Testing and Qualification of Equipment and Micro-Environments
In demanding industries such as pharmaceuticals, microelectronics, food processing, and healthcare, cleanroom qualification is a fundamental guarantee of product safety, process reliability, and regulatory compliance. A cleanroom or controlled environment is a controlled space where airborne particle concentrations are managed, but its mere existence is not enough. It is essential to demonstrate and document that the environment operates as intended and complies with the strict standards in force.
Q2ESB Ingénierie, with more than a decade of proven experience, is your expert partner for the complete qualification of your cleanroom facilities. Our multidisciplinary team of specialized engineers and technicians has extensive expertise in Good Manufacturing Practices (GMP) and key reference standards such as the ISO 14644 series, ISO 14698, and NF S90-351. We are committed to delivering high-quality services precisely tailored to your specific requirements and the latest regulatory developments.
Cleanroom Qualification Tests
Cleanroom qualification is based on a series of standardized, documented, and reproducible tests. Each test is performed according to the protocols defined by ISO 14644, GMP, and Good Manufacturing Practice (GMP) guidelines, and is documented in a fully traceable audit report.
Filtration Integrity Testing
Verification of terminal filter integrity using the PAO method in accordance with ISO 14644-3. This test is required whenever a filter is replaced and during periodic requalification.
Airflow Testing
Measurement of air velocities and air change rates verifies that the HVAC system delivers the conditions defined in the design specifications. An insufficient air change rate can directly compromise the ISO classification of the area.
Particle Counting
Particle counting determines the ISO classification of the area (ISO 5 to ISO 8) in accordance with the statistical protocols of ISO 14644-1. Decontamination and recovery testing measures the cleanroom's ability to return to its specified classification after a disturbance.
Microbiological Testing
Air sampling and surface monitoring are carried out in accordance with NF EN 17141 and the revised 2022 Annex 1 of the GMP guidelines.
Acoustic and Lighting Measurements
These tests, required by NF S 90-351, apply primarily to operating rooms, laboratories, and patient care areas. They complement the qualification documentation for healthcare facilities and ensure operator comfort and safety.
Test Sheet List
The test sheets are identified according to the assessed risks and organized as follows:
Installation Qualification (IQ)
| Test Type | Test Objective | Acceptance Criteria | Sheet No. |
|---|---|---|---|
| Identification based on the installation drawings and P&IDs | Verification of the identification and integrity of HVAC components and verification that the associated technical data sheets are available | All listed HVAC components are identified, intact, and their technical data sheets are available | FE-QI-001-A |
| HVAC system installation | Verification of the overall condition of the HVAC system (installation, cleanliness, etc.) | No anomalies are observed (ductwork tightness, insulation, airflow direction markings, etc.) | FE-QI-002-A |
| Monitoring System | Verification of the overall monitoring system operation and the presence of all required components | All alarms and operating states/parameters from all components are correctly transmitted to the central monitoring system | FE-QI-003-A |
| Cleanroom Enclosure Installation | Verification of the overall condition of the enclosure (installation, cleanliness, etc.) | No anomalies are observed (corners, damage, unsuitable materials, dirt, etc.) | FE-QI-004-A |
Operational Qualification (OQ)
| Test Type | Test Objective | Equipment | Sheet No. |
|---|---|---|---|
| Particle Concentration | Determine air cleanliness | Particle Counter: AEROTRACK TSI 9350-01 | FE-QO-001-A |
| Airborne Biocontamination | Assess the level of biocontamination in cleanrooms | Airborne Microbial Sampler | FE-QO-002-A |
| Surface Biocontamination | Assess the level of surface biocontamination in cleanrooms | Surface Sampling Applicator | FE-QO-003-A |
| Total Airflow and Air Change Rate | Verification of air velocity and supply airflow | VelociCalc 9565 | FE-QO-004-A |
| Differential Pressure | Verify the facility's ability to maintain the specified differential air pressure between the facility and its surroundings | VelociCalc 9565 | FE-QO-005-A |
| Thermo-Hygrometric Conditions | Verify temperature and humidity conditions at rest | VelociCalc 9565 | FE-QO-006-A |
| Absolute Filter Integrity | Verification of absolute filter integrity | Aerosol Generator: DOP2200-240V-NGB Particle Counter: AEROTRACK TSI 9350-01 |
FE-QO-007-A |
| Decontamination Recovery | Verification of the recovery time to the required cleanliness class | Aerosol Generator: DOP2200-240V-NGB Particle Counter: AEROTRACK TSI 9350-01 |
FE-QO-008-A |
| Airflow Visualization | Verification of proper airflow circulation | Aerosol Generator: DOP2200-240V-NGB Steam Generator |
FE-QO-009-A |
Qualification Protocols: The V-Model Approach to Compliance
To ensure full compliance, the Q2ESB Ingénierie team manages each project using the proven V-Model methodology. For you, this means rigorous validation at every stage: we secure the transition from your initial design concepts to the day-to-day performance of your cleanroom.
