PRIMARY INFORMATION

PROJECT AT A GLANCE

MANUFACTARING OF
LAREGE VOLUME PARENTERAL
IN PLASTIC BOTTLES
(F. F. S. TECHNOLOGY)

Fully Automated F.F.S.

Machine with terminal Sterilization by
Super Heated Water Spray Sterilizer

Prepared by

Thomas C. Cherian M.Sc.

Mob. 8019510855/9949933780
(Approved Mfg. Chemist & Process Consultant
28 years of Experience in Injectable, Projects,
Lic. No. M.C. 1133. Licensed from
Food and Drugs Administration,
Government of M.P., A.P. & W.B. India-
 INTRODUCTION

Congratulations for your decision to start a Pharmaceutical company at Jharkhand.

It is not only an Industry for Business But also a Human Kind Service to get a good
Quality Pharmaceutical Products in and around Jharkhand and Bihar.

I am very much eager to hear your final decision about the Production capacity and
Technology you are deciding.  But my advice is to go for Indian established BFS
Technology first. However, the final decision is up to you. Once it is finalized we can go
ahead with the Project works.

Schedule of Project works are as follows:

1. Finalization of Land by making sure of: Water availability, Quality of water, Pollution
free environment,             Road Access, Electric HT Supply availability, Manpower
availability and drainage for treated waste water.
2. Location sketch of Land and verification of Land Documents.
3. Measurement of Land and NOC from adjacent land owners.
4. Design of Building Layout depends on the technology and capacity by considering the
expansion plan.
5. Project Report and Financial Projections.
6. URS of Machines and Equipment's
7. Approvals from all statutory departments and Bank
8. Selection of necessary Manpower
9. Starting of construction and selection of Machinery's.
10. Purchase orders as per URS to approved selected vendors.
11. Make sure to complete the Building works within 6 months except paneling works
and finishing jobs and erection works starts on 6th month and all commissioning works
should complete by 9th Month. 
12. Set up and completion of Quality Control Lab and Quality Assurance System
13. Recruitment of necessary Manpower, Production, QC, QA and Engineering Heads
and Maintenance Team
14. Documentation works
15. Performance Qualification and Validation of all equipment's start and should
complete within 1 month.
16. Water system Validation, Area Validation, HVAC system Validation and Steam
system Validation completion within 2 months.
17 Application for Licensing (Test License - Stability Study) and get ready for Joint
Inspection
18 Grant of License - 28D
19. Process Validation and Approvals of Protocols, SOPs, Master Formulas and other
Documentations.
20. Commercial Productions.

Approximate 16 Months strict, Pre-Planned, arranged, scheduled works for the successful
commissioning of Project.

I am ready to help at any way for the completion and commissioning of the Project as per
your requirement.
 

Advantages in my Project design

 Low Risk of Cross Contamination

 Less material handling

 Less human interventions

 High level of sterility assurance

 Ease in operation

 Zero leakages

 In situ Cleaning, Sanitation and Sterilization

 Filling range of 100ml, 500ml, and1000ml,

 Total operation in single panel PLC control

 Class 100 filling station and class 10000 adjacent areas

Product Information’s

I.V. Fluids

Intravenous Fluids – Parenteral Drugs, generally called as Saline/ Glucose Injections.

Injections may be classified mainly as five categories

1. Solutions ready for injections

2. Suspension ready for injections
3. Emulsions
4. Soluble products ready for injection by combining with a solvent
5. Dry insoluble products ready to injections with suitable vehicle

Injections may be administered by following routs

Depends upon the nature of the products

1. Intravenous
2. Subcutaneous
3. Intramuscular
4. Intraspinal

At 1657 by Sir Christopher Wren was firstly beginning the injections by vain in living
animals.

The term parenteral came from the Greek word Para enteran means
Beside the intestine refers to the rout of administration of drugs by injection under or
through one or more layer of skin or muscular membrane or vain.
 Developments in I.V. Industry

1. In the later heart of 19th century developed the hot air and steam
Sterilization and the bacteria retaining filter.

2. In 1920 Dr. Florence Seaward provided proof that the chills and fever occurred
during I.V. Fluid administration is due to the presence of waste material of
microorganism (pyrogen) which can eliminate from water by Multy Column
Distillation Process.

3. Discover of High Efficacy Particulate Air (HEPA) Filter and Laminar Air Flow
(LAF) it help for to prevention of Microbial and other contaminations in the product

4. In 1972 Dr. J.F Cooper discover the method of determine the presence of pyrogen
by Limulus Amibocite Lisate (LAL) Test.

5. Technological development in machineries.

Advantages

Immediate Physiological effects will get.

