Effect on moisture permeability of typewriting on unit dose package surfaces

Area of Science:

• Pharmaceutical Packaging
• Drug Delivery Systems
• Material Science

Background:

• Unit dose packaging is critical for maintaining drug stability and efficacy.
• Accurate labeling is essential for safe medication administration.
• The impact of direct labeling methods on package integrity is not well-documented.

Purpose of the Study:

• To investigate the effects of typewriting on the moisture permeability of two types of unit dose packages.
• To determine if direct typing compromises the United States Pharmacopeia (USP) Class A rating.
• To assess the suitability of typed unit dose packages for pharmaceutical use.

Main Methods:

• Two types of USP Class A unit dose packages were subjected to direct typewriting using an electric typewriter at varying impact settings.
• The official USP test for water permeation was conducted on both typed and untyped control packages.
• Package integrity and moisture permeability were evaluated based on USP standards.

Main Results:

• Increased typewriter impact settings correlated with a significant rise in moisture permeability for both package types.
• Typed packages showed a reduction in USP rating from Class A to Class B and D.
• Some packages subjected to higher impact typing became unsuitable for use under current FDA repackaging standards.

Conclusions:

• Directly typing on unit dose package labels before sealing can damage the packaging and render it unfit for use.
• Pharmacists should utilize the lowest possible typewriter impact settings when labeling unit dose packages.
• Implementing the USP moisture-permeation test is recommended to verify package integrity after labeling.