Measures Particle Charge and Concentration

The Aerosol Electrometer 3068B from TSI Incorporated offers unmatched precision in measuring electrical current and flow rate of aerosol particles, ranging from 0.002 to 5 µm. Paired with a TSI Electrostatic Classifier, it excels in calibrating and testing particle instruments, crucial for nanotechnology and environmental sciences. Outputs are available via RS-232 and USB, providing real-time data critical for particle charge and concentration studies. It boasts a wide dynamic range (±12,500 fA) and increased sensitivity (±1 fA), outperforming its predecessor, Model 3068A. Designed for easy integration into existing systems, the electrometer’s automatic flow control (0.3 to 10 L/min) and temperature stabilization minimize drift, ensuring reliable long-term measurements. Ideal for use in pharmaceutical, chemical, and air quality testing industries, it supports operations in continuous and bench-top modes. The device requires a vacuum source for operation and is integral to submicron filter-efficiency tests and emission testing applications.

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Monitors and Detects Viable Particles in Real Time

The BioTrak Model 9510-BD from TSI is a cutting-edge viable particle counter designed for continuous, automated monitoring in aseptic environments. Leveraging biofluorescent particle detection, it distinguishes viable from inert particles, ensuring real-time monitoring of vital environments, such as pharmaceutical and biopharmaceutical production facilities, with exceptional precision. Particularly beneficial for vaccine manufacturing and sterile product production, it enhances environmental monitoring by reducing the need for aseptic interventions and supporting root cause investigations.

Operating with a 1 CFM (28.3 L/min) sample flow rate, the BioTrak integrates seamlessly into your current facility monitoring systems using the TSIFMS Software for automated data collection and analysis. The system supports compliance with GMP regulations by maintaining data integrity in accordance with 21 CFR Part 11 standards, and is further supported by the ALCOA+ principles in Data Integrity Mode. The standalone capability aids in rapid contamination source identification, room release, and risk assessment, while its stainless steel enclosure and HEPA-filtered exhaust ensure minimal maintenance and robust operation.

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Processes and Lyophilizes Aseptic Vial Fillings

The Sterile Lyophilised Vial Filling Line from Telstar offers cutting-edge solutions for pharmaceutical and biotech companies needing precision in aseptic processing. This line integrates seamless vial filling with advanced lyophilization, ideal for high-potent drugs like monoclonal antibodies and mRNA vaccines. Featuring an automatic row-by-row single-side push-in/pull-out system, it ensures efficient loading and unloading. The system incorporates SCADA for comprehensive process control and real-time monitoring, optimizing production efficiency. Designed with a mushroom-type chamber-condenser isolation valve, it excels in solvent handling and vacuum processing, minimizing contamination risks. The equipment meets stringent GMP standards, ensuring compliance for pharmaceutical applications. With integrated CIP and SIP systems, it offers enhanced cleaning and sterilization efficiency, reducing downtime and ensuring product safety. Customization options cater to specific production needs, supported by expert engineering support from Telstar.

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Ensures Aseptic Filling and Sterility

The Single Chamber 4 Glove Aseptic Isolator from Telstar is engineered for pharmaceutical and biotechnology applications requiring stringent aseptic conditions. This isolator features an integrated H2O2 bio-decontamination system, ensuring a contamination-free environment for the production of preservative-free eye drops, sterile APIs, and injectable syringes. The system’s single working chamber, equipped with adjustable height and comprehensive viable and non-viable monitoring, allows precise handling of pharmaceutical processes. Its automation capabilities, reinforced by integrated monitoring, support seamless insertion into existing production lines, optimizing both throughput and sterility assurance. Constructed with corrosion-resistant materials, the isolator meets GMP standards and is designed for ease of cleaning and maintenance, offering long-term reliability and efficiency in sterile manufacturing environments.

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Facilitates Secure Bio-Decontamination and Sterile Transfer

Telstar’s SAS Pass Through Boxes are engineered to enhance the bio-decontamination and sterile transfer process within pharmaceutical and biotech production facilities. These systems specialize in securely moving materials between different classified areas, pivotal for manufacturing sterile injectable drugs and regulated biologics. The SAS Pass Through Boxes, including the Biological SAS ION HP+ and HEPA Filtered SAS variants, utilize advanced filtration and bio-decontamination technology. The Biological SAS ION HP+ integrates an ionHP+ hydrogen peroxide decontamination system, co-developed with sterilant experts, ensuring a minimum 6-log reduction in microbial spores without preconditioning of standard temperature and humidity. Configurations accommodate various production line layouts with options for multiple doors and configurations in L-shape. Compliance with GMP standards ensures integration into highly regulated environments. Customizable features such as transfer trolleys and catalytic devices, alongside robust SCADA control systems, enable seamless operations and reporting. These units are rigorously designed to support stringent pharmaceutical processes, making material handling efficient, safe, and compliant with industry regulations.

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