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ISOLATOR SYSTEM
Isolation solutions for aseptic fill-finish lines
In the pharmaceutical sector the need to protect the product from contamination due to the presence of personnel or the environment is one of the major drivers for containment. What matters most in aseptic processes is the max. reduction of contamination risk.
In the pharmaceutical sector the need to protect the product from contamination due to the presence of personnel or the environment is one of the major drivers for containment. What matters most in aseptic processes is the max. reduction of contamination risk.
Unique potential. Integrated solutions for processing excellence.
Combined with automated filling systems for liquids or powders, ISOLATION TECHNOLOGY minimizes the direct human intervention in the processing area and is now a technology that is increasingly and rapidly being implemented by the pharma industry.
Internationally recognized 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.
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Sustainability
IMA has always been committed to reducing the environmental impact of its equipment, addressing the issue of consumption through design choices, high-efficiency components and optimizing the control dynamics on processing machines such as isolators. Several active projects are currently under development to exploit the advantages offered by advanced solutions for data collection and analysis in order to reduce consumption. These functions as part of the project “SENTINEL”.
* Specific accelerometric sensors will be installed inside the isolators in order to monitor the ventilation motors and ensure they are functioning correctly.
* In the machines that are part of the fill-finish process (such as filling machines, vial washers, alu-capping machines), specific sensors will be fitted to monitor electrical consumption.
* Additional sets of sensors will be provided for HVAC data collection.
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Production Plant
IMA Life
ISOLATOR SYSTEM 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.
High reliability: engineered for robustness and long-term stability of all functional parameters
4.
Sustainability: designed to reduce operational costs, minimize 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, minimizing operator intervention.
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.
ISOLATOR SYSTEM Gallery
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Complete aseptic filling line for liquid and lyo products
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Complete aseptic filling line for powder drugs and lyo products
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Material Transfer Isolator
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Vial flow, connection with capper
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Isolated line for multi-chamber sterile bags: liquid filling overview
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Internal overview - vial infeed and filling area
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Vial passthrough
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Vial feeding
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Lyo vial loading
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Lyo vial transfer to the capping
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Vial collecting table for lyo loading
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CIP SIP mode – automatic nozzle disconnection