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TSI
Pharma-Life Science brochure

Pharma-Life Science brochure

Product catalog summary

Overview: This document outlines the environmental monitoring solutions provided by TSI Incorporated for pharmaceutical manufacturing and life sciences. It emphasizes the importance of reliable and confident monitoring systems that comply with global good manufacturing practices and standards such as EU Annex 1, FDA guidance, and ISO standards.

Specifications and Standards: The document references key standards including Annex 1 for sterile medicinal products, FDA guidance for aseptic processing, and ISO 14644-1:2015, 14644-2:2015, and 21501-4:2018. These standards ensure compliance and data integrity in monitoring systems.

Facility Monitoring System (FMS): TSI's FMS is described as a distributed, flexible, and redundant system with no single point of failure. It is scalable and ready for Pharma 4.0 with OPC UA Client/Server communication. The system ensures data availability and security with SQL databases and mirror redundancy.

Environmental Monitoring Products: The document details various particle counters and monitoring devices:

Airborne Particle Counters: Designed for different pharmaceutical environments, ensuring compliance with ALCOA+ data integrity principles and 21 CFR Part 11.
BioTrak® Real-Time Viable Particle Counter: Provides continuous viable monitoring, reducing interventions in Grade A environments.
AeroTrak®+ Remote and Portable Particle Counters: Offer ultra-reliable data collection with features like VHP resistance and Wi-Fi communication.
Active Air Sampler: Suitable for aseptic environments, meeting ISO 14698 and EN 17141 requirements.

Data Management: The system includes fault-tolerant design, hot-standby options, and secure data storage with redundancy. It supports multiple clients and provides tools for data analysis, alarming, and reporting.

Key Benefits: The document highlights benefits such as compliance, data integrity, ease of use, and profitability, while reducing risk, downtime, cost, and waste.

Contact Information: TSI Incorporated provides contact details for various regions including the USA, UK, France, Germany, India, China, and Singapore.

Catalog excerpts

Reliable. Confident. Environmental Monitoring. Pharmaceuticals | Life Sciences Global Good Manufacturing Practices ▪ nnex 1 (EU, PIC/S, WHO): Manufacture of A Sterile Medicinal Products ▪ DA Guidance for Industry - Sterile Drug F Products Produced by Aseptic Processing ISO 14644-1:2015, 14644-2:2015 & 21501-4:201

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Reliable. Confident. Environmental Monitoring. Airborne Particle Counters TSI® Facility Monitoring Software: Reliable Monitoring Systems Confident Results Matter ▪ odels for every pharmaceutical environment M and application ▪ LCOA+ data integrity principles for no-hassle A 21 CFR Part 11 compliance ▪ eading the way in real-time viable L particle detection BioTrak® Real-Time Viable Particle Counter The Future of Viable Monitoring ▪ Reduce or eliminate interventions in Grade A ▪ Achieve truly continuous viable monitoring ▪ Accelerate investigations with real-time data Distributed. Flexible. Redundant....

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Reliable. Confident. Environmental Monitoring. Environmental Monitoring Products for Pharmaceutical Manufacturing & Life Sciences Facility Monitoring System A reliable monitoring system that ensures environmental control and decreases downtime — Pharma 4.0 plug and play functionality via OPC UA Client/Server Model Flow Rate Remote Particle Counters Designed for continuous monitorinig as part of the Facility Monitoring System AeroTrak®+ 7510 AeroTrak® 6510 VHP resistant models available, Wi-Fi® capable with optional module Portable Particle Counters Versatile instruments suitable for classification...

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