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Preparation of

Oral Re-
hydration Salt
CONTENTS
01 02 03
Introduction Literature Review Materials and
Method

04 05
Result and Discussion Conclusion
Introduction

Oral re-hydration salt (ORS) are used to treat dehydration caused by diarrhea, a common illness in
travelers. Unlike other fluids, the ratio of the ingredients in an ORS matches what the body needs to
recover from a diarrheal illness.
• Scientists working at the Cholera Research Laboratory, Dhaka, and the Infectious Diseases Hospital,
Calcutta, contributed to the development of modern oral re-hydration salt (ORS) solution. The efficacy of
standard ORS was first demonstrated by Pierce et al and others during 1965-69.
• Oral re-hydration salt (ORS) was established as the cornerstone of therapy for dehydration secondary to
acute infectious diarrhea approximately 40 years ago. The efficacy of ORS is based on the ability of
glucose to stimulate Na and fluid absorption in the small intestine via a cyclic AMP-independent process.
• ORS consists of 4 constituents: 1. sodium chloride, 3.5 grams; 2.trisodium citrate, dihydrate, 2.9 grams;
3. potassium chloride, 1.5 grams; 4. glucose, 20,0 grams; these are to be dissolved in 1 liter of clean
drinking water.
• ORS is of Synthetic origin and belongs to Salts. It belongs to Nutrients and Vitamins pharmacological
group on the basis of mechanism of action and also classified in Electrolyte Oral pharmacological group.
• Use of oral re-hydration therapy has been estimated to decrease the risk of death from diarrhea by up to
93%.
Literature Review

Sr. Year Author Journal Key Points


No

1 2014 CC Unger, SS Archives of Diseas in Treating diarrhoeal diseas in children under five
Salam, R Black childhood years

2 2018 L J Smit, L Silver JOR Spine Advancing cell therapies for intervertabral disc
man, D Sakai regeneration from the lab to clinic

3 2006 GT Keusch, O Diseas Control Diarrheal diseases - The normal intestinal tract
Fontaine, A priorities in regulates the absorption and secretion of
Bhargava developing countries electrolytes.
Materials and Methods

Method
Materials:  Milling
 Sodium Chloride  Drying
 Potassium Chloride  Shifting
 Blending
 Sodium Citrate
 Granuals Quarantine Bulk
 Dextros Anhydrous

Here some excipients


 Sodium Saccharine
 Orange Flavour
Process of Manufacturing

1. Operation of Cadmill :
Check the cadmill bears, Switch on the main switch, check the direction of rotar, check the
pulley belt for required speed.
Mill the Oversize materials throgh cadmill using 1.0 mm SS Sieve at fast speed and knife
forward setting check sieve integrity of cadmill sieve after and before shift the milled material
through 30# SS Sieve using shifter collect the shifted material in cleaned SS container.

Ingerdients Milling Time Sieve Integrity Qty. (in KG.)


(Before and After
Use)

Sodium Saccharine 10 Mins. Ok 2.750


Potassium Chloride 25 Mins. Ok 166.146
Process of Manufacturing (Contnd..)

2. Operation of Fluid Bed Dryer (“FBD”)


Switch on the bag lifting, Switch on the temperature controller and timer and temperature indicator.
Set the inlet temperature.
Load the mterial in the FBD bowl and place the bowl in FBD.
Switch on the lifting to lift the container.
Open the butterfly valve completely and check the fluidization of product in the container.
shake the bag periodically to achieve proper fluidization and uniform drying.
After Completion of cycle unload the product container and wheel out the trolley check the loss on
drying of dried granules.
Transfer the Material for further processing.
Raw Material input and Procesing time
Ingredients Standard Qty. Temperature Drying Time
Inlet Outlet
Dextrose Anhydrus 1526.022 60.0 49.8 70 Mins.
Sodium Chloride 288.190 100.0 71.9 20 Mins.
Potassium Chloride 166.146 100.0 71.6 15 Mins.
Sodium Citrate 319.192 100.0 72.2 20 Mins.
Sodium Sccharine 2.750 60.0 NA 10 Mins.
Quantity Verfication after drying raw material

Sr.No Ingredients Qty.(in KG) Net Weight


1 Sodium Chloride 287.3 287.3
2 Potassium Chloride 165.1 165.1
3 Sodium Citrate 318.2 318.2
4 Dextrose Anhydrous 1520.9 1520.9
5 Sodium Saccharine 2.74 2.74
Process of Manufacturing (Contnd..)

