Detailed Project Report (DPR) on I.V. Fluid Manufacturing Unit [Paracetamol Solution (500 ML), Metronidazole (500 ML), Dextrose 10% & 50% (1000 ML), Normal Saline (1000 ML)] (Capacity: 14400 Numbers per day)

I.V. FLUID MANUFACTURING UNIT [PARACETAMOL SOLUTION (500 ML), METRONIDAZOLE (500 ML), DEXTROSE 10% & 50% (1000 ML), NORMAL SALINE (1000 ML)]

[EIRI/EDPR/4620] J.C.: 2837US$

IV fluids are specially formulated liquids that are injected into a vein to prevent or treat dehydration. They are used in people of all ages who are sick, injured, dehydrated from exercise or heat, or undergoing surgery. Intravenous rehydration is a simple, safe and common procedure with a low risk of complications.

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%

COST ESTIMATION

Plant Capacity            14,400 Nos/Day  

Land & Building (1500 sq.mt.)    US$ 1.31 Lac    

Plant & Machinery                    US$ 6.41 Lac 

Working Capital for 1 Month    US$ 1.45 Lac 

Total Capital Investment          US$ 9.40 Lac 

Rate of Return                          48%

Break Even Point                      57%

CONTENTS

CONTENTS

INTRODUCTION

STANDARD IVF & 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- CHAD (SOUTH AFRICA)

TRANSPORT IN CHAD

RAILWAYS

HIGHWAYS

AIRPORTS

TYPES OF IV FLUIDS

IV SOLUTIONS CAN ALSO BE CLASSIFIED BASED ON THEIR PURPOSE:

CRYSTALLOIDS

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% DEXTROSE COMPOSITION:

DEXTROSE SALINE (DNS)

DEXTROSE WITH HALF STRENGTH SALINE

10% DEXTROSE & 25% DEXTROSE

ISOLYTE G,M,P,E

METRONIDAZOLE IV SOLUTION

ECONOMIC PROFILE

MARKET SURVEY

ABOUT THE MARKET FOR INTRA VENOUS FLUIDS – LARGE VOLUME PARENTERALS:

VERY IMPORTANT:

NORTH AMERICA AT THE FOREFRONT OF THE GLOBAL INTRAVENOUS (IV) SOLUTION MARKET

AFRICA’S PHARMACEUTICAL MARKET

BUSINESS JUSTIFICATION

PRODUCTS

CONCENTRATE PLANT WILL PRODUCE HIGHLY EFFICIENT LIQUID SOLUTIONS FOR MEDICAL USE

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 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

NORMAL SALINE

GLUCOSE

LACTATE RINGER

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

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

MACHINERY PHOTOGRAPHS

MULTIPLE EFFECT WATER DISTILLATION PLANT 

MIXER

STORAGE VESSEL

BLOW FILL SEAL MACHINE

AUTOMATIC BOTTLE LABELLING MACHINES

RAW MATERIAL SUPPLIER

SODIUM LACTATE

NACL

KCL 

CACL2

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)