Tag: Utilities & Support System Validation

Writing a Clean Steam Validation Protocol

Writing a Clean Steam Validation Protocol Writing a Clean Steam Validation Protocol In the pharmaceutical and biotechnology industries, maintaining sterile conditions is critical. This is particularly true for facilities utilizing clean steam systems, especially those operating under ISO 1 clean…

Regulatory Expectations for Steam Sterilization Systems

Regulatory Expectations for Steam Sterilization Systems Regulatory Expectations for Steam Sterilization Systems Steam sterilization is a critical process in pharmaceutical manufacturing, ensuring product safety and compliance with applicable regulatory standards. In this detailed tutorial, we outline the essential steps for…

Thermocouple Placement Strategy for Steam Validation

Thermocouple Placement Strategy for Steam Validation Thermocouple Placement Strategy for Steam Validation The validation of steam sterilization processes is critical in ensuring the safety and efficacy of pharmaceutical products. This step-by-step tutorial will guide QA, QC, Validation, and Regulatory teams…

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…

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…

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…

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 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…

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…

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.…