Engineering dedicated to your controlled environments!
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Who We Are
Q.2.E.S.B Ingénierie is a firm specializing in the expertise, design, construction, and qualification of cleanrooms. Founded in 2021, our company has rapidly established itself as a key player in the engineering sector, thanks to its expertise and its commitment to excellence.
Our team consists of highly qualified engineers and experts, each with more than 15 years of experience in their respective fields. This extensive expertise enables us to provide innovative solutions that are perfectly tailored to the specific requirements of our clients and partners.
Q.2.E.S.B Ingénierie offers a wide range of services for industrial sectors in Tunisia and abroad. Our team primarily works on the design, construction, and qualification of cleanrooms, anhydrous rooms, and controlled environments (liquid and dry forms, medical devices, automotive, and microelectronics), as well as on air treatment system studies and implementation, CEO-CFA studies, environmental impact assessments, hazard studies, energy audits, and fire safety studies.
Our Engineering Services for Controlled Environments
From design to qualification, we provide turnkey support for the development of your cleanrooms and controlled-atmosphere areas, backed by a wide range of expertise and a strong command of applicable standards (ISO 14644, NF S 90-351, NF ISO 17141, GMP, etc.).
Cleanroom Qualification
We ensure the regulatory compliance of your controlled-atmosphere areas by carrying out all required qualification activities (IQ / OQ / PQ). In strict accordance with pharmacopoeias and GMP requirements, our team of experts handles all critical tests, including decontamination kinetics, filter integrity, air-handling parameters, and microbiological testing.
Airflow Studies and Modeling
We leverage the power of Computational Fluid Dynamics (CFD) simulation to support your projects. Our engineers and PhD experts model your airflow patterns in 3D to eliminate dead zones and anticipate any risk of contamination. We therefore design high-performance HVAC systems tailored to your budget and compliant with pharmaceutical standards.
Energy Audit
Accredited by ANME for the industrial sector, Q2ESB conducts comprehensive and regulatory energy audits of your critical systems (steam, cooling, compressed air, unit processes). We combine rigorous measurement with strategic consulting to reduce your energy footprint and optimize your production costs.
Our Strengths
Over 10 years of cleanroom expertise and a deep understanding of our clients’ processes and constraints
Tailor-made project engineering, with guaranteed independence for project owners
Proactivity, proximity, and responsiveness
Our Areas of Expertise
Pharmaceutical Industry & Fine Chemicals
We have extensive expertise in the GMP requirements applicable to solid dosage forms (tablets, capsules), liquid forms (injectables, oral solutions), sterile products, and fine chemical APIs. Our services cover the design of Class A to D cleanrooms (EU-GMP), qualification of critical HVAC systems, and support during regulatory inspections (INPHB, ANSM, FDA).
Healthcare & Biotechnology
Operating rooms, intensive care units, and hospital pharmacies require strict levels of particulate and microbiological cleanliness. Q2ESB designs and qualifies these environments in accordance with NF S90-351 and ISO 14644, while taking into account the specific requirements of hospital operations (continuous operation, architectural constraints, and coordination with medical teams).
Q2ESB leverages all its expertise and know-how to serve its clients.
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Our References
Your Project Deserves Proven Expertise
Whether you are planning the construction of a new cleanroom, the requalification of an existing controlled environment, or the optimization of your HVAC systems, the Q2ESB team is here to support you. Our engineers analyze your requirements, assess your regulatory constraints, and provide you with the most suitable solution.
FAQ — Cleanroom Qualification
The questions our clients most frequently ask before starting a project.
What is a cleanroom?
A cleanroom is a controlled-contamination working environment. Governed by ISO 14644, it is designed to minimize the introduction, generation, and retention of airborne particles. Through a high-performance air filtration system, this environment also enables precise control of critical parameters such as airflow, temperature, and humidity.
What is the difference between ISO 7 and ISO 8?
The main difference lies in the level of air cleanliness. An ISO 7 cleanroom is 10 times cleaner than an ISO 8 cleanroom: it allows a maximum of 352,000 particles per m³, compared with 3,520,000 for ISO 8. To maintain this level, ISO 7 requires a higher air change rate (30 to 60 air changes per hour compared with 15 to 25 for ISO 8).
The choice depends on the sensitivity of your process: ISO 8 is suitable for secondary packaging or standard assembly, while ISO 7 is required for highly critical operations (electronic chips, injectable solutions).
How does particle measurement ensure cleanroom classification?
Cleanliness classification is based on rigorous monitoring of the particle concentration in the air. These measurements are generally performed using a laser particle counter, ensuring that the maximum thresholds defined by ISO standards or GMP guidelines are not exceeded. This strict monitoring makes it possible to validate the area's compliance and maintain the required level of cleanliness to protect the most sensitive production and research processes.
Why is cleanroom qualification necessary?
The purpose of cleanroom qualification is to demonstrate, through documented evidence, that the facility is fully suitable for its intended use and protects the integrity of products or processes. This systematic approach verifies that the cleanroom has been designed, constructed, installed, and operated in full compliance with user requirements and applicable regulations.
How often does a cleanroom need to be requalified?
The regulatory frequency depends on the cleanroom's cleanliness class (ISO 14644-2):
- Every 6 months for the most stringent cleanrooms (ISO 5 and below / GMP Grades A and B).
- Every 12 months for standard cleanrooms (ISO 6 to ISO 9 / GMP Grades C and D).
Immediate requalification is required in the event of an anomaly, modification to the cleanroom, or replacement of HEPA air filters.
What is EU-GMP Annex 1 (2022), and what are its implications for cleanrooms?
The revised Annex 1 of the European Good Manufacturing Practices (published in 2022 and applicable since August 2023) strengthens the requirements for the manufacture of sterile medicinal products. It requires the implementation of a documented Contamination Control Strategy (CCS) and strengthens requirements relating to cleanroom classification, environmental monitoring, and equipment qualification. Q2ESB supports its pharmaceutical clients in complying with this new version, particularly with qualification documentation and the review of their CCS.
How long does a cleanroom project take, from design to qualification?
For a medium- to large-scale facility (500 to 1,500 m²), the overall timeline generally ranges from 8 to 14 months, divided into three successive phases:
- Studies and design (3 to 4 months): requirements analysis, detailed engineering, and sizing of air-handling systems.
- Construction and installation (4 to 8 months): construction of the cleanroom envelope, installation of filtered ceilings, HVAC connections, and utility systems.
- Qualification (1 to 2 months): regulatory compliance testing (IQ / OQ / PQ) required before production can begin.
Depending on your resources and requirements, Q2ESB can support all or part of these stages, either through turnkey project management or through targeted consulting and technical assistance services.
Do you operate only in Tunisia, or do you also work internationally?
Q2ESB has two locations: one in Tunisia (Tunis, El Agba Industrial Zone) and one in France (Paris, Boulevard de Sébastopol). We regularly operate across the Maghreb (Morocco, Algeria) and Europe. Our Prodimedic project in Morocco (12,000 m²), as well as our collaboration with international clients, including We Control in France, demonstrates our ability to manage complex projects across multiple countries simultaneously.