Isolators for Pharmacy and Medical Applications
Our 316L stainless steel isolators are mainly used in the protection of operators and the environment.
Pharmaceutical glove boxes are used in the filtration, drying, weighing and chemical synthesis of active ingredients, CMR and hygroscopic powders, our isolators offer the advantage of combining protection of operators and products as well as particulate protection according to EN ISO 14644-1 on request.
Tailor-made project management is proposed for each glove box with technical support, 3D simulations, modeling, QI-QO, FAT and SAT receptions.
Technological excellence, performance and highly finished glove boxes for demanding and secure medical and pharmaceutical processes.
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
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.
3. 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.
4. 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 .