I.v. Fluids
INTRODUCTION
Intravenous fluids are fluids which are intended to be administered to a patient intravenously, directly through the circulatory system. These fluids must be sterile to protect patients from injury, and there are a number of different types available for use. Many companies manufacture packaged intravenous fluids, as well as products which can be mixed with sterile water to prepare a solution for intravenous administration.
Fluids are given when someone’s body fluid volume falls. There are a number of things which can cause a drop in fluid volume. Vomiting and diarrhea are a classic example, which is why people are encouraged to drink fluids when they are sick, to keep their fluid volume stable. Another cause is blood loss, which causes problems both because people lose blood products, and because they experience a loss in fluid volume. Electrolyte levels in the blood can also become unstable as a result of rapid changes in fluid volume, in which case intravenous fluids can be used to restore the balance.
Intravenous fluids can be broken into two broad groups. Crystalloids such as saline solutions contain a solution of molecules which can dissolve in water. When crystalloids are administered, they tend to create low osmotic pressure, allowing fluid to move across the blood vessels, and this can be linked with edema. Colloids contain particles which are not soluble in water, and they create high osmotic pressure, attracting fluid into the blood vessels. Blood is an example of a commonly administered intravenous colloid.
In nursing homes and hospital where patients are suffering from acute dehydration or considerable debilitating conditions, the intra venous fluids are used as IV drips. The basic function of IV fluids is to replenish the body fluids. Although there are a number of IV fluids but generally three types of IV fluids are used in hospitals as IV drips. They are as follows:
1. Dextrose injection fluid
2. Dextrose and sodium chloride injection fluid
3. Sodium chloride injection solution (Saline solution).
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 replenishes the dehydration as well as gives energy thereby recouping debility syndrome and also in general take care of malaise.
DEXTROSE
Dextrose (D-glucose, Corn Sugar, Starch Sugar, Blood Sugar, Grape Sugar) is by for the most abundant Sugar in nature and occurs either in the free state (mono saccharine form) or chemically linked with other sugar varieties. In the free state, it occurs in substantial quantities in honey, fruits, and berries. As a polymer of a hydro dextrose units, it occurs in starch, cellulose, and glycogen. Sucrose is a disaccharide of dextrose and fructose. Commercial production of dextrose by hydrolysis of starch yields white crystalline sugars that are either anhydrous (C6H12O6) or hydrated (C6H12O6H2O).
DEXTROSE SOLUTION
Dextrose Solution (5%) is an isotonic solution and supplies calories to human body instantaneously without disturbing the electrolytic balance.
DEXTROSE SALINE INJECTION
The substance Dextrose, known under the synonym anhydrous dextrose, is used in the preparation of Dextrose injection.
The name ‘Dextrose’ is used to preserve a distinction from Glucose syrup, a preparation made by heating starch with water in presence of a small proportion of acid until the hydrolysis has reached a suitable stage. Glucose syrup is very viscous syrup of approximately the following composition: -
Dextrin 40%
Maltose 20%
D-Glucose 20%
Water 20%
It is an important commercial product, and is used (e.g. in the manufacture of sweets) chiefly because of the sticky, gum-like dextrin it contains.
SALINE INJECTION
Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents.
The nominal pH is 5.5 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:
0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride (sodium chloride (sodium chloride injection) injection), USP (NaCl) with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.
0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride (sodium chloride (sodium chloride injection) injection), USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.
Types of Fluids
There are many options while choosing IV fluids:
Glucose Na+ K+ Cl- Lactate Comments (g/L) (mEq/L) (mEq/L) (mEQ/L) (mEq/L)
Normal saline (0.9%) 0 154 0 154 0 maintenance, resuscitation
Half-normal saline (0.45%) 0 77 0 77 0 maintenance
Ringer’s lactate 0 130 4 109 28 3 mEq/L Ca2+ as well
D5W 50 0 0 0 0 maintenance
D5W + 1/2%NS 50 77 77
2/3 + 1/3
normal plasma
USES AND APPLICATION
There are four main ranges of application of highly specialized intravenous infusion solutions:
1. Treatment of discarded water and electrolyte metabolism, especially in severe cases.
2. Therapy of acid base in balances.
3. The volume substitution and volume replacement in surgery of accident victim suffering blood loss.
Paratral nutrition for severally ill and post-operative patients
Grades of Iv Fluids
I.V. fluids or Intravenous fluids are life saving drugs, which are widely used in surgery, pediatrics, urology, obstetrics and gynecology.
