SYRINGE AND CATHETER

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Disposable Syringe is an instrument which is used for injecting any liquid into the body of human beings or of animals. It consists of a cylinder and an air tight piston. These syringes are used for injecting the medicine into the body or into the nerve of the body which are not possible to take in through mouth or takes much time in mixing with blood.

These syringes are available in sizes varying from 2 C.C. to 100 C.C. Most popular and commonly used sizes are 2 C.C., and 5 C.C. Other sizes are also frequently used but upto lesser extent.

In this project, we are manufacturing the disposable syringes with the sizes are 3 ml, 5 ml, 10 ml. 20 ml. and 50 ml.

Previously glass was used for making these syringes; the most commonly used glass is Pyrex glass. This glass is shock-resistant, temperature-resistant and has low thermal co-efficient of expansion. But with the development of plastic technology, this glass has been substituted by high grade plastics. Plastic can be used in place of glass for making syringes without any problem.

Plastic syringes are becoming more popular in the medical world due to its lower cost and higher accuracy. To test the efficiency of a syringe, close the tip with a finger and attempt to withdraw the plunger or piston. If the plunger and barrel fit perfectly, the vacuum created in the cylinder will prevent withdrawal of the plunger. The plunger should not be pulled to return rapidly due to the vacuum created or the barrel may be cracked.

With the development of pharmaceutical industries the use of syringes has also developed. About 70% pharmaceutical industries are in small scale sector. The output of the small scale sector covers a wide spectrum of formulations, which includes antibiotics vitamins, anti T.B. drugs, antidysentery drugs, anti-rheumatics, haematinies, hormonal preparations, tranquilizers, analgesics and anti-phyreties. Indeed this is a very wider range of product mix. About 50 percent of the above listed drugs are injectable and for that purpose syringes are required.

Disposable Syringes are being used by doctors to inject medicines through intravenous or intramuscular ways for the treatment of diseases & also by research & development personnel. Disposable syringes are made of plastic material and are used in the field of medical and veterinary science. Due to their availability in sterilized condition, ready to use, and cost effectiveness, disposable syringes are fast replacing the age-old glass syringes. Moreover, the horror of AIDS worldwide has almost dispensed with the reuse of syringes and the demand of disposable syringes has increased phenomenally. Disposable syringes are mostly injection moulded from polypropylene. Syringes are available in sizes of 1 ml, 2 ml, 5 ml and 10 ml, 50ml in a variety of designs and consist of either two or three components construction. The number and size of injection moulding machines required depend upon syringe construction, number of mould cavities, annual production.

Disposable Syringes made of plastic Material have been successfully used in medical and pharmaceutical practice for many years. The constantly increasing use of this type Syringe indicates its importance. Which is based mainly on the advantages it offers regarding cost and hygienic applications.

The manufacture of plastic syringes has been developed to such a degree that the products now satisfy the requirements and standards set by Hospital and physicians. At the same time they offer the best possible technique of application to the physician and the highest possible degree of safety to the patient.

A catheter is a flexible tube made of latex, silicone, or Teflon that can be inserted into the body creating a channel for the passage of fluid or the entry of a medical device. For many years, the epidermal catheters used were plain tubes made of available industrial compounds, and design was largely based on current need. In the 1950s and early 1960s, a very common practice was to cut a suitable length of industrial polyvinyl chloride (PVC) or nylon tubing and have it sterilized with the other surgical equipment. Nowadays, there are many specialized catheter designs. For example, specific catheter designs allow catheters to be used in pulmonary, cardiac (vascular), neonatal, central nervous system, and epidural tissues. Catheters are designed to perform tissue ablation (tissue removal) and even serve as conduits for thermal, optics, and various medical devices.

The three major types of catheters are coronary, renal, and infusion. Coronary catheters are used for angiography (x-ray of blood vessels after injection of radiopaque substance), angioplasty (altering the structure of a vessel), and ultrasound procedures in the heart or in peripheral veins and arteries. The best-known renal catheters are Foley catheters, which have been commercially available since the 1930s. These catheters are equipped with an inflatable balloon at the tip and are used for urine incontinence, dying patients, and bladder drainage following surgery or an incapacitating injury or illness. The Foley catheter is relatively easy to use and used throughout the world in hospitals, nursing homes, and home-care settings.

Catheters are flexible, hollow tubes which allow blood to flow in and out of your body. They are most commonly used as a temporary access for up to three weeks. This is often done when a patient needs dialysis immediately and is waiting for a fistula or graft to mature. They are also used when a permanent access fails and a patient is too unstable to delay treatment. Several different types of catheters exist. Or we can say that a catheter is a tube put into the body, usually by a medical person, to let fluids drain out. It is often used when the person cannot urinate, as during and right after surgery.

