Most Recent

Ensuring a Successful Audit: Effective Risk Assessment Design

When related to Environmental Monitoring (EM), risk management often refers to a complete understanding of
how often and how severe a process can be affected by external factors. The development of this knowledge, a
risk assessment, is the culmination of multiple party's efforts, including Quality Engineers, Microbiologists, and
Production staff. Actions involved in completing a risk assessment start at the very beginning of new cleanroom
construction with the identification of product impact sources. The relative risk to product quality is given
hierarchy using well-established assessment tools.
In order to prepare for this process, it is important to attain a strong base of EM knowledge.

read all

Common ISO 14644-2:2015 Questions and Answers

The recently updated ISO14644-2:2015 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 providing you with answers to many of the questions that our customers frequently ask.

read all

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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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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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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Surfex: An Essential Incoming Quality Analysis Tool

Particle Measuring Systems' Surfex® is a purpose-built automated parts cleanliness verification system integrating the elements of a leading edge analytical laboratory in a single package. 

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Quality by Design and Single-Use Air Sampling Approaches

Quality by Design (QbD) is a method approach to developing a quality control system using predetermined
objectives. It uses the foundations of risk management and science to ensure a repeatable process to
manufacture high-quality product. In 2002, the FDA launched QbD as part of its innovation initiative. This paper
outlines resources for increasing productivity, decreasing cost and implementing a quantifiable, conclusive and
cost-effective monitoring strategy.

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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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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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Most Popular

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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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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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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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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HCT/P Environmental Monitoring Requirements

The Food and Drug Administration (FDA) requires human cell, tissue, and cellular and tissue-based product establishments to follow the current Good Tissue Practice (GTP)

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Common ISO 14644-2:2015 Questions and Answers

The recently updated ISO14644-2:2015 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 providing you with answers to many of the questions that our customers frequently ask.

read all

Are your particle counters ISO 14644-1 compliant?

Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?

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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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Understanding ISO 21501-4 (EL)

ISO 21501 has the title Determination of particle size distribution—Single particle light interaction methods.

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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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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.

read all

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

Surfex: An Essential Incoming Quality Analysis Tool

Particle Measuring Systems' Surfex® is a purpose-built automated parts cleanliness verification system integrating the elements of a leading edge analytical laboratory in a single package. 

read all

Ensuring a Successful Audit: Effective Risk Assessment Design

When related to Environmental Monitoring (EM), risk management often refers to a complete understanding of
how often and how severe a process can be affected by external factors. The development of this knowledge, a
risk assessment, is the culmination of multiple party's efforts, including Quality Engineers, Microbiologists, and
Production staff. Actions involved in completing a risk assessment start at the very beginning of new cleanroom
construction with the identification of product impact sources. The relative risk to product quality is given
hierarchy using well-established assessment tools.
In order to prepare for this process, it is important to attain a strong base of EM knowledge.

read all

Common ISO 14644-2:2015 Questions and Answers

The recently updated ISO14644-2:2015 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 providing you with answers to many of the questions that our customers frequently ask.

read all

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? There is increasing confusion over the requirements for compliance
with EC GMP Annex 1 limits on 5.0 μm particles, especially when compared with the ISO 14644-1 calculations
recommended for establishing conditions for such testing.

read all

Quality by Design and Single-Use Air Sampling Approaches

Quality by Design (QbD) is a method approach to developing a quality control system using predetermined
objectives. It uses the foundations of risk management and science to ensure a repeatable process to
manufacture high-quality product. In 2002, the FDA launched QbD as part of its innovation initiative. This paper
outlines resources for increasing productivity, decreasing cost and implementing a quantifiable, conclusive and
cost-effective monitoring strategy.

read all

Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring [Webinar Presentation]

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control.

read all

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.

read all

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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