SECTORS WITH STRONG REGULATORY CONSTRAINTS
PERFORMANCE
COMPLIANCE
INNOVATION
Objectives and activity
Our objective: boost your overall productivity by improving your productivity and the quality of your processes.
We take into account the most recent local regulations (ISO 14644-1) along with building protocols and working environments. We focus on sectors and industries with high regulatory contraints.
Pharmaceuticals & Health
Your needs
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Clean rooms are fundamental in the production of pharmaceuticals.
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At ISALYS CleanRoom, we are aware of industry standards and we thrive to meet these standards and go beyond them to assure that your tailor-made solutions can help you produce your pharmaceutical goods with the proccesses that you are used to.
Our commitments
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Analysis and design of traffic flows and utility networks
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Compliance with ANSM, EMA, FDA, ANVISA, PLVA authorities
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Control of building and safety constraints in accordance with GMPc/BPF
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Management of regulatory qualifications
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Selection of pharmaceutical laboratory equipment
Biotech
Your needs
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The substances handled in biotechnology are in the micrometre or nanometre range.
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Without the cleanroom, particles in the unpurified air, which can be much larger, can attach themselves to these tiny substances, which can impair their quality or performance.
Our commitments
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Protection of personnel who may be contaminated
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Control of the risks of contamination of micro-organisms to the outside world
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Guarantee of the framework of chemical or bacteriological experiments carried out
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Mobilization of the group's expertise (gene therapy, genome sequencing or stem cells)
Agri-food
Your needs
The food industry is subject to the constraints of clean rooms in the industrial premises where foodstuffs are processed. The slightest error would cause contamination on a scale that is difficult to control; the controlled environments at the heart of this industry contribute to the protection of human health.
Our commitments
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Guarantee of perfect protection of processed products
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Provision of cold chain control solutions.
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Design of processes to control the use of preservatives
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Integration of storage and processing constraints according to the products
High tech & Electronics
Your needs
The high-tech sector requires cleanrooms and associated controlled environments in which it is necessary to control the concentration of airborne particles, temperature, humidity and pressure.
Our commitments
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Choice of materials to protect your components with conductive and antistatic finishes
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Proposal of fireproof solutions
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Mastery of the noise standards in force
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Selection of chemical resistant solutions
Cosmetics
Your needs
Cosmetic products are intended to be placed in contact with the superficial parts of the human body; their production requires the setting up of rooms in controlled environments of the highest level.
Our commitments
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Compliance with good manufacturing practices in cosmetics (ISO 22716)
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Agility to support your product renewals
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We guarantee compliance with the most recent international regulatory requirements
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Ensures ad hoc regulatory monitoring