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.
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.
A common question related to aerosol particle counters is how well particle counting results should match each other. An example of when this becomes important is new particle counters being added to an existing fleet. The new instruments could be supplied from the original manufacturer or from a new vendor. 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.