Expertise in Cleanroom Support
Cleanroom Support (CLIMB)
At Normec, we ensure that your cleanroom fully complies with cGMP, PICS, and Eudralex regulations. With our unique Cleanroom Implementation Blueprint (CLIMB®), we offer an end-to-end solution — from design to delivery and ongoing support. This results in a cleanroom that not only meets regulatory requirements but also delivers optimal performance for your life science operations.
Your advantages
Rapid deployment
Flexibility within your organisation
Objective view of situations
All our services are ISO 9001-certified.
What is CLIMB®?
CLIMB® is more than just a plan; it’s your roadmap to achieving a fully compliant and efficient cleanroom. It includes:
Design & GMP review: A detailed analysis and optimization of your cleanroom design.
Validation & implementation: From installation to certification, fully aligned with international standards.
Regulations & compliance: Minimal risks through full adherence to relevant regulations.
Operational support: Training and continuous optimization for sustainable and efficient performance.
Cleanroom Validation within CLIMB®
Cleanroom validation is a pivotal component of the CLIMB® process, ensuring that your cleanroom meets all required standards and specifications. Our experts conduct comprehensive tests, including particle counts, microbial sampling, temperature and humidity measurements, airflow assessments, and filter integrity tests, to guarantee optimal functionality and compliance of your cleanroom.
We take full responsibility for the entire validation process, providing you with the assurance that your cleanroom adheres to all necessary requirements and supports safe, sterile production.
Mobile Validation Experts (MoVE)
Through our MoVE division, we offer flexible and rapid validation services utilizing calibrated testing equipment and our extensive expertise. This enables us to perform on-site cleanroom validations swiftly and reliably, allowing you to focus on your business objectives.
CLIMB® – Cleanroom Support Every Step of the Way
Our Cleanroom Implementation Blueprint (CLIMB®) is the key to a successful cleanroom. CLIMB® provides a structured, seamless approach in which cleanroom validation plays a vital role. From design to implementation, and from validation to ongoing operational support, we guide you through the entire process — with a strong focus on compliance with the highest standards.
Explore our CLIMB® roadmap — from process mapping to continuous monitoring
- 1
Processmapping
A crucial first step is mapping all processes in and around your cleanroom, from aseptic work to waste flows and storage. By asking the right questions, we ensure a clear understanding so that we can tailor your cleanroom to your exact needs.
- 2
Design
Normec lays the foundation for efficient cleanroom operations. We start with clear flowcharts that visualise the optimal flow of people and goods. During the design phase, we support you with an independent GMP review and practical advice. When remodeling, we conduct a thorough GAP analysis to identify the adjustments needed for full GMP compliance.
- 3
QRM
As a quality manager, minimising risks is key. Our Quality Risk Management (QRM) supports this throughout the process. Normec brings broad experience in GMP risk analyses, from pharma to hospitals and high-tech start-ups. We provide templates, guidance, or full facilitation to finalise your risk documents.
The ultimate goal is to reduce risk and ensure safety.
Discover more about risk analysis
- 4
URS
At Normec, we ensure a clear User Requirement Specification (URS) from the start. We assist in drafting or managing the document and, if needed, support negotiations with contractors. A solid URS ensures clear tendering and a structured process.
- 5
QMS
Reproducibility is essential in pharmaceutical production. This requires well-documented procedures and clear organisation of documents such as certificates, test results, and validation reports.
Normec supports you in creating, maintaining, and structuring this documentation to ensure you’re always audit-ready. We make sure all necessary SOPs are in place and can perform a GAP analysis of your QMS to identify areas for improvement.
- 6
Commissioning
After the cleanroom is built, proper commissioning is crucial for a smooth transition to the qualification phase. As an independent partner, Normec supports the documentation and execution to ensure everything runs according to plan and delays are avoided.
Discover more about commissioning
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Qualification
To ensure that cleanrooms and systems meet the specifications outlined in the URS, they undergo thorough validation according to the Validation Master Plan (VMP), including IQ, OQ, and PQ. We specialise in drafting, reviewing, and executing qualification documentation tailored to your project. From material checks to testing utilities, software, and equipment, everything is validated according to the defined requirements.
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Validation
Our Mobile Validation Experts (MoVE) bring high-tech equipment directly to your cleanroom to perform all tests as outlined in the protocols. They also validate processes, equipment, and utilities such as sterilization cycles. From document reviews to custom test methods, we provide a complete validation package with protocols, sampling plans, results, and reports.
- 9
Monitoring
Even after cleanroom release, we remain your partner. Ongoing monitoring is essential to ensure lasting quality. Whether it's requalifications, risk analyses, mapping, or internal audits, we provide continuous support and expertise.
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Project Management & Consulting
As cleanroom experts, we also offer full-project coordination. An experienced Project Manager plans, oversees, and delivers your project on time and within budget, working closely with external partners and our in-house experts.
Reach new heights with CLIMB®
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