Detailed Project Report on Glucose & Sodium Chloride Saline

GLUCOSE & SODIUM CHLORIDE SALINE

[EIRI/EDPR/1577] J.C. 296

INTRODUCTION

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

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 de- termines 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            1,00,00,000 Bottles/Day

Land & Building (12,000 sq.mt.)    Rs. 4.17 Cr

Plant & Machinery                    Rs. 8.65 Cr

Working Capital for 2 Months    Rs. 4.36 Cr

Total Capital Investment          Rs. 18.25 Cr

Rate of Return                          51%

Break Even Point                      45%

CONTENTS

INTRODUCTION

KEY TERMS

DEXTROSE

DEXTROSE SALINE INJECTION

PROPERTIES

REQUIREMENTS OF RAW MATERIALS

ABOUT BLOW-FILL-SEAL (BFS) TECHNOLOGY

ECONOMIC PROFILE

WORLD MARKET CONSUMPTION

MEDICAL BLOW-FILL-SEAL

SOURCE OF MACHINES TECHNOLOGY

USES AND APPLICATION

SOME GENERAL INTRAVENOUS FLUIDS

MARKET SURVEY

ADDITIONAL MARKET POSITION

INDIAN PATENTS LAW, TRADE LAW & TAXATION

'TAX'ING INDIAN PHARMA

PRESENT MANUFACTURES OF I.V FLUIDS

SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN  INJECTION

DEXTRAN 110 INJECTION

B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES

SODIUM CHLORIDE AND DEXTROSE INJECTION

WATER THE EXCELLENT SOLVENT USED IN PHARMACY

BASIC RAW MATERIALS

REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS

MANUFACTURING PROCESS OF FFS TECHNOLOGY

ADVANTAGES OF B.F.S. VS. GLASS

"B.F.S." THE BLOW FILL SEAL TECHNOLOGY

MANUFACTURING PROCESS UNDER B.F.S./F.F.S.

SCHEMATIC DIAGRAM OF BFS PRODUCTION PROCESS

FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS

PLANT LAYOUT

SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT

GENERAL PLANT LAYOUT

EFFLUENT TREATMENT AND DISPOSAL

TOLERANCE LIMITS FOR INDUSTRIAL EFFLUENT DISCHARGE

WASTE TREATMENT

TYPICAL WASTE SOLIDS CHARACTERISTICS

SPECIFICATION OF EFFLUENT DISCHARGE OF PHARMACEUTICAL INDUSTRY

MANPOWER

IMPLEMENTATION SCHEDULE

SCHEMATIC DIAGRAM OF PRODUCTION PLANT PROCESS

LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE

CIP SYSTEM

GUIDE TO GOOD MANUFACTURING PRACTICE (GMP) FOR 

MEDICINAL PRODUCT PRINCIPLE

GENERAL

CLEAN ROOM AND CLEAN AIR DEVICE CLASSIFICATION

CLEAN ROOM AND CLEAN AIR DEVICE MONITORING

ISOLATOR TECHNOLOGY

BLOW/FILL/SEAL  TECHNOLOGY

TERMINALLY STERILISED PRODUCTS

ASEPTIC PREPARATION

PERSONNEL

PREMISES

EQUIPMENT

SANITATION

PROCESSING

STERILISATION

STERILISATION BY HEAT

MOIST HEAT

DRY HEAT

STERILISATION BY RADIATION

STERILISATION WITH ETHYLENE OXIDE

FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE 

STERILISED IN THEIR FINAL CONTAINER

FINISHING OF STERILE PRODUCTS

SUPPLIERS OF RAW MATERIALS

EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA

INDUSTRIAL ETP PLANT MANUFACTURE/SUPPLIER

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)