Detailed Project Report on TECHNOLOGY HAND BOOK ON HOSPITAL DISPOSABLE PRODUCTS (MEDICAL, SURGICAL, BLOOD COLLECTION TUBE, LATEX GLOVES, IV CANNULA, GOWNS, FACE MASK, CATHETER, COTTON BANDAGE, SYRINGES AND NEEDLES)

TECHNOLOGY HAND BOOK ON HOSPITAL DISPOSABLE PRODUCTS

(MEDICAL, SURGICAL, BLOOD COLLECTION TUBE, LATEX GLOVES, 

IV CANNULA, GOWNS, FACE MASK, CATHETER, COTTON BANDAGE, 

SYRINGES AND NEEDLES)

INTRODUCTION

Medical Device Manufacturing a primer

Design, Prototyping and Product Development

Design and developing

Prototyping products

Conforming to international Standards

Prototype fields of research

Pilot Medical Device Manufacturing

Cell Manufacturing

Medical Device Component Creation

3D Printing

Welding

Medical Device Software Development

Quality Control

Packaging

Manufacturing medical devices

Importance of Testing

CE MARKING

Meaning of CE

Meaning of CE Marking

How to obtain CE marking?

Medical devices

Regulatory context

Classification and choosing the Conformity Assessment Route

Preparing for the assessment procedure the technical file

Conformity Assessment routes

Final steps to CE mark

Exemptions from CE marking

Active Implantable Medical Deices

In Vitro Diagnostic Medical Devices

Competent Authority

Notified Body

Guide to CE Marking

Reproduce the CE marking

Steps for Class 1 Medical Devices Compliance

Conformity Assessment Procedure

CLEANROOM TECHNOLOGY

Introduction

Humans in Cleanrooms

Contamination Process

Common Cleanroom Contaminants

Best practices for Entrance Rooms, Garment Rooms, Ante rooms

Hand Washing Best Practices for Clean rooms

How to wash hands with Soap & Water in a Cleanroom

Sterile Gloving Technique for Cleanrooms

Cleanroom Gloves

Best Practices for Donning Cleanrooms Gloves

Cleanroom Gowning Procedure and Protocol

Cleanroom Gowning Procedure Checklist

Gowning Order Variations

Sources of contamination

Key Elements of Contamination Control

List of Some of Equipment & Supplies Needed to Clean the Cleanroom 

Cleanroom Aparel

Cleanroom Cleaning Supplies

Cleanroom Equipment

Cleanroom Air Showers

Containment Hoods

DI Water Spray Guns

UV Disinfection Equipment

Dessicator Cabinets

Equipment for cleanrooms and labs

Classification of Clean rooms

According to ISO 146441

According to FS 209

According to the EU GMP

Particle Size Range

ISO 5/Grade A

ISO 6/Grade B

ISO 7/Grade C

ISO 8/Grade D

Conventionally Ventilated Cleanrooms

Unidirectional Airflow Cleanrooms

Mixed Flow Cleanrooms

Isolator or Mini environment

Mini Environments

Mixed ar flow

Federal 209e Stardards

Reticle Mini environment was made as a test station for 200mm microelectronic circuit masks

