Detailed Project Report on disposable syringe manufacturing

DISPOSABLE SYRINGE MANUFACTURING [3531]

Disposable Plastic 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, 5ml and 10ml, 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. These are made of plastic material have been successfully used in the 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 the hospitals and physicians. At the same time they offer the best possible technique of applications to the physician and highest possible degree of safety to the patient. Disposable needle is widely used by doctors for injection purpose with the help of syringes. With the increase in population in our country, requirement of medicine and injections has increased. For more strength of people more number of needles are required with syringes. Tablets or capsules also pay a great role in the life of human beings but injections are also a must to some extent. For quick relief, needles are used by surgeons, dental surgeons, Veterinary Surgeons and by the breeders in the poultry farm, where the farm birds are periodically injected against epidemics. During epidemics for better control, disposable needles are of much use. Veterinary Surgeons and doctors find it more useful to use needles as tablets or syrup shall not be helpful. To avoid wastage and to reduce cost by quantity of syrup, needles find a wide scope with the veterinary surgeons/doctors. With the development of pharmaceutical industries the use of syringes and disposable needles will also develop. About 70% pharmaceutical industries are in small scale sector.  The output of small scale sector covers a wide spectrum, anti T.B. Drugs, ant dysentery drugs, unit rhenemsties, haematirines, hormonal preparations, tranquilizers, analagesties and anti-Ryrities. Disposable needles are becoming more popular in the medical world due to its lower cost and higher accuracy. Plastic can be used in place of metal without any problem. The procedure is also relatively easy and cheaper. Only one disadvantage is that there is not so much heat resistance as compared to hypodermic needle.   Even then the disposable needle has widely replaced hypodermic needle because of lower cost, easy compatibility and higher sterilizations. Whenever a suture is required to close a wound. needles to arm the suture material are necessary. The number of sizes and the variety of different shapes of needles run into many thousands. The range supplied by manufacturers is usually classified into types for specific surgery, as for example. arterial. general purpose. intestinal. obstetric ophthalmic. plastic. retention. Shapes are designated as straight, curved, 1/2 circle, 5/8 circle etc. and the sections as round bodied, triangular cutting edge, triangular reverse cutting point, tracer point. In addition the length of the needle from point to hilt is specified  in millimeters and the hilts are designed to take  the various diameters of suture material employed. Needles are chosen by the surgeon to suit his operating technique and it is  largely because  of the surgeons interest in improving suture  efficiency that the development of surgical needles has taken place. In very many cases the surgeon himself has caused needles to be made to his own design and a large number of commonly used needles are referred to by the name of the inventing surgeon. Surgical needles are of two types : those which have an  eye through  which the suture is threaded and eyeless  needles  where the suture is inserted into the hollow hilt and held in  position by  swaging the metal around it. The first patent on an eyeless needle was obtained by the late Sir Henry Souttar in 1921. but in the U.K. their use has only increased appreciably in the past few years. In the U.S.A. 70 percent of the suture needles are of the cycle’s type. The needles themselves are made either of stainless steel or of  carbon  steel,  the latter usually  being  plated  to  resist corrosion.  At  one  time the carbon steel needle  had  a  better resistance to bending than its counterpart in stainless steel but recent  technological  advance  hare is  proved  stainless  steel  needles  and they now compete in strength with carbon  steel  and have  added  advantage  that they will not  corrode  and  do  not present  the  surgeon  with the dreaded emergency  of  having  to locate  and  extract  the  broken  point  of  a  needle  embedded somewhere in the tissues of an unfortunate patient.

COST ESTIMATION

Plant Capacity                                         30000 Nos/Day  
Land & Building (1000 sq.mt)             Rented
Plant & Machinery                                  Rs. 1 Cr
Working Capital for 1 Month                Rs. 11.30 Cr
Total Capital Investment                      Rs. 1.20 Cr
Rate of Return                                       33%
Break Even Point                                    64%


