Validations: Closed Systems, Single-Use & Aseptic Controls
Pre-Use/Post-Sterilization Integrity Tests (PUPSIT) Essentials Pre-Use/Post-Sterilization Integrity Tests (PUPSIT) Essentials The pharmaceutical industry continuously seeks to enhance the safety, quality, and efficacy of biologics and advanced therapy medicinal products (ATMPs). One of the fundamental aspects governing the production of these therapies is ensuring sterilization and integrity, particularly in closed and single-use systems. This guide comprehensively covers the essentials of Pre-Use/Post-Sterilization…
Pre-Use/Post-Sterilization Integrity Tests (PUPSIT) Essentials Pre-Use/Post-Sterilization Integrity Tests (PUPSIT) Essentials In the realm of biologics and advanced therapy medicinal products (ATMPs), ensuring the efficacy and safety of sterile products is paramount. Pre-Use/Post-Sterilization Integrity Tests (PUPSIT) play a crucial role in this context, specifically in closed systems and single-use systems. This guide delves into the essentials of PUPSIT, focusing on regulatory…
Connection Technologies: Aseptic, Steam-to, and Welded Connection Technologies: Aseptic, Steam-to, and Welded Introduction to Aseptic Connection Technologies Aseptic connection technologies are crucial in the pharmaceutical and biotechnological industries, particularly when dealing with biologics and Advanced Therapy Medicinal Products (ATMPs). The current regulatory landscape—encompassing guidelines from the FDA, EMA, MHRA, and PIC/S—emphasizes the importance of stringent controls and methodologies to ensure…
Connection Technologies: Aseptic, Steam-to, and Welded 1. Introduction to Aseptic Connection Technologies in Biologics Aseptic connection technologies play a critical role in the production of biologics, particularly in the context of viral clearance validation and maintaining the integrity of closed systems and single-use systems. With the increasing complexity of biologics manufacturing, professionals are tasked with ensuring stringent aseptic controls that…
Closed System Design: Mapping Open-to-Closed Opportunities The advancement of biologics and advanced therapies medicinal products (ATMPs) mandates thorough validation processes to ensure their safety and efficacy. A key aspect of this validation is maintaining the integrity of the closed systems and aseptic controls involved. Closed System Design focuses on mapping the transition from open systems to closed environments to mitigate…
Single-Use System Qualification: Extractables/Leachables Hooks Single-Use System Qualification: Extractables/Leachables Hooks In the rapidly evolving landscape of biologics and Advanced Therapy Medicinal Products (ATMPs), the complexity of validations surrounding single-use systems (SUS) is paramount. This article guides pharmaceutical professionals through the necessary steps to ensure effective extractables/leachables (E&L) assessments as part of the qualification and validation of single-use systems. It will…
Aseptic Controls for ATMP: Annex 1 Expectations Aseptic Controls for ATMP: Annex 1 Expectations Advanced therapy medicinal products (ATMPs) have revolutionized the therapeutic landscape, offering significant promise in treating diseases that were previously deemed incurable. The regulatory environment surrounding ATMPs, particularly concerning aseptic processing controls, is intricate and defined by stringent guidelines. The Annex 1 of the EudraLex covers the…