Most Recent

Assuring Data Integrity in an Environmental Monitoring System [Frequently Asked Questions]

This FAQ paper answers questions pertaining to the data management, security and calibration ofThis FAQ paper is a follow up to the webinar, “Assuring Data Integrity in an Environmental Monitoring System”. Many thoughtful questions were asked about current and future trends of data management. Questions submitted during and after the webinar are answered below.

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Controlling Quality in Advanced Optics Manufacturing [Frequently Asked Questions]

This FAQ paper is a follow up to the webinar Controlling Quality in Advanced Optics Manufacturing.
During this webinar there were many good questions about monitoring contamination in clean optics manufacturing environments. Download this paper for answers to all questions. 

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APSS-2000 and SamplerSight Pharma [Frequently Asked Questions]

This FAQ paper answers questions pertaining to the data management, security and calibration of
systems employing APSS-2000 and SamplerSight Pharma.

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Particle Data Collection and Interpretation for ISO Cleanrooms

Facility Monitoring Systems (FMS) (or Environmental Monitoring Systems – EMS, as they are sometimes referred to) gather data from a variety of sensors, including particle, microbial or environmental. Once all the data is gathered it must be correctly interpreted to be useful and effective. This paper addresses how to set up the FMS collection settings to support effective interpretation of the particle data to ensure effective cleanroom monitoring and particle management.

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Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological

The last decade brought an impressive list of technological advances, ensuring the sterility and quality of a myriad of new drug and biological products, in addition to medical devices. These advances bring new treatments, improve quality of life and extend life expectancy for millions of patients. This paper summarizes some of those new technologies and focuses on a few examples ...

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Mobile Monitoring System Speeds Detection, Localization and Troubleshooting of Molecular Contamination Sources

Decreasing the time to detect, contain and mitigate very low levels of Airborne Molecular Contamination (AMC) is becoming more critical for high tech manufacturers,

 

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Data Management Series 4 - FacilityPro® Automation Solutions Versus a PC-based System for Environmental Monitoring

The current trend in Environmental Monitoring systems is to offer a more industrial automated solution versus the older PC-based approaches. The PC-based Environmental Monitoring System was common in the late 1990 and early 2000s.

 

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A New Rapid Microbiology Method based on Measuring Oxygen Depletion

In this paper we describe an oxygen, depletion-based method as a rapid microbiology assay to test surface microbial contamination in cleanroom environments.

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Most Popular

ISO 14644-1:2015 Revisions Summary

The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

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Paper Series: Guides to Particle Technology

This three part paper series teaches you about particles and particle control in a cleanroom environment. Download this first paper now to get started...

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ISO 14644-1:2015 Frequently Asked Questions (FAQs)

The newly updated ISO14644-1:2015 has caused some confusion and raised concerns by companies who want to ensure that they are fully compliant. To address these issues, Particle Measuring Systems is sharing our industry expertise and have provided an ISO 14644-1:2015 summary paper, an on-demand webinar, and are now providing you with answers to many of the questions that our customers frequently ask.

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Understanding ISO 21501-4 (LS)

Cleanrooms that manufacture products adopt procedures to improve yield and increase throughput

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USP <1116> and its Implications for Measuring Microbial Recovery Rates

The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbial Control and Monitoring of Aseptic Processing Environments Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (CFU).

 

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USP 797 Summary and Solutions

This easy to read paper summarizes and highlights ISO 14644 and USP 797 definitions and requirements and then continues on to demonstrate how you can meet USP 797 requirements to be compliant. 

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Overview of USP 1223 and EP 5.1.6- Validation of Alternative Microbiological Methods

These documents provide guidance on the selection and implementation of assay methodologies to serve as alternatives to compendial microbiological methods.

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All Knowledge / Papers

Particle Loss in Transport Tubing

Multiplexing air samples from various sample points into a single particle counter, such as a Lasair® III, offers the ability to monitor small particle sizes at a reasonable cost.

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APSS-2000 and SamplerSight Pharma [Frequently Asked Questions]

This FAQ paper answers questions pertaining to the data management, security and calibration of
systems employing APSS-2000 and SamplerSight Pharma.

read all

Assuring Data Integrity in an Environmental Monitoring System [Frequently Asked Questions]

This FAQ paper answers questions pertaining to the data management, security and calibration ofThis FAQ paper is a follow up to the webinar, “Assuring Data Integrity in an Environmental Monitoring System”. Many thoughtful questions were asked about current and future trends of data management. Questions submitted during and after the webinar are answered below.

read all

Airnet® IIs 2 Channel Particle Sensor

The Airnet IIs particle sensor makes it easy and cost-effective to monitor your cleanroom.

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Controlling Quality in Advanced Optics Manufacturing [Frequently Asked Questions]

This FAQ paper is a follow up to the webinar Controlling Quality in Advanced Optics Manufacturing.
During this webinar there were many good questions about monitoring contamination in clean optics manufacturing environments. Download this paper for answers to all questions. 

read all

Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological

The last decade brought an impressive list of technological advances, ensuring the sterility and quality of a myriad of new drug and biological products, in addition to medical devices. These advances bring new treatments, improve quality of life and extend life expectancy for millions of patients. This paper summarizes some of those new technologies and focuses on a few examples ...

read all

Particle Data Collection and Interpretation for ISO Cleanrooms

Facility Monitoring Systems (FMS) (or Environmental Monitoring Systems – EMS, as they are sometimes referred to) gather data from a variety of sensors, including particle, microbial or environmental. Once all the data is gathered it must be correctly interpreted to be useful and effective. This paper addresses how to set up the FMS collection settings to support effective interpretation of the particle data to ensure effective cleanroom monitoring and particle management.

read all

ISO 14644-1:2015 Frequently Asked Questions (FAQs)

The newly updated ISO14644-1:2015 has caused some confusion and raised concerns by companies who want to ensure that they are fully compliant. To address these issues, Particle Measuring Systems is sharing our industry expertise and have provided an ISO 14644-1:2015 summary paper, an on-demand webinar, and are now providing you with answers to many of the questions that our customers frequently ask.

read all

AM ll - 16/32 Aerosol Manifold for Air Particle Counters

The AM II manifold offers advanced features for sequentially monitoring aerosol contamination at multiple locations with a fixed particle counter.

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