rCR Implementation Guide for PyroSmart NextGen

This guide serves as a comprehensive resource for the implementation of the recombinant Cascade Reagent (rCR) known as PyroSmart NextGen® (PSNG) for endotoxin testing. It is specifically designed for quality control managers, regulatory affairs professionals, and sustainability officers. The document outlines the necessity of adopting PSNG in quality control systems, emphasizing its regulatory acceptance under the new US Pharmacopeia Chapter <86>. The guide details the benefits of PSNG, including its non-animal derived nature, sustainability, and technical advancements over traditional Limulus Amebocyte Lysate (LAL) reagents. It provides a structured approach for implementation, including user requirements, necessary equipment, risk analysis, and step-by-step instructions for transitioning to PSNG. The document also discusses the compatibility of PSNG with existing photometric platforms and the importance of training for effective usage. Overall, this guide aims to facilitate the adoption of PSNG in endotoxin testing processes while ensuring compliance with regulatory standards.