Drug manufacturing must be a controlled process...
Barrier technologies make it possible to meet this requirement, provided that the design, operation and optimization of the facilities are under control
ISOTEC'XEL supports you in your improvement process
ISOTEC’XEL offers you its expertise in barrier technology.
Isolator, RABS, conventional lines, our knowledge supports you in all aspects of the control of your equipment and industrial processes by following strict compliance with regulatory frameworks (Annex 1 GMP, FDA, etc.).
Specialized in supporting the implementation of new projects, from design to the production of the initial batches, we also carry out revamping studies for existing equipment.
- Design qualification
- Regulatory compliance
- Troubleshooting
- Continuous improvement
- Documentation review
- Field missions
- Qualification Validation
Our expertise
We assist in the design of your barrier technologies (RABS and isolator) or in the revamping of your conventional lines to:
- Guarantee their installation within a controlled timeframe
- Ensure their smooth operation
- Anticipate the control of your manufacturing processes & Participate via field missions in the continuous improvement of your existing units.
- Design and involvement in commissioning stages (design qualification, mock-up projects, etc.)
Management of glove/sleeve and transfer systems
Creation and implementation of decontamination processes
Environmental Monitoring management
Design of your aseptic manufacturing processes
Troubleshooting missions
Conducting risk analyses to integrate quality risk management according to ICH Q9…
- Regulatory audits in connection with Annex 1 of the European GMP and all international regulatory texts
- Comprehensive expertise, process design support and regulatory support for all your activities in a confined environment
- Manual or semi-automatic production of clinical batches in an isolator
- Containment isolator
- Cell therapy/cell culture/viral seeding, etc.
- Handling of cytotoxic products – Handling of radioactive tracers…
Who are we?
Isotec’xel was founded when Patrick Coppens, an expert in isolation technology, met the directors of Theraxel, who together wanted to create a company 100% dedicated to barrier technologies.
Isotec’xel benefits from the support of Theraxel experts, who are involved throughout the life cycle of a medicine or healthcare product to ensure chemical and microbiological contamination is controlled at every stage of the manufacturing chain.
“I joined MSD Clémentel in 1989 and spent almost my entire career at the Riom production site, as Workshop Manager (formulation, filling, freeze-drying, dispensing) for sterile isolator production. I was successfully involved in the installation and continuous improvement of one of the world’s largest isolators for aseptic distribution processes (+100 gloves/cuffs per line).
Over the course of these 30 years, I have acquired a deep understanding of the incredible tool that an isolator can be, and I am happy to now make this knowledge available to our customers who want to design, build, optimize and better control their contained enclosures.”
Patrick Coppens
Isotechnie expert
- 03 80 25 94 30
- 16 Rue Sainte Marguerite 21200 Beaune - France
- contact@isotecxel.fr
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