I.V. fluids are given mostly to patients suffering from dehydration, diarrhorea, vomiting, gastroenteritis and excessive perspiration.
There are various intravenous transfusion solutions manufactured for use in medicine such as dextrose solutions, sodium chloride solutions, dextrose-sodium chloride combination solutions, multiple electrolyte solutions, diuretic solution, peritoneal dialysis and haemodialysis solutions, amino acid solutions, plasma volume expanders and anticoagulation solutions for collecting blood etc.
Fluids of various grades that can be produced include the following :-
1. Transfusion normal saline IP 540 ml. in glass bottle USP II.
2. Transfusion dextrose 5% IP 540 ml. in glass bottle USP II.
3. Mannitol 20% BP 250 ml.
4. Acid solution A LP 75 ml. in 540 ml. glass bottle.
5. Acid solution B 75 ml. in 375 ml. glass bottle.
6. Injection dextrose 10% IP 540 ml.
7. Injection dextrose 20% IP 540 ml.
8. Metronidizole with 100 ml/500 mg.
9. Metronidizole with 0.5% 100 ml.
10. Dextrose 5% and sodium chloride 0.9% 540 ml.
11. Dinger lactates USP.
12. Elyte-P, Elyte-M and Elyte-G.
13. Elyte I.V. 100 ml.
14. Elgly - D.
15. Water for injection in 10 ml. glass ampoules.
Manufacturing Process
The basic raw materials for the production of IV solutions are water, dextrose, and specific pharmaceutical drugs.
The process of manufacture of Dextrose, sodium chloride and Dextrose sodium chloride fluids consist mainly 3 steps.
I. Distilled Water preparation.
II. Solution making by adding proper quality of ingredients.
III. Automatic Aseptic PVC (Medicinal Grade) Bottle Filling & Sealing.
1. DISTILLED WATER PREPARATION
The water distillation unit is fed with fully dematerialized water, the distillate generally prepared by multiple evaporation and subsequent condensation.
Water for injection is prepared by a simple process called multiple stage evaporation. The raw water is first treated with KMnO4 solution (Wt.% 0.5 - 1.90) in order to remove the odour and microorganism present in the water. Next comes the main step of the process distillation in 3 repeated times.
Distillation in a method of separation of substances which differ appreciably their vapour press is a method of separation. There are various types of distillation methods using different equipments in the pharmaceutical industry. Fractional distillation is highly effective in the point of view of unity of the separated liquid. The raw water heated in the reboiler to get vaporized. This vapor is changed in condenser and transferred to the reboiler of distillation unit. This repeated distillation makes highly pure water.
Water for injection is to be minimum required quantity of pure NaCl is added prior to filling and sealing vessels. Sodium chloride injection water contains (0.9 %) weight per volume of Sodium chloride.
2. SOLUTION PREPARATION
The method used in the preparation of I.V. fluids is the same except little modification in certain basis. In most of the cases the method involves mixing of various ingredients in proper concentration followed by dissolution in pyrogen free distilled water under controlled conditions of temperature, pH particulate matter, pyrogenicity and aseptic environment.
Dextrose 5 % injection contains 540 ml. of I.V. solution with Dextrose 27 gr. in a glass bottle.
Dextrose-Sodium chloride injection contains 540 ml. of fluid with Dextrose 27 gr. and Sodium chloride 4.86 gr. in a glass bottle.
Sodium chloride injection contains 540 ml. of fluid with sodium chloride 4.86 gr. in a glass bottle.
I.V. solution may be of different types as per requirements. The major solutions are as follows.
