ABOUT PARTICLE MEASURING SYSTEMS

Providing you with the superior knowledge, technology, quality, and service you need to successfully Meet Regulatory Requirements and manufacture your product. Particle Measuring Systems partners with industry companies as a complete contamination monitoring solutions provider. Starting with our Advisory Services team, then collecting data with our viable and non viable particle counters, thru to complete data management and reporting. We have the expertise to help you meet regulatory requirements and get your product to market.  As one of the world’s leading clean room contamination control experts and complete solutions provider, we offer fully integrated and robust monitoring solutions including:

  • Particle Counters and Microbial Samplers, remote and portable
  • Environmental and Facility Monitoring Systems
  • Data collection and Data Management (DM)

Additionally, we offer a wide variety of expert advisory services including:

  • Sampling locations
  • Risk Assessments – avoiding 483s
  • Thermal Validations
  • Crisis Handling – 483 management and response

As a trusted thought-leader in the pharmaceutical cleanroom and other life science industries, our team provides multiple webinars, papers, and training throughout the year to support professionals and clean room manufacturers through the necessary regulatory processes.

FEATURED PRODUCTS

A simple and cost-effective way to monitor your cleanroom, the Airnet II Air Particle Sensor provides unparalleled performance with data transmission capabilities for remote monitoring.

The top Data Collection and leading Data Management companies combined to create a complete contamination monitoring solution for pharmaceutical manufacturers.

Viable, Non Viable and Environmental Monitoring Software.

FacilityPro® Cleanroom Software by Particle Measuring Systems provides the interface, data management, and reporting for an environmental monitoring system. FacilityPro’s ability to manage viablenonviable, and environmental data through a common system improves the efficiency of production operations and quality investigations.

Facility Monitoring System with industrial control systems assures data integrity, process automation, simplicity of use, and data integration.

A compact, user-friendly variable channel remote particle counter. Designed for minimum downtime and multiple option flexibility.

Innovative new portable particle counter meeting all regulatory requirements.

Monitor your viable and non-viable particles according to the most recent regulatory requirements. Count, report, document and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements.

Particle Measuring Systems partners with companies in the Pharmaceutical industry as a complete contamination monitoring solutions provider. Starting with our Advisory Services team, then collecting data with our viable and non-viable, particle counters, through to complete validation, data management and reporting. We have the expertise to help you meet regulatory requirements including ISO 14644-1:2015 and EU GMP Annex 1 to get your product to market.

The Lasair® III Aerosol Mobile Particle Counter minimizes operator errors with intuitive recipe configuration and meets ISO 14644-1/2:2015, ISO 21501-4, EU-GMP.

The MiniCapt® Remote Air Sampler features modern, easy to use data and sample configuration management by integration with a FacilityPro® system.

The BioCapt® Microbial Impactor meets regulatory requirements - remote sampling and ISO 14698-1/2 compliance.

The Airnet® II Particle Sensor is part of an automated monitoring system reducing manpower that provides consistent location monitoring.

The BioCapt® Single-Use Impactor secures the process, product, and ultimately the patient by avoiding contamination risks.

The APSS-2000 Liquid Particle Counter for USP 788 sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards. When it comes to particle monitoring quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.

A compact, VHP resistant remote particle counter.
As part of a facility monitoring solution, the IsoAir® Pro-E Remote Particle Counter from Particle Measuring Systems (PMS) is an effective piece of a Contamination Control Strategy using the latest technologies to streamline cleanroom monitoring while meeting global regulations including EU GMP Annex 1, ISO 14644-2, and part of a 21CFR Part 11 solution. This remote particle counter has all the features you need for reliable particle monitoring in your clean area are built into a simple but powerful package.

 

The Lasair® III 110 Airborne Particle Counter is a laser diode-based true 0.1 micron (μm) particle counter with 1.00 CFM flow rate. It provides real-time measurement of yield-impacting particles with three configurations to meet your unique application needs. Part of the series of cleanroom particle counters from Particle Measuring Systems.

The MiniCapt® Mobile Microbial Air Sampler from Particle Measuring Systems (PMS) is an innovative, light and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.

