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Litek Pharma Containment Isolator
HAPI safety and validation up to OEL5
Litek Pharma’s Containment Isolator creates a safe and controlled environment for operations involving high‑potency active ingredients (HPAPI), combining robust engineering, modularity, and industrial automation to ensure operator safety and process reliability.
Safe environment for operators in high potency processes
Litek Pharma’s containment isolator is designed to protect personnel during the handling of high‑potency products (HPAPI) and critical operations,
while maintaining process integrity with validation up to OEL5 (≤50 ng/m³).
Modular and scalable design
Its modular architecture allows the system to be configured and expanded with modules and components according to the workflow, covering operations from weighing and sampling to loading reactors, drums, IBCs, and other formats.
Optional features and special configurations
The containment isolator can be optionally configured as an aseptic–toxic isolator, combining the highest levels of sterility with advanced containment control. This configuration enables the safe handling of sterile products and hazardous substances, simultaneously ensuring protection of the product, the operator, and the environment, in compliance with the most demanding GMP and safety requirements.
The isolator can also be optionally designed in accordance with ATEX regulations for environments with a risk of explosive atmospheres, adapting to specific process requirements.
The isolator supports HEPA filters in different configurations, such as BIBO (Bag In/Bag Out) or Push‑Push systems, facilitating safe maintenance and filter replacement without compromising containment.
In addition, it can be equipped with RTPs (Rapid Transfer Ports), split butterfly valves for the safe introduction and removal of materials, or drum lifters to optimize ergonomics and safe handling, among other options.
The system also offers the possibility of integrating WIP/CIP systems for automated cleaning and features a fully drainable chamber, facilitating effective cleaning and sanitization processes.
Process equipment integration
The containment isolator allows the integration of weighing systems, solid transfer systems, micronizers, sieves, milling discharge systems, and connections to dryers, lyophilizers, or autoclaves, among others, while maintaining full containment.
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.
Integrity control with Glove Tester & RTP Tester
Litek Pharma’s containment isolator can be equipped with Litek Pharma’s wireless Glove Tester and RTP Tester , enabling verification of glove integrity and leak‑tightness testing of rapid transfer ports.
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