Expertise and validation for cleanrooms & operating rooms
Cleanrooms, GMP-critical areas, operating theatres, and laminar flow cabinets are subject to mandatory international regulations such as EU, FDA, ISO 14644, ISO 12469, PIC/S, and GMP Annex 1. These requirements involve performing an initial validation as well as periodic revalidations. Agidens supports you with expert advice, technical support, and the execution of validation tests, ensuring that your facilities remain fully compliant with the applicable standards.
Agidens has a multidisciplinary team of experts specialized in cleanrooms and controlled environments. Our team includes both technical specialists — experts in performing the required qualification tests and verifying the compliance of installations — as well as certified Subject Matter Experts (SMEs). Thanks to this combination of expertise, we are able to offer much more than the technical execution of commissioning, qualification, and validation activities. We provide comprehensive, high-value support to guide you throughout the entire process.
General cleanroom expertise
Agidens has extensive expertise in testing rooms and operating theatres, as well as in testing equipment: isolators, RABS, fume hoods, biosafety cabinets, containment boxes, LAF cabinets, filter boxes, and inline filters…
Commissioning & Qualification
- P&ID verification
- Documentation review
- Contractor / subcontractor oversight
- Component verification
- Functional checks of systems
- Participation in startup tests
- Inspection of room finishes
- Door testing, such as interlocks
- General functionality checks
Validation tests for cleanrooms
- Differential pressure measurements
- HEPA filter integrity testing using a photometer or particle counter (DEHS kit)
- Filter efficiency determination in BSL-2, BSL-3, and animal facility areas
- Air velocity and airflow measurements
- Particle concentration measurements (particle classification)
- Recovery test (recovery time test)
- Microbiological sampling (surface sampling and active and passive air sampling)
- Airflow pattern studies (visualization and recording): smoke studies & smoke tests
- Process validation: smoke studies & smoke tests
- Temperature and relative humidity measurements
- Lighting and sound level measurements
Consultancy assignments
In addition to technical activities, we also support you in areas such as :
- Project follow-up and project management
- Preparation of protocols, plans, and GDP-based documentation
- Process optimization and compliance consulting
Our SMEs are VCCN-certified and have many years of experience in the life sciences industry. With their expertise, they can support you in areas including:
- Risk Based Assessment (RBA)
- Preparation of SOPs, work instructions, and documentation packages
- Root Cause Analysis and RC investigations
- Development and optimization of sampling and measurement plans
- Consulting and guidance for complex compliance challenges
Project process
Reports & Analysis
After performing the tests, the client receives a qualification report containing the conclusions, recommendations, and test data. In case of any deviations, we are happy to work with you to identify possible solutions.
The structure of the validation report is fully aligned with current guidelines. The periodic calibration documentation of our measuring instruments is also included in the validation report.
For conducting the tests, we use calibrated and validated measuring instruments. Based on a mutually approved protocol, we analyze whether the systems meet the acceptance criteria.
Conclusion & Quality Assurance
After the measurements, the final report is reviewed in detail, if desired, in consultation with the responsible departments or suppliers.
In addition to the measurement results, this report also includes recommendations to address any observations or deviations. In this way, inspections and audits are guaranteed to be successful.
CONTACT US FOR MORE INFORMATION
Do you have a challenge related to making your cleanrooms, isolators, LAF cabinets, BSCs, or other controlled environments compliant? Or are you struggling with planning, documentation, or a technical interpretation? Do not hesitate to contact us. Our experts are happy to think along with you.
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Process validation ensures a continuous focus on patient safety, product quality, and data integrity for both manufacturers and consumers. Agidens also supports you in your cleaning activities within laboratory environments and pharmaceutical production facilities, providing guidance and assistance throughout the process.
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The reliability of equipment as well as the accuracy and integrity of analytical results are critical. Our solution-oriented, multidisciplinary consultants provide ongoing support to ensure compliance with applicable regulations.
Thermal Validation
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