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Isolator for pharmacy and medical applications

G[Iso] Glove Box Workstation
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Jacomex-Made-in-France[99]
HIGH SECURITY ISOLATOR 

Customised isolator for any process in the pharmaceutical and medical sector. 

Jacomex is the ideal partner for the pharma and medical sector requiring enhanced protection of operators, products and the environment. For all operations involving toxic powders, CMR, hygroscopic or oxidizable active ingredients, the G(Iso) is an isolator model offering simultaneous protection of the operator (operation in depression) and protection of the product (operation under neutral gas ). 

The perfect expertise of Jacomex stainless steel boilermaking allows us to offer technical solutions and a finish in perfect harmony with the issues of clean-ability: rounded corners, surface treatment, secure waste management, filter replacement bag-in-bag- out …

APPLICATIONS

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DIMENSIONS

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ADVANTAGES
▼ Custom design
▼ Operators-products-environment protection
▼ Customised project follow-up:
    Technical support, 3D drawings simulation, technical and ergonomic configuration approval
▼ Equipment fully adjustable according to the application:
     • Filters: HEPA H13-H14 or ULPA
     • Transfer systems: airlock – bag-in-bag-out – RTP
     • Controlled atmosphere: moisture (0-70%RH) and/or oxygen control
     • Operator security: JACOMEX pressure regulation and security valve
     • Particule cleanliness according to ISO 14644-1 (class ISO5 when not operating)

 

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POSSIBLE APPLICATIONS...
▼ Quality control, Galenic R&D
▼ Scaling and packaging of toxic and hygroscopic powders
▼ Chemical synthesis and manipulation of active principles, cytotoxic and OEB4 – OEB5 products
▼ Surgical implants manufacturing for the medical field
▼ Development of nanoparticulate anti-cancer active ingredients
▼ Microbiome science

TECHNICAL DATA
▼ Tightness Class 1 according to ISO 10648-2 (oxygen method)
    Leak rate < 5.10E-4/h (0.05 Vol%/h)
▼ Gaskets: EPDM – silicone FDA
▼ Rounded corners chamber: stainless steel AISI 304L – AISI 316L Surface finish: electropolished
▼ Front panel: mineral laminated glass
▼ Roof lighting (LED spotlights)
▼ Easy-to-clean stainless steel shelves
▼ 1 electrical feedthrough 230V + 2 ISO KF40 blank feedthroughs
▼ Glove rings: stainless steel
▼ Interface: 7’’colour touch-screen
▼ Automatic pressure regulation

 

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Flexibility – Reactivity – Efficiency

Our services are all hosted without exception on our premises in one and the same place. During all the phases of a project, this organization results in great flexibility, high quality exchanges and sharing of ideas as well as a dynamic and effective working partnership.

In Jacomex premises in France, over the course of your project, you will come into contact with the Sales, Engineering, Design Office, Quality Management, Technical and R&D Department, Project Managers, Stainless Steel Boilermaking Workshop, Manufacturing and Assembly, Automation and Process, Reception and Qualification teams…

Preferred fields of application in the pharmaceutical and medical sectors

Protecting operators and products, filtration, drying, weighing, reconditioning of toxic or hygroscopic powders.

Chemical synthesis, API and HPAPI powder processes, CMR, cytotoxic, micro-organisms and pathogens, aseptic environments, high security containment systems, OEB 5-6 isolators, aseptic environments, ISO 14644-1 clean environments, class A isolators, isolators under pure inert gas and controlled atmosphere.

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Areas of expertise in the pharmaceutical and medical field

API and HPAPI powder process isolators, aseptic isolators, class A isolators, automation, WIP, CIP, H2O2 decontamination, optimization of cleanability and decontamination, HEPA H14 and ULPA filtration, gas management and controlled atmospheres, glove boxes and turbulent flow isolators, turbulent flow and laminar flow isolators, nanoparticle cancer drugs, microbiome science, surgical implants…

Plus: tailor-made design, enhanced flexibility of use and ergonomics, modeling and layout

Norms and standards guidelines: compliance with ISO 14644-1 (cleanliness), ISO 10648-2 (sealing), engineering (GEP) and manufacturing (GMP) compliance, FDA 21CFR part.11 automation compliance and GAMP5 computerized systems, QI-QO qualification.

Solutions and exclusive technical aspects

Equipment: varied and adapted transfer systems (BiBo – DPTE – docking systems – ventilated airlocks – vacuum airlocks), Jacomex mechanical regulation and safety valves

Resources: We have a design and technical department at your disposal as well as a unique and industrial manufacturing process with welding robots and specialized technicians for an unrivaled quality of finish, complete control of all stages of development, manufacturing, assembly and qualification of insulators .

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They Trust Jacomex
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