Videos

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.

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.

Observe the innovative and unique design for the microbial air sampler, the MiniCapt® Mobile with:

• Flexibility for air and compressed gas viable sampling
• Reduced operator errors from data management and touch screen
• Filtered exhaust eliminates contamination
• Impactor design allows false positive identification
• ISO 14698:2003 compliant

Combine with the BioCapt® Single-Use Microbial Impactor for a fully validated system.

Particle Measuring Systems introduces the New Era of Microbial Sampling.

Find out more about this uniquely designed replacement for settle plates, the BioCapt® Single-Use Cleanroom Microbial Monitor that helps minimize false positives for microbial activity in pharmaceutical cleanrooms reducing contamination from handling of agar settle plates.

Holding an agar plate with isolator gloves can be difficult, even causing drops and spills. Learn how the BioCapt Single Use solves that problem.

Learn more about continuous monitoring or the BioCapt® Single Use Impactor.

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.

Get a quick overview and explanation of the features of the MiniCapt Mobile Active Air Sampler and how you can optionally use it with the BioCapt Single Use Impactor (replacement for settle plates).

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.

Benefits of the Lasair III Portable particle counter battery include:

• Light-weight, high capacity battery
• Li-Ion
• 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

Learn about the currently drafted sections in Annex 1 that deal with viable monitoring requirements and future expectations by watching this brief video.

Learn more about continuous monitoring or the Biocapt Single Use Impactor

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

This short video discusses Using a Risk Assessment strategy to identify microbiological plate incubation conditions and also data interpretation: Applying identified incubation conditions.

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.

The Lasair® III Cleanroom Particle Counter is designed with your unique needs in mind. It sets the standard for portable aerosol particle counters in highly regulated environments. It can be used for both remote and mobile routine cleanroom monitoring. Watch this short video to learn more.

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.

This video quotes all the sections in the newest Annex 1 draft that apply to cleaning and disinfection and provides guidelines and practical interpretations.

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

Find out more about our Advisory Services Team or visit our Quality Risk Management blog.

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.

As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software.

Learn more about FacilityPro® Monitoring System.

Particle Measuring Systems provides a central hub for an environmental monitoring system.

Find out more about FacilityPro® Cleanroom Software for Pharmaceuticals or learn about the FacilityPro upgrade.

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.

Learn more about Data Trending Requirements, Data Integrity Regulations, and PharmaIntegrity™ Data Management System for the Pharmaceutical industry.

The APSS-2000 Liquid Particle Counter for USP 788 is a fully contained syringe sampling liquid particle counting system. It provides user flexibility from the many liquid sampling configurations to the comprehensive Sampler Sight software that allows the user to collect, analyze and report data from one simple platform. The software is validatable and 21CFR11 compliant. Learn more from this expert demonstration. Learn more about our APSS 2000.

Particle Measuring Systems introduces the New Era of Microbial Sampling.

Find out more about this uniquely designed replacement for settle plates, the BioCapt® Single-Use Cleanroom Microbial Monitor that helps minimize false positives for microbial activity in pharmaceutical cleanrooms reducing contamination from handling of agar settle plates.

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.

Our expert Contamination Control Advisors are available to assist you.

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 Annex 1 draft addresses the gaps with data analysis and trends.

Quick overview of environmental monitoring cleanroom software upgrades for the Pharmaceutical / life sciences industries.

Learn about FacilityPro® Cleanroom Software for effective data management.

Particle Measuring Systems provides a central hub for an environmental monitoring system.

Find out more about FacilityPro® Cleanroom Software for Pharmaceuticals or learn about the FacilityPro upgrade.

As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software.

Learn more about FacilityPro® Monitoring System.

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.

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.

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.

You will learn and understand more about:

• Why we should count particles in injectable drugs
• What regulatory requirements are for USP 788-789-729
• Light obsuration technology that’s required
• How to ensure instrument performance and accuracy are to perform (USP 1788 suggested tests)
• See demonstration of APSS 2000 Particle Counter

Useful resources can be found in our Knowledge Center or learn more about 21 CFR11 and Data Integrity Regulations.