Sterile production, filling, compounding and packaging must follow GMP. We translate EudraLex Volume 4 and Annex 1 into cleanrooms that are ready for inspection.
Cell & gene therapyMedical devicesPharmaceutical manufacturingRadiopharmaceuticals
Annex 1 is the key guideline for sterile facilities. Its update requires a documented, risk-based contamination control strategy. We guide you through it, from gap analysis to a CCS that holds up in an inspection.
Revised EU GMP Annex 1: Manufacture of Sterile Medicinal Products
Engineer-to-Order projects carry design risk and validation complexity. Pre-engineered, validated ADAPTUS components give you control before installation starts.
The design meets regulatory and process requirements, built from pre-validated ADAPTUS components.
Installation matches the approved design. Standard CTO components speed up on-site verification.
Systems operate within defined parameters, using pre-tested systems.
Consistent, repeatable operation in a controlled state, supported by the CTO architecture.
A CCS consolidates all contamination controls in one plan, backed by risk assessments and scientific evidence. CTO designs avoid the typical failure points of custom builds. Non-intrusive maintenance, for instance, allows servicing from non-classified areas and limits technician entry.
We assess your current practices against Annex 1.
We develop a contamination control strategy you can operate and defend.
From design to installation and long-term support: cGMP compliance, environmental monitoring and full validation, for new facilities and upgrades.
Pre-engineered building blocks, circular design, validation, GMP monitoring, commissioning or remodelling: our team answers quickly and to the point.
