Utilities & Support System Validation

Steam Contact Surface Compatibility and Corrosion Risk

Steam Contact Surface Compatibility and Corrosion Risk Steam Contact Surface Compatibility and Corrosion Risk In the pharmaceutical industry, maintaining the integrity of cleanroom environments is paramount. The adherence to ISO 14644-1 cleanroom standards ensures that cleanrooms remain uncontaminated and conducive…

PQ for SIP of Bioreactors and Fermenters

PQ for SIP of Bioreactors and Fermenters PQ for SIP of Bioreactors and Fermenters This article serves as a comprehensive guide for pharmaceutical professionals on the validation of Steam-In-Place (SIP) systems utilized in bioreactors and fermenters. It aims to provide…

Audit Trail for Steam System Validation Activities

Audit Trail for Steam System Validation Activities Audit Trail for Steam System Validation Activities In the pharmaceutical and biologics sectors, validation of steam systems is critical to ensure product quality and compliance with stringent regulatory requirements. This step-by-step tutorial covers…

Common Deviations and Failures in Steam Validation

Common Deviations and Failures in Steam Validation Common Deviations and Failures in Steam Validation Effective validation of steam systems is crucial for compliance with regulatory requirements and ensuring the quality of pharmaceutical products. This step-by-step tutorial outlines the validation lifecycle,…

Utility Loop Mapping for Validation: Best Practices

Utility Loop Mapping for Validation: Best Practices Utility Loop Mapping for Validation: Best Practices Utility loop mapping is a critical process validation activity within the pharmaceutical and biopharmaceutical industries. It ensures that the utilities supporting the manufacturing process function as…

Pressure Drop Testing in Utility Distribution Lines

Pressure Drop Testing in Utility Distribution Lines Pressure Drop Testing in Utility Distribution Lines Pressure drop testing in utility distribution lines is a vital component of ensuring the integrity and functionality of cleanrooms within the pharmaceutical industry. This detailed tutorial…

How to Perform Thermal Mapping of Utility Lines

How to Perform Thermal Mapping of Utility Lines How to Perform Thermal Mapping of Utility Lines The process of thermal mapping utility lines is critical in ensuring that the temperatures throughout controlled environments, such as cleanrooms, meet the regulatory requirements…

Dead Leg Identification and Correction in Utility Systems

Dead Leg Identification and Correction in Utility Systems Dead Leg Identification and Correction in Utility Systems The identification and correction of dead legs in utility systems are crucial for maintaining regulatory compliance, ensuring product quality, and safeguarding patient safety in…

Validation Strategy for Complex Utility Networks

Validation Strategy for Complex Utility Networks Validation Strategy for Complex Utility Networks Validation of complex utility networks is paramount in maintaining the integrity and compliance of pharmaceutical manufacturing processes. This comprehensive guide delineates a methodical approach to cleaning validation, emphasizing…

Instrumentation Mapping in Utility Qualification Protocols

Instrumentation Mapping in Utility Qualification Protocols Instrumentation Mapping in Utility Qualification Protocols Instrumentation mapping is a crucial aspect of validating utility qualification protocols in the pharmaceutical and biotech sectors, particularly when ensuring compliance with ISO 14644-4, EUDRALEX Annex 11, and…