TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. Whether you periodically certify your clean areas or monitor them, TSI products help simplify your task. Aerotrak™ Portable Particle Counters offer an simple icon driven touch screen interface, making it easy to set up and operate. TSI’s FMS 5 Facility Monitoring Software incorporates Aerotrak™ Remote Particle Counters, environmental sensors and real time alarms whilst enabling FDA 21 CFR part 11 compliance. With headquarters based in the U.S. and field offices throughout Europe and Asia, TSI has established a worldwide presence in the markets we serve.
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TSI introduces a new range of AeroTrak®+ Remote Airborne Particle Counters (APCs) for monitoring manufacturing cleanrooms. TSI is so confident about the performance of the new laser technology inside, that all models are covered by an industry-exclusive standard 5 year laser warranty.
Investigations of airborne viable excursions in cleanrooms using traditional techniques notoriously fail to identify a definitive root cause. What if this information were available in real-time when the contamination event occurred? This video introduces real-time viable particle monitoring and how it can quickly identify the source of a contamination.
While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.
Real-time viable particle monitoring instruments have been available for over five years. This white paper intends to describe this technology and how it is used to detect viable particles in real-time.
Investigations of airborne viable excursions in cleanrooms using traditional techniques notoriously fail to identify a definitive root cause. No matter how extensive the investigation, due to the limitations of the traditional tools available, luck often plays a large role in actually identifying an elusive "smoking gun".
For years the practical metric of airborne microbial contamination was the colony forming unit. Adapting growth-based approaches for monitoring today's aseptic manufacturing has sometimes proven difficult.
Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe.
A facility monitoring system is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime.
The BioTrak Particle Counter instantly detects microbial contamination, a vast improvement over century-old culture-based methods.
TSI Incorporated, the leader in continuous particulate monitoring instrumentation, recently expanded its offering to include remote particle counters with an integrated pump.
The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.
TSI Incorporated, the leader in continuous airborne monitoring solutions, released a new line of remote particle counters resistant to the damaging effects of Vaporized Hydrogen Peroxide (VHP.) Designed with VHP-resistant coatings and materials, the TSI AeroTrak® Remote Particle Counter 7510-VHP series is ideal for GMP manufacturing applications where accidental VHP exposure can occur.
In this, the third and final in a series of application notes to assist end users in understanding the guidance detailed in EU GMP Annex 1, section 8 onwards will be covered detailing cleanroom and clean air device monitoring. By TSI Incorporated
The BIOTRAK Particle Counter is a full-featured instrument that detects the total number of particles in the air as well as determines which of those particles are viable in nature.
Rapid microbiological methods (RMM) have been around for many years but have yet to make a significant impact on pharmaceutical manufacturing processes despite the advantages they offer in terms of cost savings and process improvement. By Darrick Niccum, senior global product manager-biotechnology, TSI Incorporated
Change is around the corner for pharmaceutical cleanrooms, as significant revisions to current ISO particle counting standards are forthcoming. With this in mind, Pharmaceutical Online thought it was a good time to speak with Troy Tillman of TSI, a supplier of particle counters and other precision measurement solutions.
When specifying particle counters for continuous monitoring applications, such as pharmaceutical aseptic manufacturing processes, there are many system design decisions to be made.
This article is the second in a series of three application notes to assist end users in understanding guidance detailed in EU GMP Annex 1. In this installment, detailing cleanroom and clean air device classification is covered.
As many of you already know, when a particle counter continuously monitors an aseptic manufacturing process, it is positioned to detect potential harm to the product.
Part 4 of ISO 21501, “Light scattering airborne particle counter for clean spaces,” applies to handheld, portable and remote airborne particle counters used in cleanrooms.
This is the first in a series of three articles on EU GMP Annex 1 and particle counting. These articles are designed to assist an end user in understanding the guidance detailed in EU GMP Annex 1 when classifying or monitoring particle cleanliness in clean spaces as well as in pharmaceutical and life science applications. By TSI Incorporated
The laser induced fluorescence signatures generated from environmental particles are complex. It is a challenging task to discriminate viable from non-viable particles that have fluorescence characteristics. By Darrick Niccum, senior global product manager-biotechnology, TSI Incorporated
This application note will demonstrate how real-time viable particle count data will lead to improved root cause investigations when a BIOTRAK Particle Counter is integrated into an FMS system.
The BIOTRAK Real-Time Viable Particle Counter is a full-featured Rapid Microbial Method (RMM) instrument that detects the total number of particles in the air as well as determines which of those particles are viable in nature.
A non-viable airborne particle counter is a misnomer. Current airborne particle counting technology such as found in the TSI AEROTRAK™ particle counters, size and count all particles that pass through its viewing volume, it does not matter whether the particle is viable or non-viable.
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
A facility monitoring system is a process monitoring tool that collects data from sensors called particle counters. Over time, as reliability of particle counting instruments evolves, this creates opportunities to implement real-time quality control strategies. This leads to quality-based monitoring and immediate decision-making to reliably produce high quality drugs without excessive regulatory oversight.
At Interphex 2014, Todd and Todd interview Tim Russell, Field Market Developer with TSI Incorporated to discuss how to detect potential contamination events before they occur.
ISO 21501 is titled “Determination of particle size distribution – Single particle light interaction methods” and consists of 4 parts. Part 4: Light scattering airborne particle counter for clean spaces applies to handheld, portable and remote airborne particle counters used in cleanrooms.
This application note details key design considerations when implementing VHP resistant continuous particle counters in critical GMP controlled cleanroom environments.