USP Standards

AsTM International Standards

GMP & CGMP Regulations

Cleanroom Garment System

Cleanroom garment fabrics

Cleanroom garment attributes

The balance between comfort and filtration efficiency

Patient safety versus comfort of the personnel

Cleanroom garments in GMP operations

Quality Risk Management

Quality Risk Management Cleanroom garments

Cleanroom use and clean room garments in the future

Testing cleanroom garments

Cleanliness of fabric and (or) garment

Effect of the Garment Design on Dispersion

Comparison of Clothing made from Different Fabrics

Disposable Cleanroom Suit Fabric Types

Spun bonded or Thermal Bond Fabric

Clash Spun Fabric

Melt Blown Fabric

Spun bonded/Melt Blown/Spun bonded (SMS) Fabric

Film Laminates Fabric

Microporous Film Laminate Fabric

General Cleanroom Regulations

Layout of Cleanroom Suite

Cleaning Methods and the Physics of Cleaning Surfaces

Cleaning Methods with Respect to Area type

Step-1 Understanding cleaning and disinfection

Step-2 Selecting the most appropriate agents

Cleaning Method of Cleaning Surfaces

Step-3 Understanding types of disinfectants

Step 4: Validating disinfectants

Step 5: Factors which affect disinfectant efficacy

Step 6: Cleaning materials

Step 7 Cleaning techniques

Step 8: Monitoring cleaning and disinfection efficiency

Cleaning Methods with Respect to Area Type

Choice of Materials

Flooring options

Locating viewing panels

Choose easy to clean doors

Test Methods

ISO Class 1

ISO Class 2

ISO Class 3

ISO Class 4

ISO Class 5

ISO Class 6

ISO Class 7

ISO Class 8

Furniture

Cleanroom Chairs

Cleanroom Tables

Gowning Benches & Racks

General Cleanroom Furniture Considerations

Specifications

Hygiene

Resilience

Final Thoughts

General Cleanroom Regulations

Personal Actions Typically Prohibited in Cleanrooms

MEDICAL DEVICE PACKAGING

Packaging

Packaging Design Controls

User Preference

Understanding User Requirements

Packaging Material

Paper

Tyvek

Aluminium

Plastic

Adhesives & coatings

Inks

Package Validation

Validation Testing

Where to Look When a Failure Occurs

Integrity Validation Fallures

Dye Migration Test tests packaging seals for weakness

Strength Validation Failures

Microbial Validation Failures

Procurement, Acceptance and Storage

Analyze prices

Purchase timing

Assess suppliers

Sourcing process

Packaging Process

Package design considerations

Sterilization options

Package testing requirements

Validation processes

Product Specification Pouch

Header Bag (Specification Form)

Header Bag

Mandatory Label Information

Label integrity

Receipt and inspection

Area Separation and Inspection

Storage

Label Check and Record

Changes

Relabeling and Overlabelling

Control Number

Product Identity Declartion

Not quantity deciaration

Dealer name and place of business (dealer identification)

Language

Location

Type face

Type height

Imported goods

Bulk imports

Country of origin marking

Net Quantity Declaration

Manner of declaring

Location and manner of presentation

Type face

Type height

Minimum type heights

Units

Units of measurement

Choice of units

Precision of number

Exemptions

Dealer's name and principal place of business

Definition

Language

Location

Type face

Type height

Imported goods

Other

General exemptions

Bilingual labelling

Exemption from the detailed the detailed labelling requirements

Different Stages of Packaging

Primary Packaging

Secondary Packaging

Tertiary Packaging

Chevron pouches for medical devices

Corner peel pouch

Tear pouches

Header bags

Chevron header pouches

Lidded thermoformed trays

Lidded rigid trays

Lidded flexible trays

Die Cut Backer Cards

Recycling

Benefits of Using a Backer Card

Folding Cartons

Corrugated Shipping Containers

Packaging Standards

Packaging for Terminally Sterilized Medical Devices

ASTM International Standards Fall into Six Categories

ASTM D Standards

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye

Penetration

Current Good Manufacturing guidelines for Finished Pharmaceutical Goods

Guidelines

Materials examination and usage criteria

Labeling issuance

Packaging and labeling operations

Drug product inspetion

Expiration dating

DISPOSABLE BLOOD BAGS

Introduction

Flexible PVC Blood Bags

Properties of Disposable Blood Bags

Raw Material

Plant & Machinery

Quality of the Raw Materials

Translucency so can check if full, and see layers in centrifuged bags

Neural surface

No damage when bent to a small radius

Heat resistance, so can steam sterilise prior to use

Must not burst in the centrifuge, or tear on handling

Permeable to oxygen, but not too permeable to water

Moderate cost

Processing and welding

Assessment

Manufacturing Proess

Raw Material Required

Blood Bag Manufacturing Flow Chart

Blood making/Forming machine

DISPOSABLE PLASTIC GLOVES

Latex Gloves

Nitrile Gloves

Vinyl Gloves

Ansell gloves for cleanroom

Types of disposable gloves

Properties

Glove Selection

Raw Materials

Uses of Disposable Gloves

Medical Usage

Food Service Usage

Industrial Usage

Home Use

Machine and Equipment Required

Manufacturing Process

Further Process

Latex disposable gloves Production Unit Setup & Machinery

Production Process & Technology

Glove Manufacturing Machines

Flow chart of production line

Flow chart of production

Addresses of Machinery & Equipments Suppliers

Computer Control Glove Making Machine

Non Woven Glove Sewing Machine

Addresses of Raw Material Suppliers

DISPOSABLE MASKS

Introduction

The formal production process of medical masks

Be secured with ties or ear loops

Uses & Applications

Cover the nose and below the chin

Fit snuggly but comfortably against the side of the face

Include multiple layers of fabric

Allow for breathing without restriction

N95 respirators

Properties

Surgical mask

Manufacturing Process of Disposable Surgical Masks

The formal production process of medical masks

Combine three layers of non woven fabric

Stich the metal wire fixed by the nose clip into the laminated three layer non woven fabric