DQDesign Qualification
Design Qualification (DQ) is the cornerstone of any cleanroom project. It involves a critical analysis and thorough document review to ensure that the design of your cleanroom and its systems meets the functional requirements (URS - User Requirement Specification), applicable standards, and current regulations. Q2ESB verifies the suitability of architectural plans, airflow diagrams, equipment specifications, and HVAC (Heating, Ventilation, and Air Conditioning) systems before any physical implementation. The objective is to validate that the design is capable of achieving the required performance.
IQInstallation Qualification
Installation Qualification (IQ) is the static verification stage. It confirms that the cleanroom and all its critical components (walls, ceilings, HVAC equipment, HEPA filters, etc.) have been installed in accordance with the plans and specifications approved during the DQ. This phase includes verification of the materials used, connections, initial calibration of measuring instruments, and complete installation documentation. IQ ensures that the environment has been built according to requirements and is ready for functional testing.
OQOperational Qualification
Operational Qualification (OQ) demonstrates that the cleanroom and its equipment operate correctly under simulated or actual operating conditions, but without the presence of product. Dynamic tests are performed to ensure that the expected performance is achieved and that critical parameters (temperature, humidity, differential pressure, and airflow rates) are controlled and stable. OQ validates the acceptable operating ranges and associated alarms, confirming the cleanroom's ability to operate within the specified limits.
PQPerformance Qualification
Performance Qualification (PQ) is the final and most decisive phase. It demonstrates that the cleanroom and its systems operate consistently and reproducibly, delivering the expected results under actual operating conditions, with the products or processes in operation. This stage confirms the environment's ability to maintain the conditions required for product quality over the long term by simulating worst-case scenarios and verifying system robustness. PQ is essential for the release of production batches.
Cleanroom Regulations and Standards
Cleanroom qualification and operation are governed by a strict regulatory framework. Q2ESB Ingénierie operates in accordance with applicable standards and guidelines, including pharmacopoeias and GMP requirements (DQ/IQ/OQ). We carry out all mandatory periodic testing of equipment in controlled environments, including:
- Biological Safety Cabinets (BSCs), fume hoods, laminar flow hoods, safety cabinets for nanostructured products, BIBO systems, isolators, stability chambers, and micro-environments for microelectronics equipment
- Particle contamination, airflow rates, airflow direction and velocity, pressure mapping, tightness and leakage testing, etc.
- Safety parameters, alarms and remote reporting, visual inspections
- A dedicated laboratory and cleanroom for carrying out certain analyses off-site at customer facilities
- A calibrated fleet of more than 20 measurement and analysis instruments covering all qualification parameters
- Core principles: adaptability, responsiveness, mobility, quality, and reliability of measurements and analyses
Skills and Experience
Q2ESB Ingénierie's expertise in cleanroom qualification covers the entire lifecycle of your facilities:
- Compliance with GMP requirements and Pharmacopoeias
- Knowledge of manufacturing processes
- Concept studies, risk assessments, and quality dossiers for regulatory authorities
- Preparation of URS, FDS, Validation Master Plans, FAT and SAT protocols
- Layout studies and workflow optimization
- Clean utilities
- Management and disposal of gaseous, liquid, and solid waste
- Cleaning and decontamination
- DQ/IQ/OQ and PQ qualification with the operator
Our Commitments to a Trusted Partnership
Cleanroom qualification is an essential step in ensuring regulatory compliance and the safety of your critical processes. At Q2ESB Engineering, our approach goes beyond simple technical execution: we build partnerships based on rigor, transparency, and an unwavering commitment to excellence. We understand that every project represents a major challenge for your production or research activities, which is why we are committed to measurable results and a proven methodology. Our philosophy is based on close collaboration, with your specific requirements integrated into every stage of our work.
