particle monitoring Articles

  • Particle Monitoring in Helmke Drums

    Abstract Now is the time to improve older automated industrial architecture and meet regulatory guidelines with the FacilityPro Environmental Monitoring System. Beneficial impact encompasses QA/QC, production, IT and operator functions, with expansion to microbial collection integration, report and audit trail capability, and the option for system redundancy. The upgrade is a streamlined process ...


    By Particle Measuring Systems

  • Particle Monitoring Requirements in Pharmaceutical Cleanrooms

    All drug products must be manufactured in accordance with the current Good Manufacturing Practice (cGMP) regulations of the country of manufacture or the country/region of export. Pharmaceutical manufacturers must demonstrate compliance with the regulations at every stage before a drug can be released to market. This paper explains the various environmental microcontamination requirements of ...


    By Particle Measuring Systems

  • Wireless Particle Monitoring of Pharmaceutical Cleanrooms

    Introduction Wireless technology has brought many innovative changes, enabling us to communicate in new ways. This article will explain how wireless technology can improve the way that particles are monitored within pharmaceutical cleanrooms, while meeting validation and calibration ...


    By Particle Measuring Systems

  • Uncovering chemical quality improvements through a holistic approach to chemical quality management

    Abstract This paper focuses on a holistic approach to monitoring particles in ultra-pure chemicals from supplier all the way to the wafer surface. As critical dimensions shrink, this understanding will become very critical for cleaning equipment, processes, and the chemical delivery systems that supply them. Advancing technology in particle monitoring capabilities have made it possible to measure ...


    By Particle Measuring Systems

  • Monitoring Precision Parts Cleaning

    Abstract Continued miniaturization of high technology products in a wide range of industries has resulted in the increased need for cleaner parts. Continuous particle monitoring utilizing a wide range of sampling techniques is capable of meeting the challenges and complexity of today’s precision cleaning systems. Particle monitoring of cleaning systems has been shown to increase product ...


    By Particle Measuring Systems

  • Improving paint processes using the temperature-controlled Lasair II 510 particle counter

    Abstract Particle contamination during automotive painting process can cause imperfections in the painting/undercoating causing rework to be necessary. Particle monitoring during this process can reduce the rework volume and provide a predictor of equipment maintenance. An overview of the challenges and a solution for the automotive painting process are ...


    By Particle Measuring Systems

  • Particle monitoring requirements for freeze-dryers

    Introduction Freeze-drying is used to produce the majority of today's dried pharmaceuticals, i.e. those compounds that require reconstitution with water prior to use. Freeze-drying or lyophilization refers to the only manner in which water can be removed from organic substances without damage to the cell structure and subsequent loss of volatile components. The process requires freezing the ...


    By Particle Measuring Systems

  • Advice for EU GMP 5 μm Particle Limits

    Abstract The EU GMP Annex 1 Guide requires continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle counting system, such as the Airnet II or IsoAir 310P. This is because the risk of contamination of finished product is very high and the greatest risk, the operator, is in close proximity. The operator is not only the greatest risk posed to product but also ...


    By Particle Measuring Systems

  • Particle Monitoring in Sterilizing Tunnels

    Portable aerosol particle counters are designed to sample ambient air at 1 cubic foot per minute (1 cfm) and no greater than 35 oC. There are however applications which are based on ambient temperatures much greater than this, such as pharmaceutical sterilizing tunnels. Sterilizing tunnels are used to ensure sterility off glassware (vials, syringes, bottles) prior to their entry onto an aseptic ...


    By Particle Measuring Systems

  • NanoVision Technology Enables Particle Monitoring of High Molecular Scatter Chemistries

    Abstract Semiconductor manufacturing utilizes ultra-pure chemistries which frequently have significant molecular scatter. This high molecular scatter reduces the signal-to-noise efficiency of older particle metrology technology and in some cases prevents its application in more demanding chemistries. In production, an adaptable metrology solution is required to effectively characterize the broad ...


