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Cleanroom Microbiology (single user digital version)
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While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled … -
Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes (single user digital version)
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Sale - 20% off! Original Price US$210 PDA Member, US$259 Nonmember, US$170 Government Sale prices are already displayed and will be reflected during checkoutThe goal of Lynn and Joyce Torbeck's book, Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes, is to … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volumes 1, 2 & 3 (single user digital version)
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Sale - 20% off! Original Price US$635 PDA Member, US$790 Nonmember, US$435 Government Sale prices are already displayed and will be reflected during checkoutThe three volumes Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and … -
Contamination Control in Healthcare Product Manufacturing, Volumes 1, 2 & 3 (single user digital version)
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50 global subject matter experts share their broad experience in all aspects of healthcare product manufacturing contamination control in this three-volume set.The first volume of Contamination Control contained chapters that are predominantly centered on microbial issues. Volume 2 addresses some microbial … -
Contamination Control in Healthcare Product Manufacturing, Volume 2 (single user digital version)
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Contamination Control in Healthcare Product Manufacturing, Volume 2, edited by Russell E. Madsen and Jeanne Moldenhauer, Volume 2 addresses some microbial control issues as well as other types of contamination. These valuable chapters will provide a great deal of information in your arsenal for contamination … -
Contamination Control in Healthcare Product Manufacturing, Volume 3 (single user digital version)
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Volume 3 discusses extensive subjects related to water considerations and also includes invaluable advice regarding ventilation systems, the microbiology laboratory, mold, microaerophillics, Burholderia cepacia, a life cycle approach to cleaning validation, extensive coverage of risk management with … -
Sources and Control of Contamination (single user digital version)
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Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFacility Design and Control: Personnel by Anne Marie Dixon. Chapter excerpted from Volume 1, Chapter 5 published May 2013. Fungal and Bacterial … -
Cleaning and Disinfection (single user digital version)
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Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFacility Design and Control: Cleaning and Sanitization by Anne Marie Dixon. Chapter excerpted from Volume 1, Chapter 6 published May … -
Mold and Fungal Contamination (single user digital version)
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Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFungal and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol Bartnett and Dan Klein. Chapter excerpted from Volume … -
Cleaning Agents and Cleaning Chemistry (single user digital version)
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This chapter is taken from the book Cleaning and Cleaning Validation, Volume 1Here is a cogent, informed discussion written to help multi-product facilities meet the safety and regulatory requirements related to cleaning agents and cleaning chemistry.Available to download. Prior to purchase please view … -
PDA Technical Series: Sterilization — Compilation of Technical Reports and Journal Articles on Pharmaceutical Sterilization (single user digital version)
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Over the years, PDA expert task forces have developed several technical reports on moist and dry heat sterilization processes. In addition, experts in the PDA community of published several articles on these topics and alternative sterilization methods in the PDA Journal of Pharmaceutical Science and … -
Contamination Control in Healthcare Product Manufacturing, Volume 1 (single user digital version)
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Contamination Control in Healthcare Product Manufacturing, Volume 1, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use … -
PDA Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (single user digital version)
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Provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical … -
PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods (single user digital version)
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Intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. This technical report was written to establish industry-wide … -
PDA Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization (single user digital version)
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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 … -
PDA Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes (single user digital version)
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The purpose of this technical report is to outline methods and approaches for control and evaluation of aseptic processing operations for drug products/medicinal products which use all or partially manual procedures. This technical report has value for hospital and formulation pharmacies where manual … -
PDA Technical Report No. 54-2(TR 54-2) Implementation of Quality Risk Management for Pharmaceutical & Biotechnology Manufacturing Operation:Annex 1: Case Study Examples for Quality Risk Management in Packaging & Labeling (single user digital version)
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The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides specific case studies on how to apply quality risk management (QRM) to pharmaceutical manufacturing, specifically packaging and labeling … -
PDA Technical Report No. 61 (TR 61) Steam In Place
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This technical report complements PDA Technical Report No. 1 (Revised 2007): Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control with a focus on steam-in-place (SIP) processes. The primary objective of the task force responsible for this technical … -
PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation (single user digital version)
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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 … -
Steam Sterilization Process Validation (single user digital version)
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This chapter is taken from the book Thermal Validation in Moist Heat SterilizationThe manufacture of many pharmaceutical products includes sterilization processes intended to eliminate microbial contamination. This document will review the validation requirements associated with moist heat sterilization …
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