Expertise in Cleanroom Support

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.

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.

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.

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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.

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.

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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.

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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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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.

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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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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.