Utilities & Support System Validation

PQ Testing Schedule for Newly Installed Water Loops

PQ Testing Schedule for Newly Installed Water Loops PQ Testing Schedule for Newly Installed Water Loops The validation lifecycle for newly installed water loops is critical to ensure compliance with regulatory standards and operational effectiveness. This article aims to provide…

Differences in Validating Non-Compendial vs Compendial Water

Differences in Validating Non-Compendial vs Compendial Water Differences in Validating Non-Compendial vs Compendial Water In the pharmaceutical industry, ensuring the quality of water systems—whether compendial or non-compendial—is critical for product safety, efficacy, and compliance with regulatory standards. This article provides…

Validating Compressed Air Systems in Pharma Manufacturing

Validating Compressed Air Systems in Pharma Manufacturing Validating Compressed Air Systems in Pharma Manufacturing This article provides a comprehensive, step-by-step tutorial on the validation of compressed air systems utilized in pharmaceutical manufacturing. It outlines the validation lifecycle, including process design,…

ISO 8573 Compliance Testing for Pharmaceutical Gases

ISO 8573 Compliance Testing for Pharmaceutical Gases ISO 8573 Compliance Testing for Pharmaceutical Gases: A Comprehensive Step-by-Step Validation Tutorial In the pharmaceutical industry, ensuring the quality of compressed gases is essential for compliance with regulatory standards and product integrity. ISO…

Microbial, Particulate, and Oil Testing in Compressed Air

Microbial, Particulate, and Oil Testing in Compressed Air Microbial, Particulate, and Oil Testing in Compressed Air The validation of compressed air systems in pharmaceutical and biologics manufacturing is crucial for ensuring quality and compliance with regulatory standards such as ISO…

Compressed Nitrogen Qualification for Use in Cleanrooms

Compressed Nitrogen Qualification for Use in Cleanrooms Compressed Nitrogen Qualification for Use in Cleanrooms In the pharmaceutical and biologics sectors, the qualification of utility gases, such as compressed nitrogen, is critical to ensure compliance with rigorous regulatory expectations aimed at…

Flow, Pressure, and Dew Point Testing in Gas Systems

Flow, Pressure, and Dew Point Testing in Gas Systems Flow, Pressure, and Dew Point Testing in Gas Systems In the pharmaceutical sector, ensuring the integrity and reliability of gas systems is critical for compliance with regulatory standards. Specifically, ISO 14644-1:2015…

Sampling Points and Frequency for Gases in Controlled Areas

Sampling Points and Frequency for Gases in Controlled Areas Sampling Points and Frequency for Gases in Controlled Areas In the context of pharmaceutical manufacturing, the validation of gases in controlled areas is a critical element of ensuring product quality and…

Gas Distribution Loop Qualification: What to Include

Gas Distribution Loop Qualification: What to Include Gas Distribution Loop Qualification: What to Include Gas distribution loops, comprising systems like compressed air and nitrogen supply, play a crucial role in pharmaceutical manufacturing. Qualifying these systems ensures compliance with regulatory requirements,…

SOP for Purging and Sanitizing Compressed Gas Lines

SOP for Purging and Sanitizing Compressed Gas Lines SOP for Purging and Sanitizing Compressed Gas Lines This comprehensive guide is designed for pharmaceutical professionals involved in the validation lifecycle concerning the purging and sanitizing of compressed gas lines. It emphasizes…