Abstract

The primary objective of this study was to directly compare two distinctly diverse package moisture permeation test methods. The two methods that were compared were the USP <671> Containers Permeation: Single Unit Container and Unit Dose Containers for Capsules and Tablets and the MOCON Modulated Infrared Sensor Method (ASTM F 1249). The tests generate a value known as an MVTR (Moisture Vapor Transmission Rate) value. The focus of this study was to determine whether there is a significant statistical difference between results of the two methods, specifically for unit dose blister packaging. Since MVTR is a package integrity characteristic, it is particularly important to the pharmaceutical industry because of the FDA regulations that govern packaging materials and components. After four different pharmaceutical grade packaging materials were evaluated and analyzed, the statistical results show that there is a significant difference between the two test methods. However it was discovered that due to lack of sensitivity of testing equipment, the statistical data analysis might be suspect.

Library of Congress Subject Headings

Packaging--Materials--Permeability--Testing--Statistical methods; Packaging--Materials--Permeability--Research; Moisture; Tablets (Medicine)--Packaging--Moisture--Testing; Blister packs

Publication Date

2000

Document Type

Thesis

Department, Program, or Center

Manufacturing and Mechanical Engineering Technology (CAST)

Advisor

Plezia, Mark

Advisor/Committee Member

Shorts, R. Scott

Comments

Note: imported from RIT’s Digital Media Library running on DSpace to RIT Scholar Works. Physical copy available through RIT's The Wallace Library at: TS195.8 .M34 2000

Campus

RIT – Main Campus

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