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Litek Pharma Sterility Test Isolator
Safety, Ergonomics, and Maximum Reliability
Litek Pharma’s Sterility Test Isolator is specifically designed to perform sterility testing safely, minimizing the risk of false positives and ensuring that results accurately reflect the true microbiological condition of the evaluated batch. Sterility testing is essential for the release of sterile medicinal products; therefore, having a controlled, stable aseptic environment free from cross‑contamination risks is critical to ensuring quality assurance.
Modular Design
Litek Pharma’s sterility test isolators feature a modular design, allowing the system to be adapted and sized according to each customer’s needs. This flexibility facilitates integration of the isolator into different workflows, as well as the addition of extra modules without compromising ergonomics or sterility.
The system allows the integration of specific equipment and accessories such as sterility test pumps, balances, SART ports, RTP ports, catalytic converters, among others, ensuring maximum operational versatility. In addition, it can be configured with either laminar or turbulent airflow, adapting to any process requirement.
Guaranteed aseptic environment throughout the entire process
The isolator incorporates continuous monitoring of viable and non‑viable particles, as well as temperature and humidity, ensuring permanent control of environmental conditions. An external air handling unit (AHU) is available as an option for environments with critical temperature and/or humidity requirements.
The isolator features an integrated hydrogen peroxide (H₂O₂) generation system, enabling internal decontamination through automated and validated cycles. This ensures the sterility levels required for critical processes while accelerating disinfection times.
Monitoring of critical parameters is directly communicated to the equipment control system, allowing process data to be collected and recorded. This integration facilitates the generation of complete and robust batch reports, reinforcing traceability, process control, and regulatory compliance.
The isolator can also incorporate additional options such as a safe filter change system (BIBO) for specific applications, further enhancing operational safety and process efficiency.
Operator focused ergonomics
To ensure optimal operator ergonomics, a mock‑up will be developed to validate that the isolator provides comfortable and appropriate working conditions. In addition, its ability to perform all processes required by the customer will be verified, and the available space will be assessed to ensure that operations can be carried out safely and efficiently.
Integrated automation and process control
The control architecture is based on an HMI/SCADA platform operated via an industrial touchscreen. Hardware and software are compliant with 21 CFR Part 11 and allow integration with the customer’s SCADA or BMS system, ensuring traceability, data security, and readiness for GMP audits.
The systems integrated into the isolator communicate directly with the equipment’s control system, enabling the collection and recording of critical process data. This integration facilitates the generation of a complete and robust batch report, reinforcing traceability, process control, and regulatory compliance.
Glove and RTP port integrity control with Glove Tester and/or RTP Tester
The sterility test isolator can be equipped with Litek Pharma’s wireless Glove Tester and RTP Tester, enabling verification of glove integrity and leak‑tightness of rapid transfer ports.
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