Pharmaceutical Packaging: Moisture Permeation
Package integrity is necessary to maintain a drug product’s quality throughout its shelf life. Thus, packaging systems must demonstrate satisfactory container-closure integrity. Package moisture permeation is a critical quality attribute for solid oral dosage forms, with moisture uptake being a common cause for product package failures. Current permeation methods in USP Chapter Container—Performance Testing <671> establish equivalence for packaging (cap/bottle and blister packs) based on the USP standards of well-closed or tight containers. The chapter is being revised to include a new permeation method for pharmaceutical manufacturers.
This workshop will provide a platform for stakeholders to discuss proposed revisions to USP’s permeation and leak standards and to future chapters.
- USP activities regarding the revision to current Containers—Performance Testing <671>
- New permeation tests for pharmaceutical manufacturers
- Current permeation test classification (well-closed or tight container) and future classification expansion
- Moisture permeation testing for high barrier vs. low barrier materials
- Desiccant choice and amount
This workshop is intended for all stakeholders (industry, regulators, and associations) interested in furthering the science of maintaining packaging integrity for solid oral forms. This includes professionals working in or with:
- Research and Development
- Contract Research Organizations
- Contract Manufacturing Organization
- Contract Packagers and Repackagers
- Packaging Component Manufacturing
- Packaging Component Suppliers
- Regulatory Affairs
- Quality Assurance/Quality Control
- Association/Government/Academic (AAG)—$395
- Association/Government/Academic (AAG)—$295
Three or more attendees from one organization (no deadline):
- Association/Government/Academic (AAG)—$195
- Student (must present valid student ID)—$100
Registration fees are listed per person and include one-day program, meeting materials, continental breakfast and lunch.