Tag: Compressed Air

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…

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…

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…

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…

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…

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,…