Category: Biologics & Biosimilars

Chromatography System Cleaning Validation Protocol and Acceptance Criteria for Reusable Flow Paths in Biologics & Biosimilars Chromatography System Cleaning Validation Protocol for Reusable Flow Paths in Biologics and Biosimilars Manufacturing Purpose and Scope This protocol establishes the foundational framework for…

Tangential Flow Filtration System Reusable Flow Paths Cleaning Validation Protocol and SOP Cleaning Validation Protocol and Procedure for Tangential Flow Filtration System with Reusable Flow Paths in Biologics Manufacturing Purpose and Scope This document establishes a standardized cleaning validation protocol…

Aseptic Filling Isolator Product Path Components Cleaning Validation Protocol and Acceptance Criteria Cleaning Validation Protocol and Procedure for Aseptic Filling Isolator Product Path Components in Biologics & Biosimilars Manufacturing Purpose and Scope This document establishes the cleaning validation protocol and…

Comprehensive Protocol for Virus Filtration System (Reusable Components) Cleaning Validation Comprehensive Cleaning Validation Protocol for Virus Filtration Systems with Reusable Components in Biologics & Biosimilars Manufacture Purpose and Scope The purpose of this protocol is to establish a comprehensive cleaning…

Transfer Lines and Manifolds (Reusable) Cleaning Validation Protocol and Acceptance Criteria for Biologics & Biosimilars Cleaning Validation Protocol and Standard Operating Procedure for Transfer Lines and Manifolds (Reusable) in Biologics & Biosimilars Manufacturing Purpose and Scope This document establishes a…

Reusable Mixing / Holding Vessel (Biologics) Cleaning Validation Protocol and Acceptance Criteria Cleaning Validation Protocol and Procedure for Reusable Mixing and Holding Vessels in Biologics Manufacturing Purpose and Scope This Cleaning Validation Protocol and Standard Operating Procedure (SOP) details the…