CONTACT INFORMATION

Particle Measuring Systems

5475 Airport Blvd.

Boulder, CO 80301

UNITED STATES

Phone: 303-443-7100

Contact: Nina Morton

FEATURED ARTICLES

  • A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more. 

  • In our recent webinar many thoughtful questions were asked that concern how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Here we answer questions submitted after the webinar regarding active air and settle plates, rapid micro methods, and specific applications.

  • Industry standards require that injectable solutions are effectively monitored for microcontamination, specifically nonsoluble particulates. In this paper we review counting particle specifications based on the type of injectable solution as well as the apparatus and methodologies you can use to demonstrate compliance.

  • Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess overall environmental control performance.

  • This paper covers many of the new EU GMP Annex 1 topics including system design, monitoring, cleaning and disinfection, risk assessment, microflora, events and deviations.

  • Here we review the description of current good manufacturing practices (cGMPs) and how they can be applied to a continuous monitoring system installed within a facility.

  • When considering where to place sample points for particle monitoring, whether it will be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.), the answer is not always straightforward. Here, we help to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.

  • Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry, otherwise known as Industry 4.0. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.

  • When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination. The best way to locate sources of contamination is via risk assessment, best performed before a process has been implemented. There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.

  • Environmental Monitoring (EM), particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.

  • Contamination control strategies (CCS) are designed to prevent and control potential contamination from reaching the point of no return: the product. Once contamination occurs, there is no cost-effective removal scheme to continue production, making the determination of sources all the more important. Learn how to create an effective CCS.

  • Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively.

  • The USP 797 requires sterility of all Compounded Sterile Products (CSP). Environmental Monitoring is an essential component to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. Learn more about what viable and nonviable monitoring involves.

  • The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

  • The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The latest Annex 1 draft has some new definitions and guidance regarding cleanroom classification, qualification, and monitoring.

  • This short application note provides a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.

  • Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.

  • Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.

  • A basic understanding of particles and particle counting to help improve your cleanliness levels. In this beginner's guide to particle technology, you will learn about the physical nature, origins and behavior of particles.

WEBINARS

  • The journey of a novel bioconjugate into clinic is complex and uncertain. In this webinar, we explore the particular challenges when moving a bioconjugate candidate from early development into clinic. Our experts will share key considerations for de-risking this journey. From navigating the diverse conjugation technology landscape to designing a robust and scalable process through development. Several customer case studies will illustrate how Lonza’s expertise and integrated solutions have helped drug developers to bring their innovative therapeutics to life.

  • To accelerate the delivery of life-saving therapeutics, it is essential to evaluate ways to maximize efficiencies, while minimizing risk, to stay up to speed with the growing demand. Learn more about accelerating mAb drug development to meet increase in recent mAb FDA approvals.

  • In this webinar you will learn how to choose the best filter plate for your specific applications and understand pore size, membrane material, well volumes and tip types.

  • Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient and hybrid services utilizing a global GMP depot network.

  • Explore the underpinning mechanisms driving freeze thaw applications and their implications across varied drug product containment configurations and volumes,

  • A case study in how Pall Corporation and Lonza successfully worked together to create an effective training program.

  • As more products are moved into single use fermenters, there is greater need to improved oxygen delivery closer to or beyond the abilities of stainless-steel vessels.

  • This webinar discusses how intestine-on-a chip technology reliably models gastrointestinal disease and assists researchers in screening for safe, effective therapeutic candidates. 

  • For reagents, security of supply is a regulatory requirement, a factor that’s critical to consistently monitoring host cell protein (HCP) during the production of a biologic.

  • Learn how leading biopharma companies such as Sanofi and single-use solutions provider Thermo Fisher Scientific are addressing supply challenges and developing collaborative processes. 

  • Explore the challenges imposed by deep cold storage conditions and outcomes on functional performance, sub-visible particles performance, and container closure integrity related to prefillable syringes.

  • Today’s top life sciences manufacturers are dramatically reducing deviations with real-time intelligence. Going digital gives you the power to track and control deviations. Our webinar will show you how.