(a) Common solutions - 5% dextrose
5% dextrose with 0.9% Nacl
(b) High Caloric solution - 10% dextrose
20% dextrose
50% dextrose
16% dextrose with normal salinic (DNS)
(c) Multiple Electrolyte
(d) Renal solution manmtol 10 and 20%
3. FILTRATION AND FILLING
1. Weighing of various ingredients for dissolution.
2. Pyrogen free distilled water is collected in a reactor and weighed ingredients are dissolved in appropriate manner. The mixer is set as per the finished product requirement.
3. The solution from this reactor pumped through serial filtration to retain organism, particulate matter and other carbonaceous matter.
4. The solution is then filled in plastic polyethylene bottles and sealed.
Suppliers of Plant and Machinery
Mr. Yogesh Mehta M/s. YOGESHWAR MACHINERY MFG CO. Address: Shed 2, Bajrang Estate, Nr. Nagarvel Hanuman, Amraiwadi, Ahmedabad-380026, Gujarat (India). Phone: +91- 79 - 65440260 Mobile No.: +91-9376124131 Email: info@stickertechno.com Website: www.stickertechno.com
Mr. Arvind Mewada Mr. Dharampal Singh M/s. Parth Engineers & Consultant Address: Plot No. C-1/4519, Phase - IV, B/h. Indo German Tool Room, G.I.D.C, Vatva, Ahmedabad – 382445, Gujarat, INDIA. Phone : +91-79-25841154, +91-79-25841155 Mobile: +91-9825015826 , +91-9825015825 E-mail : info@parthec.com ,parthec@yahoo.com
The Sonthalia Group Address: CF-255, Salt Lake City, Sector-1, Kolkata - 700 064, India Phone: +(91)-(33)-23218274/23218276/23218316 Fax: +(91)-(33)-23371468/23218421 Website: http://www.sonthaliagroup.com/plastic-products.html
Motive Powers, Inc. Mumbai Address: 24, Whispering Palms Shopping Centre Akruli Road Lokhandwala Township, Kandivli (East), Mumbai - 400 101, India Phone: +(91)-(22)-28852489 Fax: +(91)-(22)-28851324 Website: http://www.indiamart.com/motivepowers
Ionics Environmental Solutions Address: No. 2, 4th Floor, Third Cross Street, V. P Colony, Ayanavaram, Chennai, Tamil Nadu - 600 023, India Phone: +(91)-(44)-65555035/26744500/42726001 Fax: +(91)-(44)-26744500 Mobile / Cell Phone: +(91)-9940477548 Website: http://www.ionicsenviro.com/water-treatment-plant.html
Firetech Boilers Private Limited Address: Firertech House, 211, 38th Main, 2nd Cross, BTM Layout, 2nd Stage, Bangalore- 560 068, India Phone: +(91)-(80)-26683686/51200466 Fax: +(91)-(80)-26683921 Website: http://www.indiamart.com/firetech
Vasu Pumps and Systems Private Limited Address: 1/9 B, Jindal House, Asaf Ali Road, New Delhi - 110 002, India Phone: +(91)-(11)-55358060 Fax: +(91)-(11)-23214651
SUPPLIERS OF RAW MATERIALS
Alice Health Care Private Limited Address: No. C - 44, Industrial Area, Phase - 3, S. A. S. Nagar, Mohali - 160 055, India Phone: +(91)-(172)-4627046 Fax: +(91)-(172)-4627046 Mobile / Cell Phone: +(91)-9356338242 Website: http://www.alicepharmafranchiseindia.com/
Mehta Traders Address: C - 4, Indraloc, Old Nagardas Road, Andheri East, Mumbai - 400 069, India Phone: +(91)-(22)-66991723 Fax: +(91)-(22)-28342934 Mobile / Cell Phone: +(91)-9819608997 Website: http://www.indiamart.com/mehtatraders/
Shiv Corporation Address: No. 1 - F, Vallabh Avenue, Chandravali Char Rasta, Water Tank Road, Karelibaug, Vadodara - 390 018, India Phone: +(91)-(265)-2464127 Mobile / Cell Phone: +(91)-9825107848 Website: http://www.indiamart.com/shiv-corporation/
Brooks Corporation Address: Gr. 24, T V Industrial Estate, 248 Worli Road, S.k Ahire Marg, Mumbai- 400 030, India Phone: +(91)-(22)-24953501/24953499 Fax: +(91)-(22)-24939740 Website: http://www.indiamart.com/brooks-corporation
Chemlon International Address: 215, IInd Floor, DLF Galleria, DLF Phase IV, Gurgaon - 122 009, India Phone: +(91)-(124)-4107580/2574012/4101552 Fax: +(91)-(124)-4054581 Website: http://www.indiamart.com/chemlongroup
PLANT ECONOMICS
Rated Plant capacity = 30000.00 BOTTLES/day
= 9000000.00 BOTTLES/annum
I.V. FLUID (FFS TECHNOLOGY)
NORMAL SALINE, DEXTROSE 5% AND
S C 0.225%), DEXTROSE 10% INJ.
