ISOLATION TECHNOLOGY: Isolation Solutions for aseptic fill finish lines • IMA Group

ISOLATION TECHNOLOGY

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.

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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 Cross 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), we will mount specific sensors to monitor the electrical consumption.
* Additional sets of sensors will be provided for HVAC data collection.

Production Plant

IMA Life

ISOLATION TECHNOLOGY Highlights

1.
Wall isolator – fully integrated on machine base plate – no interface required.

2.
Single wall principle and sloped isolator base plate – improved cleaning.

3.
Fully integrated equipment design and easy access to equipment operating groups.

4.
Highly ergonomic.

5.
Dedicated HVAC System (customized design, flexible, modular).

6.
Customized VPHP cycles.

7.
BAG-IN/BAG-OUT HEPA filters in return ducts in case of toxic products.

8.
Spray nozzles and guns for isolator and equipment cleaning.

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.

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Lab Version

IMA Life production range also includes the ideal solution to perform Sterility Tests, drastically decreasing false positive results.

Designed for QC Labs, pharma production and pharmacies, the IMA Life sterility test isolators are equipped with unidirectional air flow system and guarantee a constant positive pressure gradient between the chambers and the external lab environment.

Technical Data

TBD

ISOLATION TECHNOLOGY Gallery

Complete integrated isolated line for lyo products

Material Transfer Isolator

Vial flow, connection with capper

RTP port

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

Isolated line for multi-chamber sterile bags: powder dosing overview

Internal overview - vial infeed and filling area

Complete aseptic filling line for liquid and lyo products

Internal overview of the filling area

Vial passthrough

Vial collecting table for lyo loading

CIP SIP mode – automatic nozzle disconnection