INTRODUCTION    
DISPOSABLE SYRINGE    
DISPOSABLE NEEDLE    
USES AND APPLICATION    
B.I.S. SPECIFICATION    
MARKET POSITION    
60% OF SYRINGES IN INDIA UNSAFE STUDY    
EXIM SCENARIO IN INDIAN SYRINGES AND NEEDLES MARKET    
PRODUCTION OF SYRINGES AND NEEDLES    
APPROACHING AD SYRINGES    
THE DEMAND    
THE BIG PROBLEM    
NEW KIDS    
THE UNEXPLORED TERRITORY    
STATE WATCH    
CHINA IS HERE TOO!    
TACKLING COST ISSUES    
NEED A DESPERATE CHANGE    
NEED FOR EDUCATION    
INTO THE FUTURE    
MARKET SURVEY (GLOBAL)    
INDUSTRY INSIGHTS    
U.S. DISPOSABLE SYRINGES MARKET SHARE, BY TYPE,
    2013 - 2024 (USD MILLION)    
PRODUCT INSIGHTS    
APPLICATION INSIGHTS    
REGIONAL INSIGHTS    
COMPETITIVE INSIGHTS    
BASIS AND PRESUMPTION    
MANUFACTURERS/SUPPLIERS OF DISPOSABLE SYRINGE    
PROPERTIES    
SHAPE AND DIMENSIONS OF NEEDLE    
UNION BETWEEN THE HUB AND THE NEEDLE    
SAMPLING PROCEDURE AND CRITERIA FOR CONFORMITY    
SAMPLE SIZE AND CRITERIA FOR CONFORMITY    
DISPOSABLE SYRINGE TECHNCAL ANALYSIS    
PRODUCTS    
MATERIAL    
STANDARDS (IN ACCORDANCE WITH ISO7886)    
STERILIZATION    
INDIVIDUAL PACKAGE    
LABELING    
ADVANTAGE OF I KM DISPOSABLE SYRINGE    
STEPS IN DISPOSABLE SYRINGE MANUFACTURE    
MANUFACTURING PROCESS    
FREEDOM FROM PYROGENIC MATERIAL    
TEST FOR ABNORMAL TOXICITY    
FREEDOM FROM EXTRANEOUS MATTER    
LIMIT FOR EXTRACTABLE MATTER    
LIMIT OF ACIDITY AND ALKALINITY    
LIMIT FOR EXTRACTABLE MATERIAL    
LUBRICANTS    
SIZE AND DIMENSION OF THE SYRINGE    
NOZZLE    
GRADUATION POSITION OF SCALE NUMBERING    
FLANGE OF BARREL OR FINGER GRIPS    
PISTON    
DEAD SPACE VOLUME    
MAXMUM DEAD SPACE    
LEAKAGE TEST    
LEAKAGE TEST BETWEEN BARREL AND PISTON    
STERILITY”    
PACKING    
OUTER CONTAINER    
MARKING OF CONTAINER    
MARKING OF OUTER CONTAINERS    
LEAKAGE TESTING    
ACCEPTANCE CRITERIA    
PROCEDURE    
ACCEPTANCE CRITERIA    
THE TEST SHALL BE FOLLOWED AS BELOW    
PROCESS FLOW DIAGRAM OF DISPOSABLE PLASTIC SYRINGE    
DETAILS OF PLASTIC PART PROCESSING AND STERILIZATION    
GASEOUS STERILIZATIONS WITH ETHYLENE OXIDE    
MIXTURES    
FACTORS INFLUENCING ETHYLENE OXIDE STERILIZATION    
TEMPERATURE    
CONCENTRATION    
MOISTURE    
STERILIZATION CONCEPTS    
TEST FOR STERILITY    
CAUTION    
MEDIUM FOR AEROBIC ORGANISM    
MEDIUM FOR AEROBIC ORGANISM    
METHOD    
PLANT LAYOUT    
SUPPLIERS OF RAW MATERIALS    
POLYPROPYLENE    
SUPPLIERS OF STAMPINGS    
SUPPLIERS OF ETHYLENE OXIDE    
SUPPLIERS OF PACKING PAPER    
SUPPLIERS OF PACKING BOXES    
SUPPLIERS OF PVC PLASTICS    
NEEDLE    
SUPPLIERS OF PLANT & MACHINERY    
MOULDING MACHINE    
SUPPLIERS OF PRINTING MACHINE    
SUPPLIERS OF STERILIZING PLANT    
SUPPLIERS OF PACKAGING MACHINE    
SUPPLIERS OF WEIGHING MACHINE    
SUPPLIERS OF INJECTION MOULDING MACHINE FOR DISPOSABLE
PLASTIC SYRINGE    
SUPPLIERS OF PLANT AND EQUIPMENTS    
FOR DISPOSABLE SYRINGE/TURNKEY CONSULTANTS    
SUPPLIERS OF MOULDS FOR DISPOSABLE SYRINGE    
SOURCE OF TECHNOLOGY    

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)