  • Today’s Life Sciences companies are facing major challenges to their continued operations and profitability as they deal with a changing workplace. Add in the existing challenges of patent expirations, low R&D productivity, increased competition, decreasing margins and non-optimized processes, and the result is uncompetitive cycle times along with unprecedented cost and compliance pressure.

  • The recent pandemic revealed that with the proper framework, a drug product can be developed, clinically tested, and produced for hundreds of millions of patients in less than a year. 

  • Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights.

  • In this webinar, a panel of experts articulate a realistic and achievable vision for QC labs that will help increase productivity for timely batch release while improving data integrity and regulatory compliance.

  • The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects.

  • Speeding innovative and successful new drugs to patients will require the end-to-end, digital transformation of CMC processes. Explore how “always-on,” digital lab informatics services can improve collaborative innovation and productivity across your global CMC organization.

  • Potency assays are an important part of the drug development process and are required throughout the lifetime of the product. Explore the process of assay development, qualification, and validation for critical potency assays and how Sartorius supports customers through this vital step.

  • Featured speakers discuss the effect of excipient choice on the process of manufacturing topical products, including surface active agents, preservatives, polymer choice and skin penetration enhancers.

  • Sometimes we focus on data while forgetting how poor practices, bad decisions, incorrect definitions, and lack of evaluations effect the outcome. In this webinar, we analyze how to go from “data” to “data quality” to improve your overall contamination control strategy.

  • Settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.

  • Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy.

  • Join iBio COO Randy Maddux, Kyowa Kirin EVP Paul Testa, and Sutro Biopharma VP Devendra Luhar for a spirited discussion on aversions to and advantages of biopharma manufacturing automation.

  • Antibodies play a critical role in research, diagnostics and therapeutics. Recombinant antibodies offer a wide range of quality attributes, with one key advantage being their amenability to sequence-based editing to meet specific research goals. Learn about the latest developments in recombinant antibody technology including a platform where recombinant antibodies can be rapidly engineered into diverse formats and novel molecules such as immunocytokines or bispecific antibodies.

  • If intensified processes lead to productivity improvements, then the Cell Line Development Toolbox holds the answers to make intensified bioprocessing a reality. Learn more about these technologies to optimize clone selection, shorten seed trains, and speed up early process development.

  • Scott Merz, Business Development Manager at Asahi Kasei Bioprocess America, provides his take on oligonucleotide manufacturing market growth, keys for development, and scale-up challenges.

  • Scaling gene therapy, mAb, or vaccine therapeutic drug products from bench to manufacturing involves a balancing act between project management, risk mitigation, and process parameter selection. In this webinar we explore the ways to apply best practices through implementation of the Biotech Integrated Solutions service architecture for large-scale manufacturing projects, ultimately accelerating speed to market.

  • Laboratory testing can be a bottleneck. Scientists must wait for the characterization of a new active ingredient. Manufacturing needs the recipe and appropriate test methods to produce a new drug and the results to release a final product. Disconnected processes and data silos hinder data capture, process execution and documentation. Tedious and time-consuming laboratory operations make it difficult to respond quickly to your organization’s needs. Connecting data, people and processes in a unified laboratory informatics environment helps to streamline and standardize laboratory workflows, while also improving regulatory compliance and lab productivity. By removing the bottlenecks from your laboratory, you can accelerate vital therapeutics to your patients.

  • Developing an effective drug-device combination product for self-administered biologics is a complex process. A well-executed strategy will help support integration with manufacturing operations and successful drug delivery.

  • Developing an effective drug-device combination product for self-administered biologics is a complex process. A well-executed strategy will help support integration with manufacturing operations and successful drug delivery.

  • The development and manufacturing of biologics is highly complex, difficult and costly, because biomolecular processes rely on a variety of dynamic interactions. Often, the specifics of these interactions are difficult to capture via physical experimentation alone. Investigating and testing hypotheses in silico, prior to costly and time-consuming experimentation, can help scientists to elucidate the energetics of processes, providing insight into their mechanism of action and properties. In silico techniques can help scientists to characterize and improve candidate performance for biologics lead identification and optimization. Simulation can accelerate the development of biologics and reduce the time and expense involved in bringing these therapeutics to patients.

