Pharmaceutical Particle Counting Papers
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Basic Guide to Particle Counters and Particle Monitoring (441.3 KB) This overview of particle contamination starts by discussing sources of contamination and monitoring technologies available, and continues by discussing various... Download above file for full tables and figures, or for overview, see HTML Version. |
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Technical Review: Particle Counting to Meet European GMP Annex 1, 2008 edition (709.0 KB) Read this technical summary of the updated particle monitoring recommendations in the 2008 EU GMP Annex 1. This paper discusses why the new Annex was needed, and how to comply. Download above file for full tables and figures, or for overview, see HTML Version. |
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EU GMP 5 µm Particle Counter Limits Advice (860.1 KB) There is a common industry misconception that 1m3 particle monitoring should be performed...(download file to continue to learn more) Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Counters for Pharmaceutical Cleanrooms (381.5 KB) This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to... Download above file for full tables and figures, or for overview, see HTML Version. |
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This review document has been approved by the ISPE. To learn more about GAMP or to place an order, visit www.ispe.org Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Counters for Injectable Solutions, 2007 USP Update (244.3 KB) Learn about the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards, including the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that... Download above file for full tables and figures, or for overview, see HTML Version. |
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An Analysis of Acceptable Losses in Tubing to Particle Counters (231.8 KB) When the validation implications of losses due to various forces are reviewed, the certainty of the result is always in question. What are these forces, the losses, and acceptable results? Download above file for full tables and figures, or for overview, see HTML Version. |
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Quick Steps to Meet USP 797 Compliance (203.5 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Planning and Installing an Environmental Particle Monitoring System (489.4 KB) For aseptic manufacture of pharmaceutical products, there has been a shift, primarily due to legislative regulations. New regulations have led to a requirement for an automated, remote monitoring solution. This paper reviews the various steps for the implementation of ... Download above file for full tables and figures, or for overview, see HTML Version. |
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GMP Update Summary - Particle Monitoring To Meet FDA and EU GMP Requirements (592.5 KB) Several changes have occurred that have brought an elevated review of practices with regard to non-viable particle monitoring, specifically the FDA Guideline on Aseptic Manufacture and the EU GMP Annex 1. Download above file for full tables and figures, or for overview, see HTML Version. |
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Summary for USP 797 Operating Docs - Complete Document provided with Handilaz Mini Purchase (64.6 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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The FDA requires human cell, tissue, and cellular and tissue-based product establishments to follow the current Good Tissue Practice (GTP), which governs the methods used in, and the facilities and controls used for, the manufacture of human tissue and cellular and tissue-based products. The 21 CFR Part 1271 regulation was enforced as of May 25, 2005... Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Measuring Systems' Software and GAMP® 21 CFR Part 11 Compliance (92.9 KB) Pharmaceutical companies have historically submitted product applications to the Food and Drug Administration (FDA) on paper. With the advent of technology this is now dominated with electronic data records and electronic submissions. This change in philosophy has meant that in the FDA's... Download above file for full tables and figures, or for overview, see HTML Version. |
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Vaporous Hydrogen Peroxide Measurements in an Isolator Using Ion Mobility Spectrometry (4.0 MB) Download above file for full tables and figures, or for overview, see HTML Version. |
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USP 797 Particle Monitoring (603.8 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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How Many Particles, How Much Sample Volume? (254.3 KB) How many particles are needed to demonstrate statistical confidence for cleanroom control and how much sample volume is required to see them? Download above file for full tables and figures, or for overview, see HTML Version. |
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GAMP® Good Practice Guide: Calibration Management Technical Document Review (145.9 KB) This review document has been approved by the ISPE. To learn more about GAMP or to place an order, visit www.ispe.org Download above file for full tables and figures, or for overview, see HTML Version. |
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Download above file for full tables and figures, or for overview, see HTML Version. |
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Process Analytical Technologies (PAT) and Non-viable Particle Counting (116.7 KB) Pharmaceutical manufacturing environments have traditionally seen particle counting as a necessary evil to demonstrate compliance to a cleanrooms standard. Now, however, Process Analytical Technologies (PAT) changes the focus to be on the final quality of the product. To achieve this... Download above file for full tables and figures, or for overview, see HTML Version. |
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Selecting Particle Counters for ISO 14644 Certification of Cleanrooms (388.0 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Choosing the Most Suitable Non-viable Particle Counter Sample Point Locations (173.8 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Wireless Particle Monitoring of Cleanrooms (1.0 MB) This article explains how wireless technology can improve the way that particles are monitored within pharmaceutical cleanrooms, while meeting validation and calibration requirements. Download above file for full tables and figures, or for overview, see HTML Version. |
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Selecting an Airborne Particle Counter (360.5 KB) As printed in Cleanroom Technology, November 2005. Download above file for full tables and figures, or for overview, see HTML Version. |
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Glossary of Common Terms used in Particle Counting (612.1 KB) This paper defines the most common terminology used in particle counting, including "Differential Counts," "Counting Efficiency," ... Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Monitoring in Sterilizing Tunnels (579.1 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Testing Techniques for Verifying Medical Device Component's Cleanliness (724.8 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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FDA Paper Review on 21 CFR Part 11 (580.3 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Monitoring Requirements for Freeze-Dryed / Lypholized Pharmaceutical Products (602.5 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Counters for 5.0 micron Airborne Particles (582.2 KB) This paper discusses flow rate and tubing issues that need to be considered when sampling 5.0 micron particles. Download above file for full tables and figures, or for overview, see HTML Version. |
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New Hydrogen Peroxide Analyzer, 2007 (125.9 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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VHP Frequently Asked Questions and its Effect on Particle Counters (28.2 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Airnet® 510 XR Particle Counter Resilience to Vaporized Hydrogen Peroxide (631.9 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
WEBCAST: The Plain Truth About USP 797This webcast can be attended live on January 30, 2007, or can be viewed on demand until Jan 30, 2008. |
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