Description
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
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