Steam System Validation

Pure Steam & Clean Steam Validation: Quality, Sampling & Testing Guidelines

Pure Steam & Clean Steam Validation: Quality, Sampling & Testing Guidelines Pure Steam & Clean Steam Validation: Quality, Sampling & Testing Guidelines Steam is a critical utility in pharmaceutical manufacturing, especially for sterilization, SIP (Sterilization-in-Place), and cleaning. When steam directly…

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…

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…

IQ/OQ/PQ of Pure Steam Systems in Pharma Plants

<title IQ/OQ/PQ of Pure Steam Systems in Pharma Plants IQ/OQ/PQ of Pure Steam Systems in Pharma Plants In the pharmaceutical industry, the validation of utilities such as pure steam systems is a critical component of ensuring product safety and efficacy.…

Sampling Techniques for Steam Condensate Analysis

Sampling Techniques for Steam Condensate Analysis Sampling Techniques for Steam Condensate Analysis In the pharmaceutical industry, validating analytical procedures is critical to ensure the accuracy and reliability of results, especially when dealing with utilities like steam systems. This article presents…

Steam Trap Qualification and Preventive Maintenance

Steam Trap Qualification and Preventive Maintenance Steam Trap Qualification and Preventive Maintenance In the pharmaceutical and biotech industries, ensuring the integrity of steam systems is critical for compliance with Good Manufacturing Practices (GMP) as outlined by regulatory agencies like the…

Heat Distribution and Mapping in Steam Autoclaves

Heat Distribution and Mapping in Steam Autoclaves Heat Distribution and Mapping in Steam Autoclaves Heat distribution and mapping in steam autoclaves are critical validation processes for ensuring the reliability of sterilization procedures in the pharmaceutical industry. This comprehensive guide will…

Steam-in-Place (SIP) Cycle Validation: Critical Parameters

Steam-in-Place (SIP) Cycle Validation: Critical Parameters Steam-in-Place (SIP) Cycle Validation: Critical Parameters Validation of steam-in-place (SIP) cycles is a critical aspect of process validation within pharmaceutical and biologics manufacturing. This comprehensive step-by-step guide focuses on the important parameters to consider…

Condensate Return System Qualification and Monitoring

Condensate Return System Qualification and Monitoring Condensate Return System Qualification and Monitoring Condensate Return System Qualification and Monitoring – Practical guide for pharma professionals on test method validation with GMP, FDA and EMA compliance. Step 1: Understanding User Requirements Specification…

Bio-Burden and Endotoxin Control in Clean Steam

Bio-Burden and Endotoxin Control in Clean Steam Bio-Burden and Endotoxin Control in Clean Steam In pharmaceutical and biologics manufacturing, managing bio-burden and endotoxin levels is crucial, particularly when dealing with clean steam systems. This article provides a comprehensive, step-by-step validation…