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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Separates Operators from Critical Aseptic Environments

Telstar’s Restricted Access Barrier Systems (RABs) are designed to optimize aseptic processing by creating a high level of separation between operators and critical environments in pharmaceutical production. These systems are essential for manufacturing sterile injectable drugs, vaccines, and various biologics, offering a unique combination of physical barriers and dynamic airflow. RABs can be tailored to integrate with third-party equipment, ensuring compliance with GMP and current regulatory standards. They feature unidirectional laminar flow (active RABs) to maintain an ISO 5 positive pressure environment, crucial for protecting sensitive processes. With aseptic transfer capabilities for powders and liquids, and advanced environmental monitoring systems, these units are ideal for cleanrooms requiring enhanced sterility without the need for fully leak-tight isolators. Telstar supports customization and offers technical assistance, ensuring the RABs meet specific operational needs while facilitating ease of cleaning and maintenance through integrated systems.

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For ultimate containment of all API and potent compounds, where the containment capability is crucial

The Half-suit tester from Telstar life-Sciences is the most likely component of the isolator which mission is to suffer wear and tear and thus develop leaks. Due to it works in the critical zone, guarantees special attention at the design stage and when monitoring protocols are developed.

The containment capability of half-suits is therefore as crucial as any other part of the integrated system, and a simple, accessible means of checking interface integrity is critical.

Telstar ACE offers custom-built testing systems to enable fast, easy measurement of half-suit containment efficiency. The Telstar Half-suit Tester is designed to allow both in situ and offline testing.

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