Learn more about contamination control, cleanroom monitoring, particle counting, regulatory requirements, particle counting applications and more… view Particle Measuring Systems’ educational and product videos.
Particle Measuring Systems, the complete environmental monitoring solution provider.
Since 1972, Particle Measuring Systems has been the global expert in contamination monitoring, providing the pharmaceutical and other life science industries with the expertise to detect, analyze and manage cleanroom contamination so you can meet all regulatory requirements including ISO 14644-1:2015 and EU GMP Annex 1.
Partners for Total Contamination Control Solutions
When looking for a contamination control strategy for your aseptic processes, consider a partner who has the expertise to answer your questions, support your project from start to finish, and then provide you with reliable and professional ongoing support.
In this brief video, Daniele Pandolfi of Particle Measuring Systems highlights the importance of this and discusses considerations when choosing a partner.
Particle Measuring Systems has a global team of experts to provide you with complete cleanroom contamination monitoring solutions and data management wherever you are in the world.
APR Big Data Documentary
This big data documentary was originally published in conjunction with American Pharmaceutical Review. It covers both the data compliance requirements for the Pharmaceutical industry and how to leverage the mass quantities of data that are now available to enhance pharmaceutical products, and ultimately, patients lives.
Data Trending-Alert/Action Level Settings EU GMP Annex 1, Rev. 12 Draft
In this brief video, Daniele Pandolfi discusses the Annex 1 draft and some of the aspects that can be used to understand the current state of regulatory positioning. It covers Trending Relevance (current Annex 1 vs Rev 12 Draft), Environmental Trends (approaches and procedures), and Level Settings (definition and process). The new draft addresses the gaps with data analysis and trends.
Accessing, reporting, and approving on cleanroom data remotely (working from home)
In the new working environment it is more important than ever to be able to access data from office locations while working remote. Go paperless in a 21CFR11 environment using Particle Measuring Systems’ PharmaIntegrity. Watch the video below and then learn more about a solutions at https://lnkd.in/dEGVYf7
FacilityPro® Environmental Monitoring System
As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software.
FacilityPro Software Updates for Pharmaceutical Net Pro and Smart
Quick overview of environmental monitoring cleanroom software upgrades for the Pharmaceutical / life sciences industries.
Cleaning and Disinfection Guidelines; EU GMP Annex 1, rev 12 2020
This video quotes all the sections in the newest Annex 1 draft that apply to cleaning and disinfection and provides guidelines and practical interpretations.
Annex 1 rev 12: Using a Risk Assessment to set microbiological plate incubation conditions
This short video discusses Using a risk assessment to identify microbiological plate incubation conditions and also data interpretation: Applying identified incubation conditions. .
Science v. Standardization: Meeting auditor’s expectations by understanding the reasoning behind the rules
Annex 1 requires designing an effective contamination control strategy based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 frequently uses the terms “risk” “justify” and “strategy”, underlying the importance of these concepts.
Paola Lazzeri discusses relevant Annex 1 areas (4.1, 4.32, 9.6, 9.21, 9.24, 9.29, 9.33, 9.38, 9.45), providing insights and highlighting important considerations when creating a contamination control strategy.
Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12
An industry expert explains the latest guidelines from Annex 1 around Cleanroom Classification, Qualification, and Monitoring. Starting with defining each of these items, through the latest changes, Maurizio Della Pietra guides the viewers through items to consider including identifying sampling points, the need for a risk assessment, and the latest microbial requirements.
Annex 1 2020 Alternative Micro Methods and Rapid microbial
This video covers the 2020.03 (rev 12) sections of Annex 1 related to Alternative micro methods and rapid microbial. The presenter is Frank Panofen, PhD, of Particle Measuring Systems.
Single Use Guidelines according to EU GMP Annex 1, rev 12 2020
Learn about the latest guidelines for single use systems according to the latest Annex 1 guidelines. Paola Lazzeri also discusses how the BioCapt Single Use microbial impactor meets those requirements.
Quality Risk Management and Annex 1, rev 12 draft
This video highlights the requirements related to Quality Risk Management that are specifically mentioned in Annex 1, specifically:
- PQS- Manufacture of sterile products
- Utilities Monitoring
- V/NV Environmental and Process Monitoring
MiniCapt® Mobile Microbial Air Sampler
MiniCapt Mobile Active Air sampler: the flexible solution for microbial air sampling
The MiniCapt mobile active air sampler has a wide variety of accessories available to make it usable throughout your production process and throughout your facility. There is a gas sampling kit, accessories for isolators, the stainless steel head for use on your filling line, and also a single use impactor. Learn more by watching this short video.
Particle Measuring Systems provides a central hub for an environmental monitoring system.
Lasair® III 5100 Aerosol Particle Counter
How to create recipes for the Lasair III portable particle counter.
This quick tutorial video walks you through the steps to easily create recipes for the Lasair III portable particle counter.
This quick tutorial video walks you through the steps to easily create recipes for the Lasair III portable particle counter. The Lasair® III Portable Particle Counter sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and ISO 21501-4. It is designed for cleanrooms with your unique needs in mind.
Lasair III Portable Particle Counter Li-Ion Battery Details
Benefits of the Lasair III Portable particle counter battery include:
- Light-weight, high capacity battery
- Hot swappable for extended use
- 3-5 hours of operational time on a single charge depending on unit
- Robust battery design with excellent capacity through hundreds of charge cycles
- Available stand alone charger for increased portable operation time
Lasair III Infrared Touch Screen details
Learn about the Lasair III particle counter touchscreen size & technology.
The Lasair III uses infrared technology, using a matrix of sensors to ensure fast response and the ability to interact with gloves, stylus, etc.
Comparisons to other touchscreen technologies (resistive and capacitive) are also discussed.
Learn why the infrared touchscreen is ideal for cleanroom applications.
USP 788 and APSS 2000 demo
BioCapt® Single-Use Microbial Impactor
Particle Measuring Systems introduces the New Era of Microbial Sampling.
Data Integrity support by the BioCapt Single Use Microbial Impactor
Learn how BCSU can be an effective and important part of your data integrity program by watching this short video. Learn more about BCSU for your cleanroom microbial monitoring.
Microbiological Plate Incubation per Annex 1 draft, Rev 12
In this brief video, Teresa Riccioni discusses the application of a risk assessment to set appropriate microbiological plate conditions per the new EU GMP Annex 1 draft, Rev 12. It starts with the new Annex 1 draft requirements to use a risk assessment, and then an interpretation on how to apply it and use it in different stages of the manufacturing process.
Pinpointing a Particle Source
The HandiLaz Mini II handheld Airborne Particle Counter is ideal for users who are in need of convenient cleanroom monitoring and serves as a diagnostic tool to troubleshoot sources of particle generation without the hassle of heavy equipment
Quickly Verify a Cleanroom with the HandiLaz® Mini II
See how to quickly verify the cleanliness of a cleanroom using the portable, handheld, easy to use HandiLaz Mini II.
Surfex® Testing Station
Know whether or not your parts are truly clean.
Learn how the Surfex® Testing Station works quickly and accurately with repeatable results to make sure your parts are truly clean.