Saturday 11 June 2011

Syllabus Pharmaceutical Packaging Technology

Syllabus- Pharmaceutical Packaging Technology
Chapter Title
Page No
Chapter-1 Pharmaceutical Packaging Technology
1.1 Introduction
1.2 Packaging
1.3 Classification of Packaging
1.4 Packaging Essential Requirements
1.5 Functions of Packaging
1.6 Importance / significance of Pharma Packaging
1.7 The main packaging materials
1.8 The Ideal Package
1.9 Properties of Ideal Packaging Materials
1.1  1.10 Packaging formats in Pharma Industry
1. 1 1.11 Packaging recycling symbols
       1.12 FDA Definitions
 .     1.13 New Concept and Future of Packaging

Chapter-2 Package Design Research and New Trends In The Pharmaceutical Packaging
2.1 Introduction
2.2 Pharmaceutical Container
2.3 Approach to package design
2.4 New Trends in the pharmaceutical packaging

Chapter-3 Packaging Materials
3.1 Introduction
3.2 Packaging materials
3.3 Classification of Packaging materials

Chapter-4 Polymers And Plastics
4.1 Introduction
4.2 Plastics
4.3 The Structure of Polymers
4.4 Raw Materials of Plastics
4.5 Types of Plastics
4.6 Resin identification code
4.7 Availability of recycling facilities
4.8 Plastics and Packaging

Chapter-5 Glass
5.1 Introduction
5.2 Selection of glass as packaging materials for the pharmaceutical products
5.3 Properties of glass
5.4 Production of glass
5.5 Types of glass
5.6 Other types of glass
5.7 Factors other than USP Type
5.8 Manufacturing of Glass containers
5.9 Features of Glass containers:-
5.10 Test for glass containers
5.11 Advantages and disadvantages of glass containers
5.12 Uses of Glass containers

Chapter-6 Metals in  Packaging
6.1 Introduction
6.2

Aluminium                                                                                                                                       6.3 Aluminium foil                                                                                                                              6.4 Collapsible Tubes                                                                                                                            6.5 Tin                                                                                                                                                       6.6 Lead                                                                                                                                                    6.7 Stainless steel


Chapter-7 Blister And Strip Packaging
7.1 Introduction
7.2 Blister Package
7.3 Blister design parameters:
7.4 Materials
7.5 Formation
7.6 Types of Blisters
7.7 Advantages and disadvantages of Blister Packaging.
7.8 Types of Problems/ Defects
7.9 Blister Packing Machine
7.10 Other packages
7.11 Strip Packs- High Barrier Laminates
7.12 Strip Packaging Process
7.13 Packaging Materials
7.14 Properties of Materials
7.15 Child-resistant strip package
7.16 Strip Sealing Machine
7.17 Strip Packing Machinery
7.18 Multi-Dose Strip Packaging

Chapter-8 Ancillary Materials used in  Packaging                                                                   8.1 Introduction                                                                                                                                   8.2 Adhesives                                                                                                                                   8.3 Paper                                                                                                                                      8.4 Paperboard                                                                                                                                   8.5 Leaflets                                                                                                                                        8.6 Package Insert                                                                                                                             8.7 Package outserts                                                                                                                              8.8 Fiberboard                                                                                                                                          8.9 Jute                                                                                                                                              8.10 Wood


Chapter-9 Natural And Synthetic Rubber                                
9.1 Introduction

Chapter-10 Closures And Liners
10.1 Introduction
10.2 Types of closures
10.3 Classification of contemporary closures by their utility
10.4 Special-purpose Closure
10.5 Closure Functions
10.6 Closure Materials
10.7 Types of Plastic Closures
10.8 Sealing Systems
10.9 Liners
10.10 Closure Liner Functions
10.11 Classification of Liners
10.12 Selection of Lining Material
10.13 Options for Closure Liners
10.14 Innerseals
10.15 Linerless Closures
10.16 Types of tapes
10.17 Strapping Materials
10.18 Evaluating Closure Liners
10.19 Standard Liners
10.20 Tacseal  
10.21 Solutions
10.23 Liner Description
10.22 Liner Designations


Chapter-11 Corrugated Fibre Board Materials                                                                            11.1 Introduction                                                                                                                             11.2 Components of C.F.B.
11.3  Types of Corrugated Board
11.4 Advantages & Disadvantages
11.5   Manufacturing
11.6 Box Structure
11.7 Box Dimensions
11.8 Types of Box
11.9 Applications of C.F.B.
11.10 New developments in CFB                                                                                                    11.11 Failures in the CFB during Export

Chapter-12 Sterilization of packaging materials
12.1 Introduction
12.2 Pharmaceutical Importance of Sterilization
12.3 Physical and Chemical Factors that affect sterilization
12.4 Terms commonly used
12.5 Classification of Sterilization Methods
12.6 Sterilization of Packaging Materials
12.7 Tests for Sterility
12.8 Incubation and examination of sterility tests
12.9 Interpretation of the test results
12.10 Evaluation of Sterilization Method
12.11 Process of Microbial Destruction
12.12 Evaluation and In Process Monitoring of Sterilization Procedures

Chapter-13 Packaging of Parenterals, Ophthalmics, And Aerosols
13.1 Introduction
13.2 Packaging of Sterile Pharmaceuticals
13.3 Packaging Components
13.4 Inspection of Filled Injectable Products
13.5 Storage and Labelling
13.6 Units of concentration
13.7 Parenteral Packaging Concerns for Drugs
13.8 Packaging of Ophthalmics                                                                                                13.9 Selection of Packaging Materials                                                                                   13.10 Packaging of Aerosols

Chapter-14 Defects In Packages
14.1 Introduction
14.2 Defects in Packaging Material

Chapter-15 Labeling of Packages
15.1 Introduction
15.2 Functions of Labels
15.3 Types of Labels
15.4 Common Applications
15.5 Label Substrate/Materials
15.6 Barcodes
15.7 Printing Processes
15.8 Security Devices
15.9 Promotional Opportunities
15.10 Future Developments
15.11 Legal Requirements of Labels
15.12 XML based SPL - FDA drug labeling standard for pharmas makes for safer medication
15.13 GMPs and Pharmaceutical Labeling
15.14 Printing

Chapter-16 Package Testing And Testing of Containers & Closures                                16.1 Introduction                                                                                                                       16.2 Testing of containers and closures


Chapter-17 Stability of Packages                                                                                                17.1 Introduction                                                                                                                                  17.2 Legislation                                                                                                                               17.3 Regulation                                                                                                                                 17.4 Pharmaceutical Stability Testing in Climatic Cabinets                                                          17.5 Pharmaceutical Stability Testing Conditions                                                                           17.6 BINDER Climatic Chambers                                                                                                      17.7 Photo-Stability Testing                                                                                                            17.8 Review of Pharmaceutical Product Stability, Packaging and the ICH Guidelines


Chapter-18 Packaging Regulations And Legal Requirements                                                   18.1 Introduction                                                                                                                                 18.2 The Regulations - In brief                                                                                                            18.3 Regulation in packaging                                                                                                              18.4 Requirements                                                                                                                               18.5 Packaging (Essential Requirements) Regulations                                                                   18.6 Compliance                                                                                                                               18.7 Enforcement                                                                                                                                  18.8 Offences and Penalties                                                                                                             18.9 Environmental Helpline

Chapter-19 The Package Line and Packaging Functions
19.1 Introduction
19.2 Packaging functions
19.3 Package Line




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