Tag: Utilities & Support System Validation

Steam Quality Tests: Non-condensable Gases, Superheat, Dryness

Steam Quality Tests: Non-condensable Gases, Superheat, Dryness Steam Quality Tests: Non-condensable Gases, Superheat, Dryness In the pharmaceutical industry, the validation of steam systems is crucial for ensuring safe and efficient sterilization processes. This article will present a step-by-step tutorial on…

How to Validate Clean Steam Generators and Distribution Lines

How to Validate Clean Steam Generators and Distribution Lines How to Validate Clean Steam Generators and Distribution Lines In the pharmaceutical industry, clean steam generators and their distribution lines play a crucial role in ensuring the integrity of products and…

Acceptable Limits for Microbial Load in Compressed Gases

Acceptable Limits for Microbial Load in Compressed Gases Acceptable Limits for Microbial Load in Compressed Gases In the pharmaceutical industry, compressed gases such as air and nitrogen play a vital role in various processes, including manufacturing and laboratory testing. This…

Common Gaps Found During Gas System Audits

Common Gaps Found During Gas System Audits Common Gaps Found During Gas System Audits This article provides a comprehensive, step-by-step guide on identifying and addressing common gaps found during gas system audits, specifically focusing on compliance with EU GMP Annex…

Gas System Data Logging and Electronic Recordkeeping

Gas System Data Logging and Electronic Recordkeeping Gas System Data Logging and Electronic Recordkeeping The validation of gas systems is a crucial aspect of pharmaceutical manufacturing. These systems ensure that the gases used in processes such as wet transfer western…

Regulatory Requirements for Qualification of Cleanroom Gases

Regulatory Requirements for Qualification of Cleanroom Gases Regulatory Requirements for Qualification of Cleanroom Gases The qualification of cleanroom gases is an integral part of the validation lifecycle in the pharmaceutical and biotechnology industries. Ensuring that gases such as compressed air,…

Impact of Gas Contamination on Product Quality

Impact of Gas Contamination on Product Quality Impact of Gas Contamination on Product Quality In the pharmaceutical and biotech industries, ensuring the quality of products is paramount. Contamination from gases, especially in processes reliant on compressed air or nitrogen, can…

Filter Validation in Compressed Air and Nitrogen Systems

Filter Validation in Compressed Air and Nitrogen Systems Filter Validation in Compressed Air and Nitrogen Systems Filter validation plays a critical role in ensuring the integrity and quality of compressed air and nitrogen systems used in pharmaceutical and biologics manufacturing.…

Alarm and Interlock Testing for Gas Supply Systems

Alarm and Interlock Testing for Gas Supply Systems Alarm and Interlock Testing for Gas Supply Systems In the pharmaceutical industry, ensuring the reliability and safety of gas supply systems is critical for maintaining compliance with Good Manufacturing Practices (GMP). This…

Risk Assessment Template for Pharmaceutical Gases

Risk Assessment Template for Pharmaceutical Gases Risk Assessment Template for Pharmaceutical Gases In the pharmaceutical industry, the validation of gases such as compressed air and nitrogen is critical to maintaining product quality, safety, and compliance with regulatory standards. This step-by-step…