It can also be used to drain pus or blood out of a wound. It is very bad to reuse one as it can have germs on it from the first use. It must be inserted in a very sanitary method so as not to introduce germs into the person. Many folks that have illnesses that makes it difficult to urinate must have them in all the time and sometimes get urinary tract infections if they are not changed often and in a safe manner.

• Catheter refers to a central venous catheter (CVC) or a central line.

• Hub refers to the end of the CVC that connects to the blood lines or cap.

• Cap refers to a device that screws on to and occludes the hub.

• Limb refers to the catheter portion that extends from the patient’s body to the hub.

• Blood lines refer to the arterial and venous ends of the extracorporeal circuit that connect the patient’s catheter to the dialyzer.

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Description

INTRODUCTION
HISTORY:
CATHETER LENGTH, SIZES & TYPES
CATHETER LENGTH
CATHETER SIZE
GENERAL:
BALLOON SIZE
TYPES
DIAMETERS:
STRAIGHT-SINGLE USE CATHETERS
2-WAY FOLEY CATHETERS (RETENTION CATHETERS)
CURVED OR COUDE
3-WAY FOLEY CATHETER
TYPES OF CATHETER
CHARACTERISTICS OF SYRINGES
PARTS OF A SYRINGE
TYPES OF SYRINGE TIPS
1. LUER-LOK TIP
2. PLAIN (SLIP) TIP
TYPES OF SYRINGES
HYPODERMIC NEEDLES
TYPES OF HYPODERMIC NEEDLES
BEVEL
GAUGE
COMMON GAUGES
DISPOSAL OR REUSABLE
USES AND APPLICATION OF SYRINGE
1. USED FOR EXTRACTION OF BLOOD:
2. USED FOR VACCINATION:
3. USED FOR INJECTING OF INSULIN:
4. USED FOR ADMINISTERING ANAESTHESIA:
BRIEF DISCRIPTION OF CATHETER
DIALYSIS CATHETER
THE LINE CAN BE USED FOR:
PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
TUNNELED CATHETERS
UROLOGY CATHETER
CENTRAL VENOUS CATHETER
CATHETER MATERIALS
RAW MATERIALS
SILICONES
POLYVINYL CHLORIDE
LATEX RUBBER
CHEMICAL COMPOSITION OF LATEX
B.I.S. SPECIFICATION
USES, ADVANTAGE, DISADVANTAGE OF CATHETER
ADVANTAGES OF CVC FOR DIALYSIS:
SHORT TERM OPEN ENDED CATHETER
PERIPHERALLY INSERTED CENTRAL CATHETER
TUNNELED CATHETERS
IMPLANTABLE VENOUS ACCESS DEVICES
CENTRAL VENOUS CATHETER
TYPES OF CENTRAL VENOUS CATHETERS
THE TYPE OF CVC INSERTED DEPENDS ON THE:
CENTER VENOUS CATHETERS: OPEN-ENDED OR CLOSED-ENDED
OPEN–ENDED
CLOSED-ENDED
SHORT-TERM CATHETERS
IMPLANTABLE VENOUS ACCESS DEVICE (IVAD)
APPLICATION OF CATHETER
PACKING
PROCESS FLOW CHART FOR DISPOSABLE SYRINGE
MANUFACTURING PROCESS OF DISPOSABLE SYRINGE
LIST OF RAW MATERIAL
MANUFACTURING PROCESS AND SOURCE OF TECHNOLOGY
PP SYRINGES ARE MADE OF:
INSPECTION AND TESTING
FREEDOM FROM PYROGENIC MATERIAL
TEST FOR ABNORMAL TOXICITY
FREEDOM FROM EXTRANEOUS MATTER
LIMIT FOR EXTRACTABLE MATTER
GENERAL
LIMIT OF ACIDITY AND ALKALINITY
LIMIT FOR EXTRACTABLE MATERIAL
LUBRICANTS
NOZZLE
GRADUATION POSITION OF SCALE NUMBERING
FLANGE OF BARREL OR FINGER GRIPS
PISTON
DEAD SPACE VOLUM
MAXMUM DEAD SPACE
LEAKAGE TEST
LEAKAGE TEST BETWEEN BARREL AND PISTON
LEAKAGE TESTING
ACCEPTANCE CRITERIA
