paharmaceutical packaging Medical device Packaging types of medical device packaging primary and secondary packaging

Medical device packaging science

1. Pharmaceutical packaging Presenter Ravichandra Nadagouda NH0120008 Pharmaceutical Quality Assurance 1

2. CONTENTS INTRODUCTION Types of packaging Different types of packaging material Medical device packing Reference 2

3. What is packaging ? Packaging can be defined as an art, science and technology to ensure the safer delivery of the product throughout its journey from marketing to that end use. 3

4. Functions of packaging 4

5. Ideal qualities of a pharmaceutical packaging It should have sufficient mechanical strength so as to withstand handling filling closing and transportation It should not react with the contents stored in it It should of such shape that can be elegant also the contents can be easily drawn from it It should not leach alkali in the contents The container should not support mold growth The container must withstand the heat when it is to be sterilized 5

6. Ideal qualities of a pharmaceutical packaging The contents of the container should not be absorbed by the container The material used for making the container should be neutral or inert Any part of the container or closure should not react with each other Closure should of non toxic nature and chemically stable with container contents 6

7. Types of packaging Primary packaging Secondary packaging Tertiary packaging 7

8. Primary packaging Primary packaging are those package which are in direct contact with the pharmaceutical formulation The main aim of primary package is to protect the formulation from environmental, chemical mechanical and other hazards. 8

9. Secondary packaging The package external to primary package is known as secondary packaging This package provide additional protection during warehousing and also provide information about drug product for e.g. leaflets. 9

10. Tertiary packaging It is outer package of secondary packaging and prevents damage to the products It is used for bulk handling and shipping 10

11. Types of packaging material 11

12. Medical device packaging What is a Medical Device? An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: Recognized in the Formulary, or the Pharmacopoeia, Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or Intended to affect the structure or any function of the body of man or other animals 12

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14. Medical device packing Selection of packaging style can impact package integrity. The type of package is largely driven by the characteristics of the device being packaged. These include size, shape, profile, irregularities, density, weight, and configuration. Parameters for selection of packaging material : Critical product characteristics Type of protection required(physical , UV , light, Oxygen water vapor transmission, etc.) Type of sterilization process Where and how the product is going to be dispensed( OTC, surgery , etc.) 14

15. Early packaging forms for medical devices included bags, cartons, and wraps; the primary material was paper. Glass and metal containers were used to lesser extent. The coming of Thermoformable materials in 1950s and 1960s made tray and blister packaging possible, but the lack of good lidding materials limited their expansion. Boxes , cartons , and paper bags were not easy to use , inconvenient to dispense and difficult to provide sterile delivery . The introduction of new thermoplastic polymers and peelable materials, along with improved film lamination has led to the packaging forms most commonly used today 15

16. Package types used in medical device packing Thermoform trays Flexible formed pouches Flexible non-formed pouches 16

17. Thermoform Trays (Semirigid) Thermoformed trays are commonly used for surgical procedure kits and are ideal for high-profile, irregularly shaped devices. There are two types of thermoformed trays: semirigid and flexible. The most important difference is that semirigid trays are structurally self supporting. They can provide good physical protection and are suitable for multicomponent applications. Formed flexible packaging is more suitable for low-cost devices and for simple tray configurations, but do not offer the same degree of structural protection as the semirigid trays. 17

18. Thermoform trays 18

19. Advantages of thermoform trays Ease of forming Heat resistance Sterilization compatibility Sealant compatibility Cost-effective 19

20. Flexible Non formed Pouches This type of pouch is commonly used for single-use disposable items such as gloves, catheters, tubing, adhesive bandages, dressings, syringes, and so on. Flexible packages tend to provide less physical protection than the rigid ones (10) and are a preferred choice for high-volume, low-cost devices. It is a packaging form that provides: a sterile barrier, the ability to withstand sterilization, and, if properly designed, easy opening features for dispensing. 20

21. Flexible non formed pouches 21

22. Characteristic Relatively low cost, suitable to high-volume, low-cost devices May be made to be heat sealable Ease of forming Available for form-fill-seal operations Suited to relatively simple tray configurations Can conform to product Good visibility of product Cannot be preformed Offer little structural protection Limited variety of materials available Relatively lower heat resistance 22

23. Flexible Formed Pouches Flexible material is drawn by the thermoform process into a flexible “tray.” Packages are generally not self-supporting 23

24. Characteristics Relatively low cost, suitable to high-volume, low-cost devices May be made to be heat sealable Ease of forming Available for form-fill-seal operations Suited to relatively simple tray configurations Can conform to product Good visibility of product Cannot be preformed Offer little structural protection Limited variety of materials available Relatively lower heat resistance 24

25. Primary materials 1. Tyvek Tyvek is a spun-bonded olefin, is used in almost every major form of sterile package composed entirely of extremely fine, continuous strands of high-density polyethylene. Tyvek is used most often with ethylene oxide (ETO) sterilization Other attributes • Water repellency. • Chemical resistance. • Radiation stability. • temperature stability. 25

26. 2. Films and Laminates Many films are used in medical device packaging applications. Both flexible formed and non-formed pouches, as well as bags . Available in mono films, and laminations. 26

27. 3.Paper For many years, paper was the only choice for package types until the introduction of Tyvek However, paper still plays a significant role in the medical device industry. 27

28. 4. Foils Foil laminate materials are used in applications where high moisture, gas, and light barriers are essential. It is used for Lidding of thermoform tray packages Wet devices such as dressings, solutions, sponges, swabs For solutions Foil laminations with high-density polyethylene or polypropylene are common constructions for these package types . 28

29. . 5 . Thermoformable Plastics The most widely used package materials Provides aesthetic appeal, medical device applications, and versatility for customized designs to fit Polyethylene Terephthalate (PET) is probably the most widely used material for medical packaging applications Polycarbonate (PC). Polycarbonate is used for high-performance package applications where high strength and toughness are required. Polyvinyl Chloride (PVC) and Polyvinylidene Chloride (PVDC). Polystyrene (PS) is one of the most versatile, easily fabricated, and cost effective plastic used in the packaging industry 29

30. Secondary Materials Paperboard Cartons Corrugated Fiberboard Boxes 30

31. Refence Medical device packaging by Laura bix Textbook theory and practice of industrial pharmacy 31

32. THANKYOU 32