(10% DA), DEXTROSE 5% INJ. (5%
DA), DEXTROSE 5% & SC 0.9% INJ
TOTAL COST OF LAND & BUILDING
1. Land Area Required 5 Acres Rs. 2,20,00,000.00
2. Building Rs. 4,77,50,000.00
TOTAL COST OF PLANT & MACHINERY TOTAL Rs. 7,96,09,909.00
FIXED CAPITAL
1. LAND & BUILDING Rs. 6,97,50,000.00
2. PLANT & MACHINERY Rs. 7,96,09,909.00
3. OTHER FIXED ASSETS Rs. 2,07,50,000.00
TOTAL Rs. 17,01,09,909.00
COST OF RAW MATERIALS
1. NaCl Salt 750 Kgs. Rs. 15,000.00
2. Dextrose 37800 Kgs. Rs. 30,24,000.00
3. PP Resin 45000 Kgs. Rs. 54,00,000.00
4. Laboratory & ETP Chemicals Rs. 50,000.00
5. Printed Packing Materials like label, Sticker etc. for 750000 Nos. Rs. 7,50,000.00
6. Carton Boxes for 24 bottles each 31500 Nos. Rs. 6,30,000.00
7. Consumables Store Rs. 50,000.00
TOTAL Rs. 99,19,000.00
TOTAL WORKING CAPITAL/MONTH
1. RAW MATERIAL Rs. 99,19,000.00
2. SALARY & WAGES Rs. 13,59,600.00
3. UTILITIES & OVERHEADS Rs. 12,35,000.00
TOTAL Rs. 1,25,13,600.00
TOTAL CAPITAL INVESTMENT
TOTAL FIXED CAPITAL Rs. 17,01,09,909.00
TOTAL WORKING CAPITAL FOR 3 MONTHS Rs. 3,75,40,800.00
TOTAL Rs. 20,76,50,709.00
TURN OVER/ANNUM
1. By Sale of 1800000 Bottles 1000 ml each Normal Saline NS Rs. 5,40,00,000.00
2. By Sale of 1800000 Bottles 1000 ml each Dextrose 5% & Sodium Chloride 0.225%. Rs. 5,40,00,000.00
3. By Sale of 1800000 Bottles 1000 ml each Dextrose 10% injection 10% DA Rs. 5,40,00,000.00
4. By Sale of 1800000 Bottles 1000 ml each Dextrose 5% Injection 5% DA Rs. 5,40,00,000.00
5. By Sale of 1800000 Bottles 1000 ml each Dextrose 5% & Sodium Chloride 0.9% Inj. DNS Rs. 5,40,00,000.00
TOTAL Rs. 27,00,00,000.00
PROFIT = RECEIPTS - COST OF PRODUCTION
= 27,00,00,000.00 - 19,01,56,521.43
= 7,98,43,478.57
PROFIT SALES RATIO = Profit / Sales x 100
= 29.57%
RATE OF RETURN = Operating profit / T.C.I x 100
= 38.45%
BREAK EVEN POINT (B.E.P)
FIXED COSTS
B.E.P. = ——————————————— X 100
FIXED COSTS + PROFIT
= 39.65%
