Detailed Project Report on syringe and catheter

SYRINGE AND CATHETER

[CODE NO.4198] 

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.

COST ESTIMATION

Plant Capacity                                   100000 Nos/Day

Land & Building (5000 sq.mt.)  Rs. 17.75 Cr

Plant & Machinery                             Rs. 8.61 Cr

Working Capital for 1 Month           Rs. 17.41 Cr

Total Capital Investment                  Rs. 44.43 Cr

Rate of Return                                    37%

Break Even Point                               38%

• 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)