Standard Practice for Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products
€72.00
Standard Terminology for Combination Products (Drug/Medical Device/Biologic Combinations)
€65.00
Standard Practice for Reporting the Counts, Sizes, and Types of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
Standard Classification for Reporting Particle Contamination and Insoluble Droplets in Water and other Pharmaceutical Fluids When Analyzed by Direct Imaging Analyzers
€58.00
Standard Practice for Qualification of Procedures for the Extraction of Particulate Matter from the Surfaces of Single-Use Bioprocessing Equipment
Standard Guide for Critical Airflow Visualization
Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
Standard Guide for Development and Validation Considerations of Advanced Process Control (APC) in Commercial Pharmaceutical Manufacturing
Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices
€94.00
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach
Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
Standard Practice for Validation of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
Standard Guide for Development of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