Folding mask

Disinfection

Equipment required for medical masks

Sterilization

Biocontainment

Sterilizing Masks with Vapor

Microwave Generated Steam (MGS)

MGS Disinfection Setup

Warm Moist Heat (WMH)

UVGI

WMH Disinfection Setup

General Implementation

Mask Making Machines

Flow Diagram for Disposable Surgical Mask

Fully automatic N 95 Face Mask Making Machine

Surgical Mask Sewing Machine

Mask Blank Machine

Addresses of Machinery & Equipment Suppliers

Address of Raw Material Suppliers

DISPOSABLE SURGICAL  CATHETERS

Introduction

Properties and materials

Uses

Common Features of Central Venous Catheter

Manufacturing Process of Catheters

A Foley catheter

Raw Materials

Design

Quality Control

Byproducts/Waste

Example of indwelling catheters

Process Flow Diagram of Catheter

Process flow of manufacturing catheters

Catheter Production Equipments

Hole Punching, Drilling and Cutting Services

Catheter Lamination

Identification & Surface Atribute Services

Catheter tip forming methods

Plant & Machinery Supplie

Suppliers of Raw Materials

DISPOSABLE SURGICAL WEAR (SURGICAL GOWNS, BED SHEETS, PILLOW COVER, CAPS)

Introduction

Bed sheet

Pillow cover

General Construction for Disposable Gowns

Front and back of a surgical gown

Sizing Analysis of Disposable Gowns

Standards for Gowns

U.S. Standard of Gowns

EU Standard of Gowns

Products: Description

Raw Material of Medical Supplies

Classification of Non-Woven Fabrics according to the Production Process

Heat Sealing Non Woven

Pulp Airlaid Non woven

Wet Non woven Fabric

Spunbond Non woven

Meltblown Non woven

Needle Punched Nonwoven

Stitching Non woven

Hydrophilic Non woven

CPE Shoe Covers

Face Masks

Non Woven Face Mask

Advantages

Disadvantages

Dust Mask

Description of Surgeon Gowns

Description of Patient Gown

Description of Surgeon Suits

Raw Materials

Protective Materials

Spun Bond Polypropylene

Steps in spun bonding process

SMMS

DuPont T Isolation Wear T Medical Fabrics

Coated Polypropylene

Breathable Laminate

Characteristics

Laminate for dental drapes

Manufacturing Process

Manufacturing Process Flow Chart

Machinery images & Details

Surgical Gown Sewing Machine

Machine Functions

Machine Characteristics

Machine Advantage

Machine Parts Name

Non Woven Gown making Mahine

Disposable Surgical cap making machine

Surgical Disposable Products Photograph

Surgical Gowns Disposable Apron

Disposable Gown 

Disposable Surgeon Gown

Disposable Bouffant Cap

Disposable Coverall

Disposable Surgical Cap

Disposable Mob Cap

Disposable Surgical Bed Sheets

Plant & Machinery Suppliers

DISPOSABLE PLASTIC SYRINGES

Introduction

Uses

Necessity of Disposable Syringes

Parts of a Disposable Syringe

Disposable syringe and needle (parts labelled)

Raw material used for manufacturing disposable syringes

Sterility

Packing

Primary packaging

Labelling on the primary packaging

Secondary packaging

Process of Manufacture

Quality Control

Machinery Images

Full Automatic Disposable Medical Plastic Syringe Plunger Barrel and Needle Making Injection

Molding Machine

Syringe Plunger Moulds

Disposable SyringePackaging Machine

Storage of Sterilized Articles

Test for Detection of Aerobic and Anaerobic Organism Media

Medium for Anaerobic Organism

Nonselective Media used in anaerobic bacteriology

Selective and differential media used in anaerobic bacteriology

Addresses of machinery and Equipment Suppliers

Addresses of Raw MaterialSuppliers

INTRA VENOUS (I.V.) CANNULA

Introduction

Types of IV Cannulas and Their Uses

Uses and Application

Nasal cannula

Application of Cannula

Veterinary Usage of the  Cannula

Aesthetic medicine and anti ageing

Body piercing

Non medical use

Nasal Canula(Oral nasal cannula)

Butterfly Needle

Application of Butterfly Needle

Butterfly Needle and cannula

Venipuncture

IV hydration

Medication

Raw Material

Polymers Used in Plastic Moulding

Nylon Applications, Grades, and Brands

Polycarbonate (PC)

Polyethyelene (PE)