Technical Expertise and Regulatory Compliance
Strict application of ISO 14644 and NF S 90-351 standards. Our protocols include precise airflow and particle-counting tests, performed using certified and traceable metrology equipment.
Operational Transparency and Responsiveness
Methodical monitoring at every stage, with delivery of a complete documentation package (raw data and test sheets). A dedicated contact ensures a response time of less than 24 business hours.
Long-Term Support and Optimization
Post-qualification support to plan your periodic requalifications and maintain your authorization to operate. Advanced engineering capabilities, including CFD simulation, help anticipate contamination risks.
Your Turnkey Cleanroom Project
For any request related to the qualification or specific assessment of your controlled environments, our engineers structure your project according to the highest industry standards. Entrust us with your requirements to ensure the compliance and performance of your installations.
FAQ — Frequently Asked Questions About Cleanroom Qualification
What does cleanroom qualification mean?
Qualification is a documented process that scientifically demonstrates the compliance of an installation. It confirms that the cleanroom and its associated equipment, particularly the HVAC system, have been designed, built, and installed to operate precisely according to your industrial requirements and applicable regulatory requirements.
What is the difference between qualification and validation?
Although complementary, these two concepts apply to different areas:
- Qualification applies to physical infrastructure and equipment (the cleanroom itself, the air handling unit (AHU), autoclaves, etc.). It confirms that the equipment is technically compliant.
- Validation applies to processes, flows, and methods (a manufacturing procedure, a cleaning cycle, an analytical method). It demonstrates that the final result is safe and reproducible.
Is qualification mandatory for the pharmaceutical industry?
Yes, it is strictly required. Regulatory authorities require critical manufacturing environments to be properly controlled. This requirement is governed by Good Manufacturing Practices (GMP), particularly Annex 1 for sterile products and Annex 15 for qualification criteria, as well as FDA requirements for exports. A complete and approved qualification dossier is an essential prerequisite before starting operations.
Who should prepare and approve qualification protocols (IQ/OQ/PQ)?
The preparation and execution of qualification protocols are generally entrusted to a specialized engineering company experienced in controlled environments. However, under the requirements of GMP Annex 15, final responsibility remains with the client. The Responsible Pharmacist or the site's Quality Director must review, sign, and approve each protocol before testing begins, and subsequently approve the final report after execution. This collaborative approach ensures full transparency of the documentation for regulatory inspectors.
Does a non-conformity detected during particle counting invalidate the qualification?
No. Exceeding a limit or detecting an isolated anomaly does not invalidate the entire process, but it does require a deviation to be opened. Testing must then be suspended so that a root-cause analysis can be conducted, such as checking for filter leakage, insufficient air change rates, or external contamination. Once corrective action has been implemented, the relevant test is repeated. The final qualification report must include the complete history of the deviation and documented evidence of its resolution before approval.
Which regulatory documents are essential for successfully passing a cleanroom qualification audit?
During an inspection (DPM, INS, FDA, or a client audit), auditors require complete traceability. Your qualification dossier should include:
- The Validation Master Plan (VMP) or project compliance matrix.
- The IQ/OQ/PQ protocols, duly approved and signed before testing begins.
- Completed field test sheets with the operators' handwritten signatures.
- All raw data, including particle counter printouts and airflow measurement records.
- Valid calibration and metrology certificates for all measuring instruments used.