Reinraum-Suite (Doppelmodul) für Advanced Therapeutics cGMP

The Clean Containment Suite (Double Module) has been developed specifically for organisations operating within advanced therapies and high-value biologics manufacturing.

The facility provides controlled Grade A processing environments within isolators, supported by surrounding Grade B and Grade C cleanroom areas. Environmental controls and containment strategies work together to maintain process integrity while protecting products, operators and surrounding environments.

• Designed for gene therapy and ATMP manufacturing
• Grade C processing with controlled containment
• Positive pressure cascades supporting clean-to-less-clean flow
• Dedicated HVAC systems with HEPA H14 filtration
• Environmental monitoring with BMS integration
• Temperature control
• Die relative Luftfeuchtigkeit ist auf 601 % RH begrenzt, um die Bildung von Kondenswasser auf den Oberflächen zu verhindern.

Diese Reinraumsuiten sind so konzipiert, dass sie die Anforderungen folgender Bereiche erfüllen:

• EU-GMP-konform einschließlich Aktualisierungen in Anhang 1
• ISO 14644 Reinraumstandards
• MHRA and FDA guidance
• COSHH and BS EN construction standards
• COSHH-Vorschriften

The clean containment suite supports key process equipment including isolators, incubators and cleanroom-compatible furniture, enabling efficient and compliant workflows.

Additional supporting areas such as staging, QA, storage and waste handling can be incorporated within the wider facility.

Each facility undergoes full commissioning and validation, including:

• HEPA integrity testing and airflow verification
• Air change rate testing
• Pressure cascade and room integrity testing
• Environmental monitoring system validation
• Particle counting and cleanroom recovery testing
• All documentation is provided to support regulatory compliance and inspection readiness

Die Suche nach einer passenden Lösung für Ihr Life-Sciences-Unternehmen beginnt hier