[change country]Pharmaceutical Particle Counting Papers
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Click here to signup and download files (Powder Filling - When and Where to Monitor) Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards. Download this paper to learn more. |
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Click here to signup and download files (Basic Guide to Particle Counters and Particle Counting) 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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Click here to signup and download files (Particle Transportation) Transportation of particles through tubing between the sample inlet and the optics of a particle counter has often been at the forefront of discussion regarding the truth of readings. With the release of the 2009 EC GMP Annex 1 the issue of particle loss of large particles has been elevated such that a better understanding and measurement of those losses is warranted. When the validation implications of losses due to various forces are reviewed, the absolute certainty of a result is always in question. So what are these forces? What are the losses? What are acceptable results? The goal of this paper is to address several of these issues and provide a better understanding of the problem. Download this paper to learn more. |
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Click here to signup and download files (Airnet 510 XR Resilience to Vaporized Hydrogen Peroxide) For pharmaceutical manufacturing, Particle Measuring Systems has addressed the issue of using Vaporized Hydrogen Peroxide (VHP) to clean the Airnet-510 XR particle sensor between batches by coating all critical components with a stable PFA Teflon® layer. Read this paper to learn more. Download above file for full tables and figures, or for overview, see HTML Version. |
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This paper is a review of the PIC/S GMP Annex 1 Interpretation Document, PI 032-2 |
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Click here to signup and download files (Understanding ISO 21501-4) The ISO 21501 standard widens the scope of analysis to include methodology for airborne particle counting and liquid particle counting (both light scattering and extinction methods). Specifically, ISO 21501-4 provides a calibration procedure and verification method for airborne particle counters to ... Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (Technical Review: European GMP Annex 1 - 2008 Edition) 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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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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Click here to signup and download files (EU GMP 5 µm Particle Counter Limits Advice) 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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This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to certify a cleanroom. Special examples of a sterilizing tunnel and lyophilizer are included. Learn more now... Download above file for full tables and figures, or for overview, see HTML Version. |
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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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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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Click here to signup and download files (Quick Steps to Meet USP 797 Compliance) The current USP 797 requirements for particle monitoring can be summarized as to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. (Download paper to learn more) Download above file for full tables and figures, or for overview, see HTML Version. |
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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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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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Click here to signup and download files (Facility Sight 21 CFR Part 11 Compliance) 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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Click here to signup and download files (USP 797 Particle Monitoring) Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (How Many Particles, How Much Sample Volume?) 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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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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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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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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Click here to signup and download files (Wireless Particle Monitoring of Cleanrooms) 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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Click here to signup and download files (Selecting an Airborne Particle Counter) 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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Click here to signup and download files (Glossary of Common Terms used in Particle Counting) 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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Click here to signup and download files (Particle Monitoring in Sterilizing Tunnels) Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (Parts Cleanliness Testing for the Medical Device Industry) Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (FDA Paper Review on 21 CFR Part 11) 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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Click here to signup and download files (Particle Counters for 5.0 micron Airborne Particles) 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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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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