Most Recent

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

This FAQ paper is a follow up to the webinar, “Assuring Data Integrity in an Environmental Monitoring System” and answers questions about data management, security and calibration of an EMS . 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)) 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 Tests

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 sterilitiy assurance 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 Facility Monitoring Systems

The current trend in Facility 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 rapid microbiology method to test surface microbial contamination in cleanroom environments.

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Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the evaluation of the newly released ISO 14644-2:2015.

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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

The first in a three part series, this guide covers the basic details and concepts around monitoring and controlling particle contamination

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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

Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions

Compressed gases are broadly used in medicinal production facilities. A variety of different gases can be introduced into the process at various stages of a product’s manufacture for different reasons. Compressed gases such as air, nitrogen, and carbon dioxide are regularly used in cleanrooms and are frequently employed in purging or overlaying. The cleanliness of compressed gases used during the pharmaceutical manufacturing process is a very important quality factor because in many instances, the gas comes into contact with the medicinal product.

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Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment

The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients, active pharmaceutical ingredient (API) as well as the final drug product (Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product.

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Facility Net

The Facility Net Software provides a comprehensive environmental monitoring solution with real-time and historical

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Best Known Method for Clean Fluid Sampling to Get Consistent Measurements During Offline Particle Analysis

A complete chemical quality monitoring program includes data gathered from the time chemicals are received
all the way to the point of process. Throughout this monitoring program, the best known method (BKM) which
provides optimal data quality and time resolution is continuous in-line monitoring. However, physical and
environmental challenges posed by some chemicals and how they are used can make in-line monitoring
unfeasible. An alternative approach is to use grab samples and offline particle contamination monitoring to
understand...

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Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment

Compressed Gases: A Brief Regulatory Overview

The testing and monitoring of compressed air and other process gases such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products. Compressed air is a Critical Process Parameter (CPP) whose variability has an impact on the Critical Quality Attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

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Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the evaluation of the newly released ISO 14644-2:2015.

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Improve yield and quality by monitoring particle contamination during optics manufacturing

Learn about particle contamination monitoring solutions for the optics industry.

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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.

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