ISOLATOR SYSTEM Aseptic Processing

Machine overview

Unique potential. Integrated solutions for processing excellence.

Combined with automated filling systems for liquids or powders, ISOLATION TECHNOLOGY minimises direct human intervention in the processing area and is now a technology that is increasingly and rapidly being implemented by the pharmaceutical industry.
Internationally recognised as an expert in advanced aseptic processing applications, IMA Life has gained a wealth of experience in contamination control and can offer a solid understanding of the risks associated with the handling of potent and cytotoxic compounds.

Production plant

IMA Life

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Machine highlights

  1. Compliance

    Fully compliant with all major standards and guidelines for aseptic injectable drug production, including the latest EU GMP Annex 1, FDA guidance on sterile drug manufacturing, ISPE, PIC/S, and PDA recommendations.

  2. Flexibility

    Highly configurable to suit any layout and machine configuration meeting customer’s needs in terms of productivity and operational flexibility.

  3. Excellent reliability

    Engineered for robustness and long-term stability of all functional parameters

  4. Sustainability

    Designed to reduce operational costs, minimise energy consumption, environmental impact and carbon footprint.

  5. Adaptability

    Designed to meet URS requirements for environmental conditions, including specific temperature/humidity setpoints, cold filling/loading and inert atmosphere control.

  6. Multi-role and high-containment ready

    Can be configured for high-containment production, suitable for handling high-potent, cytotoxic or biologically hazardous drugs.

  7. Process automation

    Ensures maximum risk mitigation with fully validated and automated procedures, such as decontamination, Wash-In-Place, and deactivation, minimising operator intervention.

Benefits

The use of this technology on filling machines offers clear economic advantages and operating benefits, assuring higher product sterility levels in addition to improved operator safety.

Machine details

Machine video trailer

Complete aseptic filling line for liquid and lyo products

Complete aseptic filling line for powder drugs and lyo products

Material Transfer Isolator

Vial flow, connection with capper

Isolated line for multi-chamber sterile bags: liquid filling overview

Internal overview – vial infeed and filling area

Vial feeding

Lyo vial loading

Lyo vial transfer to capping

Vial collecting table for lyo loading

CIP-SIP mode – automatic nozzle disconnection

IMA Life | The Unique Potential

Containment. Compliance. Modularity. Fitting an unlimited number of modular layout configurations, IMA Life isolated fill-finish solutions ensure the necessary versatility to adjust the production process according to your needs and maximise line performance up to 600 units/min. with 100% In-Process Control.

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