Delivering a compliant cleanroom
Implementing a cleanroom is a complex process that brings together design, regulatory requirements, validation and operational processes. A mistake at any stage can lead to delays, additional costs or compliance risks.
With CLIMB® (Cleanroom Implementation Blueprint), Normec provides a structured approach to designing, building, qualifying, validating and maintaining cleanrooms. You benefit from a single partner who supports you throughout the entire project lifecycle.
From design to operational support
CLIMB® has been developed to support organisations in the life sciences sector at every stage of a cleanroom project. Our goal is to help you create a compliant, efficient and future-ready cleanroom.
Through CLIMB®, we provide support with:
- Cleanroom design and GMP review
- Validation and implementation
- Regulatory compliance
- Training and operational support
- Project management and consultancy
This integrated approach ensures that every phase of the project fits seamlessly together.
One roadmap for a compliant cleanroom
CLIMB® is built around a proven roadmap that covers every critical aspect of a cleanroom project.
With CLIMB®, you can:
- Reduce risks during design, construction and commissioning
- Demonstrate compliance with applicable GMP requirements
- Follow one structured project approach from start to finish
- Benefit from specialist expertise at every stage of the project
- Build a strong foundation for safe and reliable manufacturing
The roadmap includes process analysis, design, risk assessments, User Requirements Specifications (URS), quality management, commissioning, qualification, validation, monitoring and project management. This creates a fully controlled process from concept through to an operational cleanroom.
Cleanroom validation as part of CLIMB®
Validation is a critical stage of every cleanroom implementation project. Normec performs the required testing to verify that your cleanroom meets all specified requirements and performs as intended.
Our specialists carry out:
- Particle counting
- Microbiological sampling
- Temperature measurements
- Humidity measurements
- Airflow measurements
- Filter integrity testing
We also support the qualification of cleanrooms, systems, equipment and processes in accordance with your Validation Master Plan (VMP), including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Mobile Validation Experts
Our Mobile Validation Experts (MoVE) perform on-site validation using calibrated equipment and specialised measuring instruments.
In addition to cleanroom validation, our experts support the validation of processes, equipment and utilities. We provide complete validation documentation, including protocols, test results and comprehensive reports.
Our support continues after your cleanroom becomes operational. Through monitoring, requalification, risk assessments and audits, we help ensure your cleanroom remains compliant and performs at the highest level.
Climb to success with CLIMB®
CLIMB® provides a proven methodology for managing the complexity of cleanroom projects. By combining design, regulatory compliance, validation and operational support within one integrated approach, Normec helps you deliver a successful cleanroom faster, more efficiently and with reduced risk.
Would you like to know more about cleanroom implementation and validation?
Frequently Asked Questions
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CLIMB® stands for Cleanroom Implementation Blueprint. It is Normec's structured methodology for designing, building, qualifying, validating and maintaining cleanrooms.
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CLIMB® is designed for organisations in the life sciences sector, including pharmaceutical companies, biotechnology organisations, hospitals and medical device manufacturers.
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Normec supports cleanroom projects in accordance with cGMP, PIC/S and EudraLex requirements.
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Our services include particle counting, microbiological sampling, airflow measurements, temperature measurements, humidity measurements and filter integrity testing.
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Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are qualification stages that demonstrate systems have been installed correctly, operate as intended and consistently perform according to predefined requirements.
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Normec's Mobile Validation Experts (MoVE) perform on-site validation using calibrated equipment and specialised measuring instruments.
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Yes. We continue to support organisations with monitoring, requalification, risk assessments and audits to maintain cleanroom performance and regulatory compliance.