Stability & Compatibility with Packaging

Packaging System Compatibility with Product Stability: A Complete Guide

Packaging System Compatibility with Product Stability: A Complete Guide Packaging System Compatibility with Product Stability: A Complete Guide Step 1: Define User Requirements Specification (URS) and Perform Risk Assessment In the context of packaging system validation, initiating the validation lifecycle…

How to Perform Light Transmission and Moisture Permeation Testing

How to Perform Light Transmission and Moisture Permeation Testing How to Perform Light Transmission and Moisture Permeation Testing 1. Understanding User Requirements and Risk Assessment The first step in the validation lifecycle of light transmission and moisture permeation testing is…

Simulating Transportation Conditions for Packaging-Product Stability

Simulating Transportation Conditions for Packaging-Product Stability Simulating Transportation Conditions for Packaging-Product Stability The validation of packaging systems is critical in ensuring the stability and integrity of pharmaceutical products throughout their lifecycle, particularly during transportation. This article provides a comprehensive, step-by-step…

Accelerated vs Long-Term Stability Protocols Linked to Packaging

Accelerated vs Long-Term Stability Protocols Linked to Packaging Accelerated vs Long-Term Stability Protocols Linked to Packaging In the pharmaceutical industry, ensuring the long-term stability and integrity of products is paramount. Stability testing protocols, both accelerated and long-term, are critical components…

Stability Failures Due to Packaging Migration: Root Cause Analysis

Stability Failures Due to Packaging Migration: Root Cause Analysis Stability Failures Due to Packaging Migration: Root Cause Analysis Stability failures often occur within pharmaceutical and medical device manufacturing, particularly when there are interactions between the product and its packaging materials.…

Drug-Container Interaction Testing and Leachable Assessment

Drug-Container Interaction Testing and Leachable Assessment Drug-Container Interaction Testing and Leachable Assessment In the pharmaceutical industry, ensuring the integrity and efficacy of drug products throughout their shelf life is paramount. A crucial aspect of this assurance lies in understanding the…

Validating Child-Resistant and Senior-Friendly Packaging

Validating Child-Resistant and Senior-Friendly Packaging Validating Child-Resistant and Senior-Friendly Packaging The validation of child-resistant and senior-friendly packaging is vital for safeguarding vulnerable populations while ensuring product integrity. Following the ISO 11137-1 guidelines and regulatory expectations from the FDA, EMA, and…

Compatibility Studies for High-Humidity and Cold Storage Zones

Compatibility Studies for High-Humidity and Cold Storage Zones Compatibility Studies for High-Humidity and Cold Storage Zones In the pharmaceutical and medical device industries, ensuring that products maintain their integrity and effectiveness under various environmental conditions is critical. This involves rigorous…

How to Document Packaging Justification in Regulatory Filings

How to Document Packaging Justification in Regulatory Filings How to Document Packaging Justification in Regulatory Filings In the highly regulated environment of the pharmaceutical industry, proper documentation of packaging justification is pivotal for ensuring compliance with various guidelines, including those…

Packaging Material Change Impact on Shelf Life Claims

Packaging Material Change Impact on Shelf Life Claims Packaging Material Change Impact on Shelf Life Claims In the pharmaceutical industry, maintaining product integrity and ensuring that shelf life claims are substantiated is critical for regulatory compliance and consumer safety. A…