Pharmaceutical isolator

asepticcontainmentfilling

Overview
ISOLATOR SYSTEM is an aseptic isolator engineered to minimise direct operator intervention and contamination risk in sterile fill-finish processes. Designed for integration with automated filling lines, it supports liquids, powders and lyophilized products while enabling high-containment handling of potent and cytotoxic compounds.

Machine overview
The ISOLATOR SYSTEM provides a controlled enclosure for aseptic processing and containment. It is configurable to match production layouts and validated process flows, enabling environmental control (temperature, humidity, inert atmosphere) and cold filling/loading where required.

Key highlights

• Regulatory alignment: designed to comply with EU GMP Annex 1, FDA sterile manufacturing guidance and industry recommendations (ISPE, PIC/S, PDA).
• Configurable containment: supports high-potency and cytotoxic handling with modular containment solutions.
• Process automation: integrates validated automated cycles (decontamination, WIP/CIP/SIP, deactivation) to reduce manual interventions.
• Operational flexibility: adaptable layouts and interfaces for upstream/downstream equipment integration.
• Performance focus: engineered to maintain stable functional parameters and sustained throughput in validated configurations.

Benefits

• Improved sterility assurance and reduced contamination risk for sterile injectables.
• Enhanced operator safety for high-containment manufacturing.
• Operational and economic efficiencies through automation and modular design.

Gallery / Media
Includes images and a machine video trailer illustrating isolated fill-finish line configurations: isolated vial passthroughs, material transfer isolators, vial feeding and lyophilizer loading stations for liquids, powders and lyophilized products.

Technical specifications

• Standards: EU GMP Annex 1, FDA sterile manufacturing guidance, ISPE, PIC/S, PDA recommendations.
• Applications: aseptic filling of vials, syringes and multi-chamber bags for liquids, powders and lyophilized products.
• Containment: configurable for high-containment/high-potency/cytotoxic processing.
• Automation: supports fully validated automated cycles (decontamination, CIP/SIP, WIP, deactivation).
• Environmental control: temperature and humidity setpoints, inert atmosphere control, cold filling/loading support.
• Throughput: up to 600 units/min with 100% in-process control in appropriate configurations.
• Installation: modular layouts adaptable to customer URS and plant constraints.