  • Learn how swallowability and palatability play key factors related to patient acceptability and product development and about the variety of taste masking strategies including excipients, organoleptic and barrier coating approaches, and microencapsulation technologies.

  • Natural killer (NK) cell therapy is a rapid emerging field with several advantages over chimeric antigen receptor (CAR) T-cells for cancer treatment. Like any biotherapeutic drug, cell-based therapeutics must also undergo tight scrutiny for their critical quality attributes (CQAs). There are different criteria evaluated for drug purity, with the presence of visible and sub-visible particulate matter being one of them. Particulate impurities can affect drug efficacy and stability but can cause undesirable immunogenicity and toxicity when injected. In this webinar, we will showcase Micro-Flow Imaging (MFI) as a sub-visible particle analysis solution to differentiate NK cells and its expansion components with either irradiated K-562 feeder cells or Cloudz™ microspheres.

  • Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.

  • This webinar covers a well-designed single-use flexible enclosure system that delivers equivalent if not better containment performance than a hard-shell isolator, at a fraction of the cost.

  • Dr. Julie Wei discusses AAV empty and full separation using the icIEF method, showcasing how icIEF separates an AAV drug substance that could not be separated using other techniques.

  • Discover the Vitaldose® EVA platform for creating injectable and implantable long-acting drug delivery products. Learn the technology's technical basics and how it can be used to deliver small molecules, peptides, and biologics, including some predictive modeling of the release of drugs from EVA.

  • Single-use downstream applications including, chromatography, filtration, and purification create difficult environments for supplier components due to the presence of chemicals across a wide pH range. Aseptic connectors are crucial components to these processes to maintain efficiency and sterility. For this reason, CPC is introducing a connector utilizing chemically stable and robust materials.

  • Today’s Life Science companies face major challenges to continued operations and profitability including patent expirations, low R&D productivity, increased competition, decreased margins, non-optimized processes and mounting compliance pressure. In addition, shifting and changing workplaces in the Age of COVID are challenging companies with unprecedented cost pressures and uncompetitive cycle times.

  • Introduction and general cleaning concepts including detergent selections and chemistry in Life Sciences, COVID-19, Cannabis Cleaning, RNA and DNA cleaning, and more.

  • Cryo electron microscopy (cryo-EM) can help you determine structures for challenging proteins like membrane proteins and larger complexes. Check out our presentation for tips on purifying your cryo-EM samples.

  • This webinar reviews how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

  • Today, most of the COVID-19 vaccine containers are vials, thanks to their flexibility in the drug development phase and their possibility of delivering multi-doses with a single container. Due to the several benefits, such as reducing medical dosing errors, minimizing the risk of contamination by the ease of use, and reducing waste of drug products, syringes will represent a win-win scenario for end-users and manufacturers.

  • Watch this webinar to discover how technology for searching, machine learning, predictive and prescriptive analytics, and modeling and simulation can help lab operations to leverage scientific data end-to-end to make knowledge-driven decisions in real time to ultimately speed time to market. Key topics covered: How to unlock the potential of your existing lab data; How predictive and prescriptive analytics can help scientists become more efficient and effective; Uncover new opportunities for modeling and simulation to save time during both short and long projects.

  • Sartorius expert Priyanka Gupta explains how intensified solutions for upstream and downstream processes can increase productivity by 4X and reduce upfront investment by 50%.

  • Watch this webinar to learn how increasing market and regulatory demands for safety and efficacy are driving pharmaceutical R&D to improve upstream discovery efforts. Discover how AI and machine learning technologies are gaining popularity in extracting knowledge from a multitude of resources and enabling precision medicine.

  • Sartorius expert Gerben Zijlstra walks through a product lifecycle, focusing on upstream process intensification and the criticality of analytical tech and perfusion-based tools.

  • There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field to accelerate life-saving therapies from the bench to the bedside.

  • Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.