Contamination Monitoring Videos

Giulia Artalli, Micro & Sterility Global Product Line Manager at Particle Measuring Systems, discusses the regulatory importance and benefits of the MiniCapt Mobile product features that were recently released. This industry leading active air microbial sampling product now has antibacterial properties built into the housing to help control the spread of bacterial contamination caused by monitoring activities themselves.

Giulia Artalli, Micro & Sterility Global Product Line Manager for Particle Measuring Systems, discusses the technology and the functionality of the BioCapt Single Use microbial impactor plate as a solution to the single use microbial monitoring requirements in the latest draft of the EU GMP Annex 1.

For small, medium and large clean manufacturing operations, the new Handilaz® Mini II handheld particle counter is a must have in your contamination control toolbox. Paul Dozoretz, Electronics Product Line Manager at Particle Measuring Systems talks about how and why you would use the Handilaz Mini II. With a comprehensive set of features, the HandiLaz Mini II is a low-cost alternative for users who need convenient cleanroom monitoring that also serves as a diagnostic tool to troubleshoot sources of particle generation without the hassle of heavy equipment.

In this interview Daniele Pandolfi talks to Blu Buquoy about about customizable Cleanroom Monitoring Solutions and how Particle Measuring System‘s solutions meet our global customers needs.

“Argonaut Manufacturing Services successfully focuses on its core business. Outside of that we rely on our key partners”, says Eric Blair Argonaut Manufacturing Services Inc. PMS provides the contamination control expertise for safe products and regulatory compliance. In this 2-minute video, Wayne Woodard, Eric Blair, Stacy Sutton, and John Mitchell discuss the value of partnership.

Learn more about Complete Sterility Assurance Products and Services and FacilityPro® Support Services.

Presented by Glen Slayter, Intel and Dan Rodier, Particle Measuring Systems at the 2020 Ultrapure Micro event. Case study on the benefits of and monitoring of particles in ultrapure water (UPW) down to 20 nm. Learn more about the Ultra DI 20 particle counter.

Only Particle Measuring Systems has proven and reliable 20 nm particle counting solutions for water and chemicals.

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.

Learn more about us as an industry contamination monitoring leader or visit our website www.pmeasuring.com.

Learn how a customer used Particle Measuring Systems’ (PMS) Liquilaz particle counter to check the cleanliness of their parts for the semiconductor industry. How clean are your parts?

Learn more about the Liquilaz

When looking for a contamination control solutions provider / partner, consider their level of industry knowledge and the complete support they can provide. Fu-Lun Yu discusses how PMS was able to provide a customer in Taiwan the information they required to be fully prepared for a customer audit.

Particle Measuring Systems has a highly experienced, well-trained team to support your applications. We are direct in every major market.  Learn more or contacts us to support your needs.

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.

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.

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.

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 this video for more solutions.

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.

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

Learn about FacilityPro® Cleanroom Software for effective data management.

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

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

Find more webinars and papers located in our Knowledge Center.

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

 

FMS Implementation

Eric Gottlieb discusses how the Particle Measuring Systems (PMS) plans for a successful facility monitoring system (FMS) implementation and some of the hurdles they have to overcome. Particle Measuring Systems provides complete viable and non-viable particle counters, data management, project implementation, advisory services (Risk Assessment, Sample Location Placement, etc. ) and more to provide our pharmaceutical manufacturing customers with a complete contamination control solution. Learn

After deciding on a cleanroom Facility Monitoring System (FMS) it is time to implement it. Many things can go wrong. You want an implementation that does not negatively impact production, that is smooth and successful, and is ready to hand off on schedule. Eric Gottlieb talks to Blu Buquoy about some of the possible roadblocks and how the team Particle Measuring Systems (PMS) prepares for a successful FMS implementation. Learn more about the PMS turnkey FMS solution.

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.

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.

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.

Learn more about Annex 1 updates and our Advisory Services.  Find other webinars, educational training, and papers in our Knowledge Center.

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.

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.

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).

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.

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.

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.

Interview with Frank Panofen, Marketing Manager at Particle Measuring Systems, as he discusses providing our customers with remote advisory services during the pandemic. Learn how the remote services has not only met face to face expectations, but has exceeded them with value added learnings for our pharmaceutical manufacturers. PMS Advisory Services include risk assessments, review of cleaning and disinfecting strategies, preparing for and reacting to an audit, and more.

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.

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.

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 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.

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.

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.

Learn how BioCapt® Single Use  can be an effective and important part of your data integrity program by watching this short video. Learn more about BioCapt Single Use for your cleanroom microbial monitoring.

In semiconductor manufacturing, because of the ultra small sizes of devices, 20 nm and smaller particles can cause product defects and reduce yields. John Kearns discusses how only Particle Measuring Systems (PMS) has technology proven to detect particles to 20 nm. Learn more about this industry leading particle counter: Chem 20.

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.

Learn more about this and other Annex 1 draft, Rev 12 updates or our Particle Measuring Systems’ Cleanroom Contamination Control Advisory Services.

Remote working, and allowing fewer vendors onsite can make projects very challenging, sometimes pausing projects indefinitely. David Quelle, GM of PMS Brazil, discusses one example where the Particle Measuring Systems‘ team was able to work with a customer to remotely validate their FaciltyPro Environmental monitoring system & MiniCapt Microbial Monitors and conduct training. Watch this short video to learn more about creative solutions from PMS during this unusual time. Contact us to learn how your local team can support you on this

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

See how to quickly verify the cleanliness of a cleanroom using the portable, handheld, easy to use HandiLaz Mini II.

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.

Learn how to set recipes, do a sample, and more with this overview of the portable microbial sampler, the MiniCapt Mobile.

* NEW Antibacterial housing to reduce cross contamination from monitoring activities

* Robust Antibacterial housing and touchscreen design and materials reduce bacterial deposits and biofilm formation more than 95%

* Reduce operator errors with secure data management and easy to use touch screen

* Filtered exhaust eliminates introduction of contamination from unit

* Impactor design allows for false positive identification

* ISO 14698:2003 compliant

Learn how to clean the SLS 1000 using the floss method.

This is the syringe cleaning method which is the first option. For more indepth cleaning see the Floss Cleaning method.