pharma packaging – Page 3

Extractables and Leachables Testing for Combination Products

Comprehensive Guide to Conducting Extractables and Leachables Studies for Combination Products In the pharmaceutical industry, the safety of combination products is paramount. Extractables and leachables testing is critical for ensuring…

How to Prepare an E&L Summary for CTD Module 3

Strategies for Developing an Effective E&L Summary for CTD Module 3 In the realm of pharmaceutical manufacturing, establishing a comprehensive extractables and leachables (E&L) summary is crucial when preparing the…

E&L Failures That Delay Regulatory Approval: Case-Based Lessons

Case Studies: Issues with Extractables and Leachables That Hinder Regulatory Approval In the pharmaceutical industry, extractables and leachables (E&L) studies play a critical role in ensuring that packaging materials do…

How to Manage E&L Risks During Supplier Qualification

Effective Management of Extractables and Leachables Risks During Supplier Qualification In pharmaceutical manufacturing, ensuring that packaging materials do not adversely affect product integrity is paramount. The risks associated with extractables…

Leachables in Semi-Solid Packaging: Tubes, Liners, and Pumps

Identifying and Addressing Leachables in Semi-Solid Packaging In the realm of pharmaceutical manufacturing, the integrity of product packaging can have a significant impact on drug quality and safety. The issue…

Extractables from Rubber Stoppers: What to Test and How to Justify

Addressing Extractables from Rubber Stoppers: Testing and Justification Strategies In pharmaceutical manufacturing, ensuring the integrity and safety of the product is paramount. One critical area often overlooked is the potential…

Lifecycle Management of Child-Resistant and Senior-Friendly Packs

Effective Management of Child-Resistant and Senior-Friendly Packaging Failures Packaging failures in child-resistant and senior-friendly systems can have significant implications in pharmaceutical manufacturing. When these specialized packs do not perform as…

How to Assess Preservative Loss Due to Packaging Sorption

Evaluating Preservative Degradation Due to Packaging Sorption In the pharmaceutical industry, effective preservation of products is crucial to maintain quality and ensure patient safety. However, preservative loss due to packaging…

Designing Packaging That Protects Children Without Blocking Patients

Implementing Child-Resistant and Senior-Friendly Packaging Solutions Effectively When designing pharmaceutical packaging, the dual challenge of ensuring child safety while maintaining accessibility for seniors is paramount. As regulatory bodies increasingly emphasize…

E&L Strategy for Plastic Bottles Used in Oral Liquid Products

Mitigating Extractables and Leachables Risks in Plastic Packaging for Oral Liquid Pharmaceuticals In the pharmaceutical manufacturing realm, ensuring the integrity of products housed within plastic packaging is a critical focus.…

How to Trend Packaging Complaints Related to Usability

Trending Usability Complaints in Child-Resistant and Senior-Friendly Packaging In the pharmaceutical industry, the usability of packaging, particularly for child-resistant and senior-friendly products, is crucial for compliance and patient safety. Packaging…

Extractables and Leachables for BFS Containers: Risk-Based Approach

Case Study on Managing Extractables and Leachables in BFS Containers In the world of pharmaceutical manufacturing, the integrity of packaging systems is crucial for maintaining product quality and safety. This…