Detailed Project Report on sterilization & packaging unit of latex gloves

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STERILIZATION & PACKAGING UNIT OF LATEX GLOVES

[CODE NO.3950]

Gloves are single-use items and should not be washed or reused. Polythene: Thin and have a tendency to tear. They are not an appropriate choice for healthcare settings. Vinyl: Have been shown to be less effective than latex gloves in providing an impermeable barrier against microorganisms.

Disposable medical gloves are available in nitrile, latex and vinyl materials. Any gloves worn by health professionals should be free of powder, sterile, textured and coated for extra protection. Nitrile tends to be the most favored glove material for those working in the healthcare industry.

A disposable glove is commonly made from natural or synthetic rubber that covers the whole hand and is used to protect the wearer against harmful environmental influences and/ or used by caregivers in health care to protect themselves and patients from infections. As the name implies, disposable gloves are designed for single use only and should be disposed immediately after use.

Sterilization:

It is a process by which an article, surface or medium is made free of all microorganisms either in vegetative or spore form. Ethylene oxide gas is commonly used to sterilize objects sensitive to temperatures greater than 60 °C and / or radiation such as plastics, optics and electrics. It can kill all known viruses, bacteria and fungi, including bacterial spores and is compatible with most materials (e.g. of medical devices), even when repeatedly applied. However, it is highly flammable, toxic and carcinogenic.

A typical process consists of a preconditioning phase, the actual sterilization run and a period of post-sterilization aeration to remove toxic residues, such as ethylene oxide residues.

COST ESTIMATION

Plant Capacity : 80000 Pcs/day

Land & Building (600 Sq.MT) : Rs. 44.99 Lacs

Plant & Machinery : Rs. 38.60 Lacs

Working Capital for 1 Month : Rs. 50.76 Lacs

Total Capital Investment : Rs. 1.43 Cr

Rate of Return : 54%

Break Even Point : 40%

INTRODUCTION

STERILIZATION:

HAND PROTECTION- ONE OF PPE’S

CHOICE OF GLOVES

PROJECT LOCATION-VADODARA

MAP OF DISTRICT

TRANSPORT

AIR

RAILWAY

ECONOMY

BRIEF HISTORY OF RUBBER

JOSEPH LISTER AND SURGICAL ASEPSIS

THE HISTORY OF DISPOSABLE GLOVES

1889

1894

1965

1992

MID-1990S

TODAY

TYPES OF DISPOSABLE GLOVES EXIST

USES & APPLICATION OF THIN NITRILE GLOVES

1) MEDICAL GLOVES

THE BASIC ELEMENTS OF EN455 ARE:

2) INDUSTRIAL, LABORATORY AND PHARMACEUTICAL GLOVES

3), WITH A CATEGORY 2 GLOVE WHICH DOES NOT FALL INTO THE CATEGORIES 1 OR 3.

MECHANICAL PROPERTIES

MECHANICAL PROPERTIES OF RUBBER LATEX GLOVE FILM AFTER DIPPING MOLD

TYPES OF GLOVES

GLOVE TYPES THE RUBBER GLOVES CAN BE DIVIDED BASICALLY INTO

4 DIFFERENT CATEGORIES,

MEDICAL GLOVES

MEDICAL GLOVES CAN FURTHER BE DIVIDED INTO TWO,

HOUSEHOLD GLOVES

INDUSTRIAL GLOVES

SPECIALITY GLOVES

EMERGENCY SERVICES

POLICE GLOVES

GLOVE PROPERTIES

THE PERFORMANCE REQUIREMENTS OF GLOVES ARE,

AFTER TREATMENTS OF GLOVES

CHLORINATION

POLYMER COATING

HYDROGEL COATINGS

LATEX IS KNOWN TO CAUSE TWO TYPES OF HYPERSENSITIVITY:

TYPE I ALLERGY

TYPE IV ALLERGY

"SAFE" PROTEIN LEVELS

POWDER-FREE GLOVES

TESTING AND QUALITY CONTROL OF GLOVES

IN-PROCESS TESTING

DIPPED LATEX PRODUCTS

WET-COACERVANT DIPPING

DRY-COACERVANT DIPPING ( COAGULANT DIPPING )

EXAMPLES OF DRY COACERVANT SOLUTIONS ARE GIVEN BELOW: PARTS

BY WEIGHT (PBW)

