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This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force. PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version …

PDA Technical Report 14, Revised 2008, Validation of Column-Based Chromatography Processes for the Purification of Proteins was prepared by members of the PDA Validation of Column-Based Chromatography Processes for the Purification of Proteins Task Force. Since publication of the original Technical …

This Technical Report was prepared by Lubrication of Packaging Components Task Force. The purpose for this publication is to present information. This document reviews the common lubricants, the reasons for their use, methods of application and analytical measurement. Available to download Format: PDF …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by the Radiation Sterilization Task Force Members. It provides general information concerning …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This paper, written by Drs. John Wang and Musetta Hanson, is a review of concerns in formulating injectable products containing …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical report, the result of a grant to Julius Knapp and Patrick DeLuca, Ph.D., describes the various types of particulate …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by PDA Depyrogenation Subcommittee.The Depyrogenation report consists of 14 chapters, …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by Dr. Y. John Wang and Dr. Yie W. Chien under the auspices of the PDA Research …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by the QC Subcommittee of the PDA Research Committee. This publication outlines methods …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical report by PDA`s Bioburden Recovery Validation Task Force discusses the importance of validating bioburden …

PDA Technical Report 38, Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing and Controls Documentation, prepared by the PDA Manufacturing Chromatography Systems PAC Task Force. This Technical Report addresses post-approval changes to drug substance …

The first report, Sterilizing Filtration of Gases, is prepared by PDA Sterile Gas Filtration Committee. The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration …

The first report, Sterilizing Filtration of Gases, is prepared by PDA Sterile Gas Filtration Committee. The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration …

PDA's original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist …

PDA has revised Technical Report No. 3, originally issued in 1981. The revision offers a modern, scientific approach to dry-heat depyrogenation and sterilization processes and includes recommendations for use by industry and regulators. References to appropriate and current scientific publications, international …

It has been 14 years since PDA published the original Technical Report No. 29, and cleaning validation continues to play an important role in reducing the possibility of product contamination from pharmaceutical manufacturing equipment. Cleaning validation demonstrates that the cleaning process adequately …

This Technical Report was prepared by members of the PDA Filtration of Liquids Using Cellulose-Based Depth Filters Task Force. This technical report was written to provide guidelines for the selection, validation and use of cellulose-based depth filters in pharmaceutical and biopharmaceutical …

The first report, Sterilizing Filtration of Gases, is prepared by PDA Sterile Gas Filtration Committee. The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration …

This Technical Report was prepared by the Joint PDA/PhRMA Sterile Bulk Pharmaceutical Chemicals Task Force. This document provides guidance relative to the validation of aseptic processing activities utilized for the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts …

This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force. PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version …