Polyamides and PA Properties

Polyethylene Properties

LDPE Properties

Polypropylene

Properties of Polypropylene

Polyvinyl Chloride (PVC) Properties

Properties of PVC

Medical Grade Plastic

Manufacturing Process of IV Cannula

I.V Cannula manufacturer & about the product

IV Cannula process

Theory of the in Line screw type injection molding machine

Manufacturing Process of IV Cannula

Plastic Moulding

Plastic Moulding Techniques

The Plastic Molding Processes

Injection Molding

Blow Molding

Compression Molding

Film Insert Molding

Gas Assist Molding

Rotational Molding

Preparing the Mould

Heating and  Fusion

Cooling the Mould

Unloading/Demoulding

Structural Foam Molding

Thermoforming

Plastic Injection Moulding

Preparing the Mould

Injection of Polymer Melt into the Mould

Cooling the Mould

Unloading/Demoulding

The Blow Moulding Process

Injection Blow Moulding

Extrusion Blow Moulding

Stretch Blow Moulding

The Compression Moulding Process

Plastic Extrusions

Manufacturing Process Assembly Line

Needle

Needle Hub

Needle Cover

Catheter

Wings (DS101 & DS105)

Injection Port (DS101 only)

Catheter Material as per USP standards Class VI

USP Class VI and Biocompatible Rubber

Process Description of the Assembly Line

Importance of Assemble Line

Semi Automatic Body Assembly/Wing Assembly Machine

Product Description

Semi Automatic Tip Forming Machine

Automatic Silicon Tube Cutting Machine

Automatic Luer Lock & Fish Back Chamber Assembly Machine

Automatic Needle Assembly Machine

Automatic Catheter Cutting Machine

Automatic Bilister Packing Machine

Cannula Assembly Machine

Body Assembly Machine

INFUSION SET AND BLOOD TRANSFUSION SET

Introduction

Features of Blood Transfusion Set

Before the procedure

During the procedure

After the procedure

Blood Transfusion Process Protocol

Blood Transfusion Steps

Initiating the Blood Transfusion

During the Transfusion

After the Transfusion

Blood Transfusion Recovery

Product Description

Blood Administration Set

Disposable Infusion Set

Disposable Blood Giving Set

Disposable Blood Giving Set

Micro Flo Air Micro Drip Set

Micro Flo Eco Micro Drip Set

Micro Flo Air MicroDrip Set

Blood Transfusion Set Sus (Double Chamber)

Blood Transfusion Set Haemodrip (Double Chamber)

Blood Transfusion Set Haemodrip (Double Chamber)

Blood Transfusion Set Easy (Single Chamber)

Blood Donor Set

Blood Transfusion Set Easy (Single Chamber)

Infusion & Transfusion

Scalp Veln Set

Scalp Veln Set

Blood Donor Set

Measured Volume Set (Paedia Drip)

I.V. Cannula (With wing & wing injection port)

Measured Volume Set (Paedia Drip)

A.V. Fistula Needle

Peritoneal Dialysis Transfusion Set

A.V. fistula needle 

Manufacturing Process

Plastic Injection Moulding

Preparing the Mold

Injection of Polymer Melt into the Mould

Cooling the Mould

Unloading/Demoulding

Blow Moulding

Common Uses for Blow Moulding

Injection Moulding

Common Uses for Injection Moulding

Extrusion Blow Moulding

Steps of EBM process

Stretch Blow Moulding

The Compression Moulding Process

Compression Moulding Basics

Advantages of Compression Moulding

Plastic Extrusions

Assembly Processes

Process Flow Diagram

Description of Machinery

Tubing Cutter

Pneumatic Angled Tube Cutter

Tubing Cutter-Pneumatic Operated

Molded Tubing Cutting Machine

Vibratory Bowl Feeders or Hose Assembly Machine

Engineers India Research Institute (EIRI) is a renowned name in the industrial world for offering technical and financial consultancy services.

EIRI services are:

Detailed Feasibility Reports

New Project Identification

Project Feasibility and Market Study

Identification of Lucrative Industrial Project Opportunities

Preparation of Project Profiles / Pre-Investment and Detailed Feasibility Studies,

Market Surveys / Studies, Market Survey Cum Detailed Techno-Economic Feasibility Reports

Project Reports in CD Roms

Identification of Plant /Process/Machinery and Equipment, Industrial General Guidance for setting up new industrial projects.

Our most up-to-date and Technologically Advanced Industrial Project Reports, categorized with respect to Financial Outlays and Sector – wise Classification are immensely useful for :

Existing Small or Medium Scale Industrialists facing competition from large houses

Young Entrepreneurs dreaming to start their own industrial enterprise

Young Graduates and Professionals wishing to begin their career

Industrialists interested in Debottlenecking  their capacities & New Product – Lines

Large Industrial Houses pursuing  Expansion, Growth and Diversification Plans