WORLD-WIDE MARKET

• US$ 200 Billion = Rs. 900,000 Crores

• Annual Growth rate = 10 %

• No. of Industries = > 65,000

• Market share of first 40 indus. = 60 %

• U.S.A. Annual Consumption = > 40 % 

PACKAGING

The third largest sales volume business in the world

BASIC PACKAGING

• (45 Years Earlier) Metal 

• Composite Cans

• Tubes 

• Glass Containers

• Boxes

• Cartons

• Bags 

Plastics were seldom used

MEDICAL DEVICE PACKAGING CONSIDERATIONS

• End use

• Temperature

• Moisture Resistance

• Sterilization process

• Thermal capacity

• Disposability : Single Use
                       Multiple Use

• Device Composition

• Device Size & Shape

• Adhesive

• Cling Resistance

• Pressure

• Vacuum

MEDICAL DEVICE PACKAGING REGULATORY ASPECTS

• Protection FRom

  • Environment

  • Microorganism till opened

  • Adulteration

• Protection During 

  • Handling & Shipping

• Storage up to  Shelf Life

• Labeling

• Easy to open

• Safe User Friendly 

• Quality Assurance

  • Testing Raw Material

  • Sterility after Sterilization

Avoid mix up Sterile-Nonsterile

INTERNATIONAL STANDARDS

• ISO 11607/EN 868-1
  Packaging for Terminally Sterilized Medical Devices

• ISO 13485 
  Quality Management System : Special requirement for Medical Devices. 

USER UNDERSTANDING

• Limited to 

  • Sterility

  • Shelf Life :One-Two Year Old

  • Single / Multiple 

    • No. of Devices

    • No. of Uses 

NURSES PREFERENCES

• Infection Control (96%)

• Quality Package : Select (90 %)

• One side Transparent (87%)

• Whiteness on Opened Seal (95%)

• Sterlization Indicator (89%)

• Fiber-Free Opening (99%)

• High-Profile Device in Tray (55%)

• Black Printing for Easy Read (55%)

DOCTOR PREFERENCES

• Clean, Fibre-Free Opening

• Double Packaging

• Use Instructions

• Easy-Open Notch on Chevron

• Lids with Adhesive Transfer

MANUFACTURER

• Satisfies Customer Requirement

• Satisfies Regulatory Requirements

• Looks for Cheap Option

• Less Volume

• What Competitor is Using

REGULATORY AGENCY

• Sterile vs. Non-sterile

• Any Complaint

• GMP

• Not Covered Under Drugs & Cosmetic Act & Rules : No Control

• Limited Lab Facility

PACKAGING RELATED RECALLS (10 % OF ALL RECALLS)

MEDICAL DEVICE PACKAGING PRIMARY 

• Trays or Blisters (Thermoformed)
  

• Pouches : Flexible, Pillow
  

• Pre-Fillable : Uninfected
  

• Plastic Bottle
  

• Shrink Wrap Film
  

• Stretch Film