIDS
• 0.9% NACL (NORMAL SALINE SOLUTION, NSS)
• DEXTROSE 5% IN WATER (D5W)
• LACTATED RINGER’S 5% DEXTROSE IN WATER (D5LRS)
• RINGER’S SOLUTION
• HYPOTONIC IV FLUIDS
• 0.45% SODIUM CHLORIDE (0.45% NACL)
• 0.33% SODIUM CHLORIDE (0.33% NACL)
• 0.225% SODIUM CHLORIDE (0.225% NACL)
• 2.5% DEXTROSE IN WATER (D2.5W)
• HYPERTONIC IV FLUIDS
• HYPERTONIC DEXTROSE SOLUTIONS
• DEXTROSE 10% IN WATER (D10W)
• DEXTROSE 20% IN WATER (D20W)
• DEXTROSE 50% IN WATER (D50W)
• NURSING CONSIDERATIONS FOR HYPERTONIC SOLUTIONS
• DARROW’S SOLUTION
• COLLOIDS
• HUMAN ALBUMIN
• DEXTRANS
• LOW-MOLECULAR-WEIGHT DEXTRANS (LMWD)
• HIGH-MOLECULAR-WEIGHT DEXTRANS (HMWD)
• IV FLUID/ELECTROLYTE THERAPY
• NORMAL SALINE
• VOLUME EFFECTS OF NS
• RINGER'S FLUIDS
• ADVANTAGE:
• DEXTROSE SOLUTIONS
• EFFECT OF DEXTROSE IN FLUID:
• VOLUME EFFECTS
• ?5%D
• ? DNS
• 5% DEXTROSE COMPOSITION:
• DEXTROSE SALINE (DNS)
• PHARMACOLOGICAL BASIS
• DEXTROSE WITH HALF STRENGTH SALINE
• 10% DEXTROSE & 25% DEXTROSE
• ISOLYTE G,M,P,E
• PARACETAMOL 10 MG/ML SOLUTION COMPOSITION
• QUALITATIVE AND QUANTITATIVE COMPOSITION
• METRONIDAZOLE IV SOLUTION
• ECONOMIC PROFILE
• MARKET POSITION
• APPLICATION INSIGHTS
• VOLUME INSIGHTS
• INDIA LARGE VOLUME PARENTERAL (LVP) MARKET SHARE INSIGHTS
• BUSINESS JUSTIFICATION
• PRODUCTS
• WHY IV FLUID?
• GLOBAL INTRAVENOUS SOLUTION MARKET: KEY TRENDS
• GLOBAL INTRAVENOUS SOLUTION MARKET: SEGMENTATION
• GLOBAL INTRAVENOUS SOLUTION MARKET: REGIONAL ANALYSIS
• GLOBAL INTRAVENOUS SOLUTION MARKET: COMPETITIVE LANDSCAPE
• MAJOR FIVE IV FLUID MONITORING DEVICES COMPANIES:
• B. BRAUN MELSUNGEN AG
• BAXTER INTERNATIONAL INC.
• BECTON, DICKINSON AND CO.
• FORTIVE CORP
• ICU MEDICAL INC.
• SOURCE OF MACHINES TECHNOLOGY
• USES AND APPLICATION
• SOME GENERAL INTRAVENOUS FLUIDS
• SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS 
• DEXTRAN 40 INJECTIONS
• DEXTROSE INJECTION WHEN DETERMINED BY THE FOLLOWING METHOD:-
• DEXTRAN 110 INJECTIONS
• SODIUM CHLORIDE AND DEXTROSE INJECTION
• 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
• FORM FILL SEAL TECHNOLOGY
• LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
• THE PRODUCTION OF I.V. SOLUTION PRODUCTION LINE CONSISTS 
•    OF 5 MAIN PHASES:
• 1. WATER PURIFYING
• 2. DISTILLATION
• 3. SOLUTION FILLING
• 4. STERILIZATION
• 5. PACKING
• A TYPICAL FFS PROCESS WORKS AS FOLLOWS.
• BASIC OF BFS TECHNOLOGY
• BLOW FILL SEAL EQUIPMENT
• BFS MOLDS AND TOOLING
• BFS TRIALS
• PROCESS
• 1. BLOW MOLDING
• 2. FILLING
• 3. SEALING
• BLOW FILL SEAL MACHINES
• BLOW FILL SEAL IS SUITABLE FOR YOUR APPLICATION:
• ASEPTIC PACKAGING
• BLOW FILL SEAL (BFS) AND FORM FILL SEAL (FFS) TECHNOLOGY
• MANUFACTURING PROCESS OF I.V. FLUID
• 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:-
• PROCESS FLOW DIAGRAM
• FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
• 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
• PLANT LOCATION FACTORS
• PRIMARY FACTORS
• 1. RAW-MATERIAL SUPPLY:
• 2. MARKETS:
• 3. POWER AND FUEL SUPPLY:
• 4. WATER SUPPLY:
• 5. CLIMATE:
• 6. TRANSPORTATION:
• 7. WASTE DISPOSAL:
• 8. LABOR:
• 9. REGULATORY LAWS:
• 10. TAXES:
• 11. SITE CHARACTERISTICS:
• 12. COMMUNITY FACTORS:
• 13. VULNERABILITY TO WARTIME ATTACK:
• 14. FLOOD AND FIRE CONTROL:
• EXPLANATION OF TERMS USED IN THE PROJECT REPORT
• 1. DEPRECIATION:
• 2. FIXED ASSETS:
• 3. WORKING CAPITAL:
• 4. BREAK-EVEN POINT:
• 5. OTHER FIXED EXPENSES:
• 6. MARGIN MONEY:
• 7. TERM LOANS:
• 8. TOTAL LOAD:
• 9. LAND AREA/MAN POWER RATIO:
• PROJECT IMPLEMENTATION SCHEDULES
• INTRODUCTION
• PROJECT HANDLING
• PROJECT SCHEDULING
• PROJECT CONSTRUCTION SCHEDULE
• TIME SCHEDULE
• MACHINERY PHOTOGRAPHS
• MULTIPLE EFFECT WATER DISTILLATION PLANT
• MIXER
• STORAGE VESSEL
• BLOW FILL SEAL MACHINE
• AUTOMATIC BOTTLE LABELLING MACHINES
• RAW MATERIAL SUPPLIER
• SODIUM LACTATE
• NACL
• KCLC ACL2
• PRODUCT PHOTOGRAPHS

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)