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

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

  • As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.). The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the process being monitored. The goal of this article is 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.

  • Past focus was placed on sampling methods for the measurement of potential contamination: particle counters, active air samplers, Petri dishes, and swabs for surface monitoring. This approach has been remodeled to prevent and control potential contamination from reaching the point of no return: the product. This paper outlines defining the CCS and designing the cleanroom that can achieve contamination control.

  • 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

  • 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.

  • 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 the recent oligonucleotide manufacturing market growth, key considerations for development, and common challenges that arise when scaling up equipment.

  • 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.

  • Experts highlight critical issues for clients to ensure successful outcomes for both leading pharmaceutical and biotech drug developers and the global patients they serve.

  • This webinar covers translating the Allowable Daily Exposure (ADE)/ Permitted Daily Exposure (PDE) limits into usage analytical cleaning limits, using the cleaning limits on a day to day basis for multiple equipment trains, ensuring that there is no toxicological significant carry over to the next product and the patient.

  • 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.

  • 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.

  • In this webinar Dr. Julie Wei focuses on Adeno-associated virus (AAV) empty and full separation using the icIEF method and showcases how icIEF separates an AAV drug substance that could not be separated using other techniques and illustrates the icIEF method development.

  • 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.

  • The headspace gas composition in parenteral product containers is critical for sterile oxygen-sensitive drug product. 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. From development to manufacturing and QC, the optimization and control of oxygen levels can play an important role in achieving optimal shelf life and protecting drug efficacy.

  • 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.

  • To meet the demands of next-generation biomanufacturing, the industry will need multiple intensified strategies for upstream and downstream processes. Hear from Sartorius expert Priyanka Gupta as she 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.

  • Biopharmaceutical manufacturers face pressure to increase production within their facilities while also accommodating less-stable molecules not suitable for standard fed-batch platforms. In this webinar, Sartorius expert Gerben Zijlstra walks through a product lifecycle, focusing on upstream process intensification and how PAT and perfusion-based tools are critical components of any solution.

  • 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.

  • Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

  • Amittha Wickrema, Ph.D., Professor of Medicine, Director, Advanced Cellular Therapeutics Facility, University of Chicago, reviews the cold chain workflow from start to finish for a cellular therapy product.

  • If advanced therapies are to be scaled, their management at hospital sites must be scalable. How can we remove complexity — making life easier for couriers, manufacturers, and hospitals — and create a seamless supply chain?

  • During this discussion, panelists examine the cell and gene therapy solutions that have been designed to overcome challenges in the cryogenic cold chain ecosystem.

  • This webinar tackles the key COVID-19-related disruptions affecting manufacturing, data management and R&D in the lab, and how digital technology investments impact drug discovery and marketability.

  • Watch this webinar to learn about emerging mAb purification approaches, strategies for a diversified antibody pipeline, and how process development reduces risk and speeds time to market.

  • Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (CCI) testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This webinar will describe a framework to enable such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.

  • Learn how Maurice can be used to measure surface charge of an LNP-based mRNA vaccine for confirmation of LNP identity in a manufacturing setting, and for stability assessment for process and formulation development. You will also learn how to assess purity, stability and concentration of AAVs.

  • In this webinar, we provide concise technical overviews of relevant platforms and specific examples of the roles automated analytical technologies play in the vaccine development workflow.

  • Pharmaceutical companies must thrive in a challenging business environment defined by regulations, competition, and operational excellence. Learn how advanced analytics can help pharmaceutical and life sciences companies gain insight to important data. This webinar will demonstrate how Seeq enables the integration of myriad data sources for rapid investigation and insight to drive improved decision-making.

  • Improve pharmaceutical technical transfer and accelerate product approval.

  • Dr. Anil Kane, Executive Director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, reviews drug repurposing trends and shares case studies to demonstrate how a CDMO plays a role in drug repurposing and supporting the pharmaceutical industry in taking drugs to market approval.

  • There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.

  • IDBS are announcing the world’s first Biopharma Lifecycle Management (BPLM) system – a cloud-based platform that smooths the bumps of biopharmaceutical development – easing the curation of the data you need to accelerate time to market.

  • In this webinar we are joined by Rahul Chaturvedi, an expert in clinical development with 10+ years of experience, who discusses some of the ways clinical trials are being disrupted and how to shift your mindset to take advantage of this time to strengthen your clinical program.

  • Clinical trials are evolving. Whether it’s disruptive technology, changing regulations, or external factors. The pace of change is only increasing - along with the complexity of ensuring your trial data is secure and compliant. This session will provide best practices and insight into how to keep pace with the changes and be better prepared for what’s still to come.

  • What does pressure to address critical challenges of speed, scale, and supply mean for technologies enabling production, and how does it impact the future of vaccine and biotherapeutic manufacturing?

  • Meeting demand for high-quality adeno-associated virus requires scalable, cost-effective production. The process we developed optimizes each step from suspension cell culture to purified bulk.