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The primary uses for our 316L stainless steel isolators are environmental and operator safety.
Pharmaceutical glove boxes are utilised for the filtration, drying, weighing, and chemical synthesis of powders that are hygroscopic, CMR, and active ingredients. Our isolators have the benefit of offering particulate protection in accordance with EN ISO 14644-1 upon request, in addition to operator and product protection.
For every glove box, a customised project management approach including technical assistance, 3D simulations, modelling, QI-QO, FAT, and SAT receptions is suggested.
High-end glove boxes with superior technological performance and finish for safe and rigorous pharmaceutical and medical procedures.
WHY ENTRUST US WITH YOUR ISOLATOR PROJECT?
1. 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 our premises in Lyon, 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…
2. Preferred fields of application in the pharmaceutical and medical sectors
Filtration, drying, weighing, and reconditioning of poisonous or hygroscopic powders while safeguarding workers and goods.
Chemical synthesis, API and HPAPI powder processes, class A isolators, isolators under pure inert gas and controlled atmosphere, OEB 5-6 isolators, aseptic environments, high security containment systems, CMR, cytotoxic, microorganisms and pathogens.
3. Areas of expertise in the pharmaceutical and medical field
Powder process isolators for API and HPAPI, aseptic isolators for class A, automation, WIP, CIP, H2O2 decontamination, optimisation of cleanability and decontamination, HEPA H14 and ULPA filtration, gas management and controlled atmospheres, glove boxes, laminar flow and turbulent flow isolators, nanoparticle cancer drugs, microbiome science, surgical implants, etc.
Additionally, customised design, improved ergonomics, modelling, and arrangement flexibility
Guidelines and norms: adherence to ISO 14644-1 (hygiene), ISO 10648-2 (sealing), GEP and GMP compliance in engineering and manufacturing, FDA 21CFR part.11 automation compliance, GAMP5 computerised systems, and QI-QO qualification.
4. Solutions and exclusive technical aspects
Equipment includes Jacomex mechanical regulation and safety valves, a variety of customised transfer systems (BiBo, DPTE, docking systems, ventilated airlocks and vacuum airlocks).
Resources: For an unmatched level of finish quality, we offer a design and technical department, an industrial manufacturing process with welding robots and specialised technicians, and total control over all phases of development, manufacturing, assembly, and qualification of insulators.