Surgical Medicare
It is useful when the patient is in unconscious state
For Electrolyte imbalance
For nutrition
Industry profile

Purpose of I.V FLUID THERAPY

The basic Purpose of administering I.V. FLUID is to establish and maintain adequate
composition of fluids and Electrolytes in the patients, who suffer from variety of
diseases.

1. To maintain normal body composition when food or fluid intake is impossible.

2. To correct acute or chronic disturbances of fluid and electrolyte balances.
3. Maintenance I.V Therapy for unconscious patient.
4. Patients with cerebral or respiratory disturbances, when there is danger of
aspiration of food.
5. Before and after surgery.

COMMONLY USED I.V.FLUIDS

1. Carbohydrate solutions

2. Sodium Chloride Solutions

3. Electrolytes Solutions

4. Anti bacterial Solutions

5. Antibiotic Solutions

6. Antifungal solutions

7. Dialysis fluids

8. Irrigation Solutions

9. Amino Acid–Transfusions

10. Synthetic plasma volume substitutes (Dextran, Haemaccel, and Icoccel etc.)
PRODUCTS

1. Dextrose injection IP 5% w/v : 500ml1000ml

2. Dextrose injection IP 10% w/v : 100ml/500ml/1000ml

3. Dextrose injection IP 20% w/v : 500ml

4. Invert Sugar injection IP 10% w/v : 500ml

5. Invert Sugar injection IP 5% w/v : 500ml

6. Sodium Chloride inj. IP 0.9%w/v : 100ml/500ml/1000ml

7. Sodium Chloride inj. IP 0.45%w/v : 500ml

8. Sodium Chloride inj. USP 3%w/v : 100ml

9. Sodium Chloride 0.9%w/v and 500ml/1000ml

Dextrose 5% w/v injection IP :

10. Sodium Chloride 0.45%w/v and 500ml/1000ml

Dextrose 2.5% w/v injection IP :

11. Sodium Chloride 0.45%w/v and 500ml

Dextrose 5% w/v injection IP :

12 Compound Sodium : 500ml/1000ml

Lactate injection IP
(Ringer Lactate solution for inj.)

13. Mannitol 20%w/v inj. IP : 100ml

14. Metronidazole injection IP : 100ml

15 Atropine Sulphate injections IP : 100ml

(1mg/ml)

16. Peritoneal dialysis Solution IP : 1000ml/3000ml

(1.7%Intraperitonial dialysis Fluid)

17. Sodium Chloride irrigation Solution IP: 1000ml/3000ml

(Sodium Chloride0.9%w/v in water for inj.)
18. Glycine irrigation Solution IP 1.5%w/v : 1000ml/3000ml

19. Sterile Water for irrigation USP : 1000ml/3000ml

20. Concentrated Hemodialysis solution BP : 5000ml/10000ml

(Concentrated solution with Acetate)

21. Concentrated Hemodialysis solution BP : 5000ml/10000ml

(Concentrated acidic solution)

22. Glucose Intravenous infusion BP 20%w/v : 500ml

(Vet.)

23 Dextrose injection IP 25% w/v : 100ml/500ml

24. Tinidazole 0.2%w/v injection : 200ml

25 Multiple Electrolytes and : 500ml/1000ml

Dextrose injection Type III –I.P

26. Multiple Electrolytes and : 100ml/500ml

Dextrose injection Type I-IP

27. Multiple Electrolytes and : 500ml

Dextrose injection Type IV-I.P

28. Multiple Electrolytes and : 500ml

Dextrose injection Type V-IP

29. Ciprofloxacin injection IP : 100ml

30. Ofloxacin Inj. I.P :100ml

USES

The basic Purpose of administering I.V. FLUID is to establish and maintain adequate
composition of fluids and Electrolytes in the patients, who suffer from variety of
diseases.

 To maintain normal body composition when food or fluid intake is impossible.

 To correct acute or chronic disturbances of fluid and electrolyte balances.

 Maintenance I.V Therapy for unconscious patient.

 Patients with cerebral or respiratory disturbances, when there is danger of

Aspiration of food.

 Before and after surgery.

Process flow chart

Raw water R. O Water

W.F.I D.M

Medicine preparation Raw Materials

Filtration Micro filtration unit

Bottle Blowing Filling and

sealing

Unloading

Sterilization Saturated
ntinued Steam
from from boiler
previous page

Leak test

Physical verification

Visual inspection

Labeling Automated machine

Polythene filling and sealing Flow Wrap machine

Box filling Corrugated boxes

Box Sealing Automated sealing machine

F.G. Stock

F. G. Dispatch