3. Operation of Vibro shifter


Check the vibro shifter’s cleaness and assemble the vibro shifter with required size SS
Sieve. Ensure the locking of sieve. SS Sieve integrity shall be checked to be used.
Arrange properly on the vibro shifter basement and collecting chamber and sieve and
gasket.
Fit the holding rings to hold togather shifting chamber and various gaskets as per assembly
and tighten holding clamps. Supply the power machine , set the container containing
material to be shifted to vibro shifter.
Note: Excessive feeding of material may lead to choking of the vibro shifter and hinder
shifting process.
Note: Shift the following materials using spacified mesh Sieves check the sieve integrety
before and after use.
Material Sieve Integrity Mesh Quantity Shifting time
(Before and Afetr
Use)
Dextose Anhydrous Ok 30 321.9 10 Mins.
Sodium Chloride Ok 30 287.3 14 Mins.
Dextose Anhydrous Ok 30 334.4 13 Mins.
Potassium Chloride Ok 30 165.1 10 Mins.

Dextose Anhydrous Ok 30 329.8 14 Mins.


Sodium Citrate Ok 30 318.2 12 Mins.
Sodium Sacchrine Ok 60 2.74 11 Mins.
Flavour Orange Ok 60 7.70 12 Mins.
Dextose Anhydrous Ok 30 534.8 22 Mins.
Process of Manufacturing (Contnd..)

4. Operation of Shifter and Octagonal Blender with Vaccum Transfer System


Check the Shifter and Octagonal Blender with Vaccum System is cleaned.
Fix theBottom Hopper , Top Hopper with Sieve, Top lead with Clamp and assure that gasket is in its
place.
Feed the one and of hose pipe with clamp to vaccum pump and another end to the vaccum nozzle
of blender.
Fit the one end of another hose pipe to the charging nozzle of blender and another end is to the
discharge nozzle of shifter with clamp.
Fit the end of hose pipe to the top lead of the shifter another end of the hose pipe to the container.
Set the purging valve on auto mode.
Once shifting of material is complete stop the vaccum pump and release the pressure. Switch off
shifter.
Dismental hose pipe of Octagonal Blender shifter and vaccum pump.
Close the lead of blender and assure that gasket in its place. Fix the safety gaurd at the proper
place turn on main switch and turn the blender on blening mode.
Premix A
Mix Preshifted Sodium Sccharine with Pre Shifted dextrose anhydrous about 10 kg manually in
polybag for five minutes call this process Premix A.

Materials Quantity (in KG) Blending Time


Sodium Sachharine 2.740
5 Mins.
Dextrose Anhydrouse 10.0

Premix B
Mix Preshifted Flavours with 10 kgs. of pre-shifted dextrose anhydrous manually in poly
bagfor 5 mins call this process Premix B
Materials Quantity (in Kgs) Blending Time
Orange Flavour 7.70
5 Mins
Dextrose Anhydrous 10.0
5. Blending Process

Material Quanity (in Kg) Loading time


Dextrose Anhydrous 301.9 10 Mins.
Sodium Chloride 287.3 12 Mins.
Dextrose Anhydrous 334.4 13 Mins.
Potassium Chloride 165.1 9 Mins.
Dextrose Anhydrous 329.8 14 Mins.
Premix A
30.44 5 Mins
Premix B
Dextrose Anhydrous 330.9 9 Mins.
Sodium Citrate 318.2 11 Mins.
Dextrose Anhydrous 203.9 11 Mins.

Blending Details
Blend the loade raw materials for 60 Mins in an Octagonal Blender.
06 RPM in octagonal Blender.
6. Quarantine Bulk
Container No. Net Weight (in Kg)
1 361.9
2 350.1
3 358.6
4 360.2
5 359.6
6 358.9
7 151.7

Blend Reconciliation
No of Containers = 7
Standard Yeild 98%
Theoritical weight of granules 2310.0 Kgs
Actual Weight of Granules 2301.0 Kgs
Yeild = 99.61%
Result and Discussion & Conclusion

• During Manufacturing Procedure we not found any major


machine problem and any incident or deviation.
• During this procedure we get ORS Bulk of 2301.0 Kgs.
• The Same bulk is passed on to Filling department for Sachet
Filling Activity. ORS will be filled in the pack of 21 Gms. sachet
each.
• In 21 Gms. 1 Sachet
Sodium Chloride 2.6 Gms.
Potassium Chloride 1.5 Gms
Sodium Citrate 2.9 Gms.
Dextrose Anhydrouse 13.5 Gms.
Excipients QS (Quality Satisfaction)
THANK YOU
FOR YOUR ATTENTION

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