Validations: Biologics, ATMP & Viral Safety Validation
Environmental Monitoring for Closed Systems Environmental Monitoring for Closed Systems Introduction to Environmental Monitoring in Closed Systems In the highly regulated environment of pharmaceutical manufacturing, especially in the production of biologics and Advanced Therapy Medicinal Products (ATMPs), environmental monitoring plays a crucial role in ensuring the safety and efficacy of the products being developed. The implementation of stringent aseptic controls…
Decontamination: VHP/HPV in ATMP Facilities Decontamination: VHP/HPV in ATMP Facilities Advanced Therapy Medicinal Products (ATMPs) are at the forefront of biopharmaceutical innovation, requiring stringent bioburden and viral safety controls to ensure patient safety. One critical component of maintaining sterility in ATMP facilities is decontamination, particularly through the use of Vaporized Hydrogen Peroxide (VHP) and Hydrogen Peroxide Vapor (HPV) methods. This…
Automation/SCADA Controls in Closed Systems Introduction to Closed Systems and Aseptic Controls The pharmaceutical industry has seen a considerable shift toward the implementation of closed systems and single-use technologies, especially in biologics and advanced therapy medicinal products (ATMPs). These systems serve as a critical component in ensuring product sterility and compliance with aseptic controls outlined in regulatory guidelines such as…
Material Transfer Controls: Gowning and Pass-Throughs Material Transfer Controls: Gowning and Pass-Throughs Introduction to Material Transfer Controls Material transfer controls are essential for maintaining the integrity of the manufacturing process in the pharmaceutical and biopharmaceutical sectors, particularly in the context of aseptic processing of Advanced Therapy Medicinal Products (ATMP). Compliance with regulatory requirements set forth by authorities such as the…
Integrity Testing for Single-Use: Bags, Tubing, and Connectors Integrity Testing for Single-Use: Bags, Tubing, and Connectors Introduction to Integrity Testing The integration of single-use systems into biopharmaceutical manufacturing has transformed traditional processes, enhancing flexibility, efficiency, and reducing contamination risk. Among the critical aspects of these systems is integrity testing, which ensures functional integrity and sterility of components such as bags,…
Integrity Testing for Single-Use: Bags, Tubing, and Connectors In modern biopharmaceutical manufacturing, the shift toward single-use systems (SUS) presents unique challenges and opportunities in the domain of integrity testing. This comprehensive guide will walk you through the essential protocols for testing the integrity of single-use bags, tubing, and connectors, focusing on aseptic controls and viral clearance validation, which are critical…
SU Manifolds: Assembly, Sterilization, and Traceability SU Manifolds: Assembly, Sterilization, and Traceability 1. Introduction to SU Manifolds in Pharmaceutical Validation The pharmaceutical industry is rapidly evolving, especially with the increasing demand for biologics and advanced therapy medicinal products (ATMPs). A critical aspect of producing these products is the use of single-use (SU) manifolds in aseptic processes. These systems facilitate the…
SU Manifolds: Assembly, Sterilization, and Traceability The validation of single-use (SU) manifolds is an essential component in the development of biologics, advanced therapy medicinal products (ATMPs), and other pharmaceutical formulations. The integration of these systems into aseptic processes requires rigorous attention to detail, from assembly through to sterilization and traceability. This article is designed as a comprehensive tutorial for professionals…
SIP/Sterilization Links in Hybrid (SU + SS) Plants SIP/Sterilization Links in Hybrid (SU + SS) Plants In the complex landscape of biologics and Advanced Therapy Medicinal Products (ATMP) validation, understanding the role of aseptic controls within hybrid Single-Use (SU) and Stainless Steel (SS) systems is critical. This step-by-step guide will delve into the nuances of viral clearance validation, spiking studies,…
SIP/Sterilization Links in Hybrid (SU + SS) Plants As the demand for biologics, advanced therapy medicinal products (ATMPs), and viral safety continues to evolve, the pharmaceutical industry faces unique challenges in ensuring compliance with regulatory standards. This tutorial provides a comprehensive guide to the validation of sterilization in hybrid (single-use and stainless steel) plants, focusing on aseptic processing, viral clearance…