    By Particle Measuring Systems

  • New Particle Monitoring Strategies in UPW for 300 mm Fabs

    Abstract Process failures caused by particles in Ultra Pure Water (UPW) are relatively infrequent events, but with the move to 300 mm wafers and 90 nm line widths, they can have significant financial impact. Most particle monitoring strategies in the past focused on the use of the mobile and inline high sensitivity 0.05 micron particle counters. This paper examines the opportunities to improve ...


    By Particle Measuring Systems

  • Powder Filling – When And Where To Monitor

    Abstract Powder filling is the process predominately associated with active pharmaceutical ingredients (API) where bulk powdered materials are filled into vessels prior to shipping to secondary processors. The very act of powder filling in a Restricted Access Barrier System (RABS) enclosure will create a dust cloud so dense that a particle counter operating in that area will become saturated and ...


    By Particle Measuring Systems

  • Manifold Particle Monitoring: Traditional Limitations

    In traditional manifold systems, a powerful pump pulls air simultaneously from as many as 32 different monitoring locations, with each location as far away as 125 feet. This large cumulative length of tubing, plus the volume of air being moved, requires the pump to create a strong vacuum. As a result, the particle counter samples air from the manifold at a vacuum. The counter no longer draws air ...


    By Particle Measuring Systems

  • OLED N2 Box Monitoring Solutions: Monitoring Solutions

    Welcome back to N2 Box Monitoring Solutions. In this blog, practical approaches to monitoring of N2 boxes and their adjoining systems are discussed. Approach is Dependent on Available Space The best way to avoid secondary contamination from a break in the isolated production box for a particle sample line is to install all particle monitoring system components inside of the N2 box. To be ...


    By Particle Measuring Systems

  • Manifold Particle Monitoring: Improved Accuracy

    The Lasair III Aerosol Particle Counter is the latest generation of aerosol particle counter from Particle Measuring Systems. The Aerosol Manifold II is designed to work with the Lasair III counter under the control of Particle Measuring Systems facility monitoring software (Facility Net). The Lasair III particle counter uses a patented pressure measurement system to avoid the undercounting ...


    By Particle Measuring Systems

  • Planning and Installing an Environmental Monitoring System

    Abstract For aseptic manufacture of pharmaceutical products there has been a shift in procedures for particle measurement, primarily due to legislative regulations. Traditionally, monitoring has been the classic portable monitoring of a cleanroom. New regulations have led to a requirement for an automated, remote monitoring solution. This paper reviews the various steps for the implementation of ...


    By Particle Measuring Systems

  • Microbiological and particle risk assessment of a cleanroom and aseptic filling line

    Abstract A theoretical case study involving the steps of classification, risk assessment and monitoring plan verification was conducted. The classification used total particle concentration and environmental monitoring data and established routine microbiological and particle monitoring points for an aseptic filling line. The cleanroom utilized Grade A, B, C and D zones. After classification, a ...


    By Particle Measuring Systems

  • Trend Analysis of Total and Viable Particle Monitoring Data and Definition of Alert and Action Limits

    Abstract Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess overall environmental control performance. Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. It’s possible to use the limits reported in FDA ...


    By Particle Measuring Systems

  • Real-time statistical process control of aqueous cleaning systems through in-situ monitoring

    Abstract Traditional off-line part cleanliness analysis is too slow for use as a process control tool. These tests, traditionally performed in a laboratory on a small number of representative part samples, are extremely time-consuming. Parts are already integrated into finished product before contamination data are available. Any problems identified at this point require product recall or rework ...


    By Particle Measuring Systems

  • Which Particle Counter is Best for You? Measurement of Ultrapure Water (UPW) and Ultra Clean Fluids

    The purity of water and chemicals used in the semiconductor industry has improved dramatically, creating near particle-free environments. The ITRS roadmap for the future shows continued decreasing line widths and a corresponding decrease in the critical particle size. The increasing cleanliness of liquids and the decreasing critical particle size has caused a corresponding increase in particle ...


    By Particle Measuring Systems

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