PROCEDURE
ACCEPTANCE CRITERIA
THE TEST SHALL BE FOLLOWED AS BELOW:
STERILITY
MARKING OF UNIT CONTAINER
MARKING OF UNIT CONTAINER:
MARKING OF OUTER CONTAINERS:
PACKING:
OUTER CONTAINER
MARKET OVERVIEW OF SYRINGE
MARKET OVERVIW OF CATHETER
MANUFACTURING PROCESS OF CATHETER
PROCESS FLOW DIAGRAM
PHOTOGRAPHS
MELT PUMPS
MELT PUMPS WITH MULTI-LAYER DIE
OPEN CALIBRATION TANK
BALLOON FORMING MACHINE
DUAL FLUTING AND WRAPPING MACHINE
TWO-LAYER HIGH-PRECISION STRAND LINE
WINDER, HAUL-OFF WITH DIAMETER CONTROL & VACUUM CALIBRATION
DIE & CARRIAGE, PREHEATING SYSTEM & UNWINDER FOR SUPPORTING WIRE
CONTROL SYSTEM
PRINCIPLE INFECTION SYSTEM
CATHETER DESIGN AND MATERIALS
MATERIAL DIFFERENCES
CATHETER DESIGN
TIP DESIGN
CATHETER OVER NEEDLE DEVICES
CATHETER THROUGH NEEDLE/CANNULA
NEEDLE DESIGN
CATHETER SIZE
MULTILUMEN CATHETERS
HUB OPTIMIZATION AND INTEGRATION OF HIGH-PERFORMANCE
CATHETERS
TUBING ASSEMBLY
HUB-CATHETER
STANDARD HUB SPECIFICATIONS
BOND STRENGTH
HUB DESIGN AND MANUFACTURING OPTIMIZATION
CATHETER DESIGN AND MANUFACTURE
STEPS OF CATHETER MANUFACTURE
A METHOD FOR FORMING A CATHETER COMPRISING THE STEPS OF:
EXTRUSION, BALLOONS AND CATHETER FINISHING
BRAID TO COIL DELIVERY SYSTEM
FOLEY CATHETER AND ITS MANUFACTURE
A FOLEY CATHETER
LIST OF EQUIPMENT FOR CATHETER
MAIN COMPONENTS OF A CATHETER EXTRUSION LINE
EXTRUDER
MELT PUMPS
GRAVIMETRIC FEEDING
DIES
VACUUM CALIBRATION AND COOLING
DIAMETER CONTROL
HAUL-OFFS
WINDERS
CUTTING UNITS
UNWINDER FOR SUPPORTING WIRE
PREHEATING SYSTEMS
PROCESS CONTROL WITH PROTOCOL LING
CLEAN-ROOM CONDITIONS
TWO-LAYER HIGH-PRECISION STRAND LINE
CONTROL SYSTEM
PLANT LAYOUT
SUPPLIERS FOR MACHINERY FOR CATHETER
SUPPLIERS FOR MACHINERY FOR SYRINGE
MANUFACTURERS/SUPPLIERS OF DISPOSABLE SYRINGE (INDIAN)
COMPLETE PLANT SUPPLIERS FOR DISPOSABLE SYRINGES
SUPPLIERS OF RAW MATERIALS
POLYPROPYLENE GRANULES
SUPPLIERS OF THERMOPLASTIC ELASTOMER
SUPPLIERS OF ETHYLENE OXIDE
SUPPLIERS OF PRINTING INK
SUPPLIERS OF PACKING PAPER
SUPPLIERS OF PACKING BOXES
SUPPLIERS OF PACKING MATERIALS
DISPOSABLE NEEDLE
SUPPLIERS OF DISPOSABLE SYRINGE GASKET
SUPPLIERS OF PLANT AND EQUIPMENTS FOR DISPOSABLE
SYRINGE/TURNKEY CONSULTANTS
SUPPLIERS OF INJECTION MOLDING MACHINE
SUPPLIERS OF SCREEN PRINTING MACHINE
SUPPLIERS OF STERILIZING MACHINE
SUPPLIERS OF AUTOMATIC BLISTER PACKING MACHINE
SUPPLIERS OF EOT CRANE
SUPPLIERS OF POWER TRANSFORMER
SUPPLIERS OF ELECTRICAL PANEL
SUPPLIERS OF COOLING TOWER
SUPPLIERS OF EFFLUENT TREATMENT PLANT (ETP PLANT)
SUPPLIERS OF AIR POLLUTION CONTROL EQUIPMENTS
SUPPLIERS OF AIR CONDITIONING EQUIPMENTS
SUPPLIERS OF AIR COMPRESSORS
SUPPLIERS OF PLATFORM WEIGHING MACHINE
SUPPLIERS OF MATERIAL HANDLING EQUIPMENTS
SUPPLIERS OF FIRE FIGHTING EQUIPMENTS
SUPPLIERS OF SUBMERSIBLE WATER PUMP

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)

Additional information

Plant Capacity

100000 Nos/Day

Land & Building

(5000 sq.mt.)

Plant & Machinery

US$.1230000

Rate of Return

37%

Break Even Point

38%