Detailed Project Report on i.v. fluid manufacturing unit

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I.V. FLUID MANUFACTURING UNIT

[CODE NO.4059]

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 fluid therapy is an efficient and effective way of supplying fluids directly into the intravascular fluid compartment, in replacing electrolyte losses, and in administering medications and blood products.

STANDARD IVF & 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 more narrow 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 48,000 Nos/Day

Land & Building (2000 sq.mt.) Rs. 1.68 Cr

Plant & Machinery Rs. 34.64 Cr

Working Capital for 1 Month Rs. 42 Lac

Total Capital Investment Rs. 37.03 Cr

Rate of Return 22%

Break Even Point 62%

INTRODUCTION

STANDARD IVF & ELECTROLITES

THE AIMS OF IV FLUID ADMINISTRATION SHOULD BE TO

BASIC IV SETUP

TYPES OF IV FLUIDS

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 WITH HALF STRENGTH SALINE

ISOLYTE G,M,P,E

PARACETAMOL 10 MG/ML SOLUTION COMPOSITION

METRONIDAZOLE IV SOLUTION

ECONOMIC PROFILE

MARKET SURVEY

APPLICATION INSIGHTS

VOLUME INSIGHTS

INDIA LARGE VOLUME PARENTERAL (LVP) MARKET SHARE INSIGHTS

NORTH AMERICA AT THE FOREFRONT OF THE GLOBAL INTRAVENOUS

(IV) SOLUTION MARKET

AFRICA’S PHARMACEUTICAL MARKET

BUSINESS JUSTIFICATION

PRODUCTS

WHY NIGERIA?

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 INJECTION

DEXTRAN 110 INJECTIONS

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

FORM FILL SEAL TECHNOLOGY

1. FORM-FILL-SEAL TECHNOLOGY:-

1.3. TERMINALLY STERILIZED PRODUCTS.-

1.5 FILTRATION (MEMBRANE):-

1.7. STERILIZATION (BY DRY HEAT):-

LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE

IV BAG PRODUCTION (IV PRODUCTION AND PACKING)

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

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:-

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

RAW MATERIAL SUPPLIER

SODIUM LACTATE

NACL

KCL

CACL2

PRODUCT PHOTOGRAPHS

MACHINERY PHOTOGRAPHS

MULTIPLE EFFECT WATER DISTILLATION PLANT

MIXER

STORAGE VESSEL

BLOW FILL SEAL MACHINE

AUTOMATIC BOTTLE LABELLING MACHINES

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)

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