Healthcare Packaging detailed syllabus for Printing & Package Technology (PPT) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the PPT students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Printing & Package Technology 7th Sem scheme and its subjects, do visit PPT 7th Sem 2019 regulation scheme. For Professional Elective-IV scheme and its subjects refer to PPT Professional Elective-IV syllabus scheme. The detailed syllabus of healthcare packaging is as follows.
Course Objective:
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Unit I
Basics of Pharmaceutical Packaging and Process
Types of Pharmaceutical products, Physical forms, Levels of Packaging, approved materials, Packaging Materials for tablets, capsules, syrups, ointments, Dry powders sprays, I.V. fluids, pre-fillable inhalers, pre-fillable syringes, Parental vials, ampoules, product spoilage mechanisms. Pharmaceutical good manufacture requirements, Pharmaceutical machineryfilling and sealing machines for injection, infusion and screw neck bottles, ampoules, prefilled syringes and cartridges, parental stoppers, flip-top closures, unit dose packaging, bulk package, universal product code, global trade number, package inserts, smart labels
Unit II
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Unit III
Package Sterilization Methods
Terminologies and Definitions, Types of Sterilization, Sterilizing Methods/ Agent, Variables that affect sterilization , Pros and Cons of each method with respect to the packaging, MSI / PSI / SAL, Heat Sterilization and Suitable Package Material, Dry, Wet (Steam), Gaseous Sterilization and Suitable Package Material, Ionizing Radiation Sterilization and Suitable Package Material, Gas Plasma Sterilization and Suitable Package Material, Liquid Sterilization and Suitable Package Material, Shelf Life stability study -ASTM F 1980, Aseptic Presentation, Storage Autoclave Case System and Instrument Cassette Designs.
Unit IV
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Unit V
International Standards and Compliance
Overview of medical device Quality System – ISO 13485, US FDA- 21 CFR 820 and EU MDR-745/2017. Healthcare Packaging international standards / ISO 11607 Part 1,2 and EN 868-1, Transport Simulation tests per ASTM D 4169, ASTM D4332. Healthcare Packaging Labeling and Barcode Labelling -21 CFR 801 – Labeling, 21 CFR 830- Unique Device Identifier(UDI) and Packaging Symbols Used in Labeling – ISO 15223
Course Outcome:
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier..
References:
- Medical Device Packaging Handbook, 2nd edition Revised and Expanded; Max Sherman
- Pharmaceutical Packaging Handbook, Edward Bauer
- ISO 13485- Medical Device – Quality Management Systems Requirements for regulatory purposes
- US FDA 21 CFR 820: Medical Devices – Quality system regulations
- ISO 11607- 1 and 2: Packaging for Terminally sterilized Medical Devices
- ISO 15223: Medical Devices – Symbols to be used medical devices labels, Labeling and information to be supplied
- US FDA 21 CFR 801: Healthcare Labeling
- 21 CFR 830: Unique Device Identified
- ASTM D 4169: Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F 1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
For detailed syllabus of all the other subjects of Printing & Package Technology 7th Sem, visit PPT 7th Sem subject syllabuses for 2019 regulation.
For all Printing & Package Technology results, visit Anna University PPT all semester results direct link.