Tag: Primary Packaging Component Validation

Extractables and Leachables Testing for Primary Containers

Extractables and Leachables Testing for Primary Containers Extractables and Leachables Testing for Primary Containers Extractables and Leachables (E&L) testing is critical in ensuring the safety and efficacy of pharmaceutical products packaged in primary containers. The reliable assessment of E&L helps…

Rubber Stopper and Aluminum Seal Qualification Protocol

Rubber Stopper and Aluminum Seal Qualification Protocol Rubber Stopper and Aluminum Seal Qualification Protocol Rubber stopper and aluminum seal qualification are critical in ensuring the integrity and safety of pharmaceutical packaging. This article serves as a comprehensive step-by-step validation tutorial…

Visual Inspection Standards for Defect-Free Primary Packaging

Visual Inspection Standards for Defect-Free Primary Packaging Visual Inspection Standards for Defect-Free Primary Packaging Ensuring the integrity and safety of pharmaceutical products is paramount within the industry, particularly concerning the primary packaging components. This article provides a comprehensive step-by-step validation…

How to Perform Dimensional Testing of Primary Packaging Components

How to Perform Dimensional Testing of Primary Packaging Components How to Perform Dimensional Testing of Primary Packaging Components Dimensional testing of primary packaging components is critical in ensuring compliance with regulatory standards such as ISO 11135, ISO 14644, and ISO…

Container-Closure Integrity (CCI) Testing: Methods & Acceptance Criteria

Container-Closure Integrity (CCI) Testing: Methods & Acceptance Criteria Container-Closure Integrity (CCI) Testing: Methods & Acceptance Criteria Container-Closure Integrity (CCI) testing is a critical component in ensuring the safety and efficacy of pharmaceutical products. This article provides a comprehensive, step-by-step validation…

Validating Vials, Ampoules, and Bottles in Pharma Packaging

Validating Vials, Ampoules, and Bottles in Pharma Packaging Validating Vials, Ampoules, and Bottles in Pharma Packaging Validating the primary packaging components, such as vials, ampoules, and bottles, is a critical aspect of the pharmaceutical manufacturing process. This comprehensive guide focuses…