HEAT SENSITIZED DIPPING

ELECTRO DEPOSITION

FORMERS

DIPPING TANKS

DIPPING MACHINES

SEQUENCE OF OPERATIONS

GLOVE PRODUCTION & MANUFACTURING

THE GLOVES ARE MANUFACTURED BY EITHER A

BATCH DIPPING PROCESS

CONTINUOUS DIPPING PROCESS

LATEX DIPPING

LATEX CONCENTRATE

COMPOUNDING

COAGULANT DIPPING

LATEX DIPPING

BEADING

LEACHING

VULCANIZATION

POST LEACHING

SLURRY DIP

BEADING

LEACHING

VULCANIZATION

POST LEACHING

SLURRY DIP

STRIPPING

TUMBLING

GLOVE PACKING

GLOVE STERILIZATION

FINISHED GLOVES

ETHYLENE OXIDE STERILIZATION PROCESS

SIMPLE BUT EFFECTIVE

A SIMPLE EO PROCESS IN DETAIL

1. ENVIRONMENTAL PRECONDITIONING

ITEMS FOR CONSIDERATION:

2. INITIAL EVACUATION

TODAY, THE TWO MOST COMMON METHODS OF ACCOMPLISHING

THIS REQUIREMENT ARE

ITEMS FOR CONSIDERATION:

3. HUMIDIFICATION

4. GAS INJECTIONS AND GAS DWELL

ITEMS FOR CONSIDERATION:

5. POSTEXPOSURE GAS PURGE AND AIR INBLEED

6. HEATED AERATION

LATEX COMPOUND DESIGN FOR DIPPED GOODS

POLYMER:

FILLERS:

SOFTENERS:

STABILISERS:

ANTIOXIDANTS:

VISCOSITY MODIFIERS:

OTHER ADDITIVES

BRIEF ABOUT VULCANIZATION & ACCELERATORS

ACCELERATORS:

RAW MATERIAL

EXAMINATION GLOVES USED IN HEALTHCARE

ELEMENTS OTHER THAN THE GLOVE MATERIAL THAT DETERMINE

THE LEVEL OF BARRIER PROTECTION INCLUDE:

PROCESS FLOW DIAGRAM

FORMULATION

NR & NBR LATEX

ADVANTAGE & DISADVANTAGE

THE QUALITY-CONTROL PHASE

MARKET SURVEY

PRODUCT SEGMENT

FORM SEGMENT REVIEW

KEY BENEFITS FOR INDIA DISPOSABLE GLOVES MARKET:

BY PRODUCT

BY FORM

BY APPLICATION

BY DISTRIBUTION CHANNEL

LAYOUT OF PHARMACEUTICAL BUILDING & SERVICES

STORAGE CONDITIONS

1. SHELF-LIFE DURATION OF STUDIES

2. EXPIRATION DATES

3. TEMPERATURE

4. ENVIRONMENTAL FACTORS

5. SPECIAL LABELING RESTRICTIONS

PHARMACEUTICAL PLANT LAYOUT

FEATURES OF A GOOD PHARMACEUTICAL PLANT LAYOUT

GOOD CGMP DESIGN FEATURES INCLUDE:

FLEXIBILITY:

MATERIALS OF CONSTRUCTION & SURFACE FINISHES

TYPICAL SEAMLESS EPOXY RESIN FLOORING SYSTEM

MATERIALS OF CONSTRUCTION & SURFACE FINISHES

CEILING SYSTEMS

CLEAN ROOM DOORS

STEEL DOORS

ELECTRIC SLIDING

GLAZING GLAZING

AIR SHOWERS

CLEAN ROOM PRESSURIZATION - EXAMPLE

MACHINERY SUPPLIERS

ETO UNIT

PACKAGING MACHINE

RAW MATERIAL SUPPLIERS

LATEX GLOVES

MACHINERY PHOTOGRAPHS

RAW MATERIAL PHOTOGRAPHS

LATEX GLOVES

EHYLENE OXIDE

APPENDIX – A:

1. COST OF PLANT ECONOMICS

2. LAND & BUILDING

3. PLANT AND MACHINERY

4. FIXED CAPITAL INVESTMENT

5. RAW MATERIAL

6. SALARY AND WAGES

7. UTILITIES AND OVERHEADS

8. TOTAL WORKING CAPITAL

9. COST OF PRODUCTION

10. PROFITABILITY ANALYSIS

11. BREAK EVEN POINT

12. RESOURCES OF FINANCE

13. INTEREST CHART

14. DEPRECIATION CHART

15. CASH FLOW STATEMENT

16. PROJECTED BALANCE SHEET

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