Suite per camera bianca asettica (doppio modulo) cGMP

The Aseptic Cleanroom Suite (Double Module) cGMP solution has been developed for pharmaceutical manufacturers, biotechnology organisations, CDMOs and advanced therapy providers requiring fully controlled sterile processing environments.

The facility supports aseptic manufacturing processes where environmental control, contamination prevention and validated operational performance are critical. Each suite is designed around process flow, personnel movement and material transfer requirements to support efficient, compliant production operations.

The modular configuration provides a high-performance alternative to traditional construction, enabling organisations to expand sterile manufacturing capacity, support refurbishment projects or introduce new production capability with significantly reduced programme timelines and site disruption.

• Controlled Grade B and C Aseptic cleanrooms house isolators containing the highest level of sterility, Grade A environments
• Supporting Grade C and D cleanroom areas
• Temperature control typically maintained at 20–22°C
• Umidità relativa limitata a 60% RH per evitare la formazione di condensa sulle superfici
• Positive pressure cascade aligned with cGMP requirements
• Dedicated air handling systems with HEPA H14 filtration

Queste suite di camere bianche sono progettate per soddisfare i requisiti di:

• Conforme alle norme GMP dell'UE, inclusi gli aggiornamenti dell'Allegato 1.
• Standard ISO 14644 per camere bianche
• MHRA and FDA aseptic manufacturing guidance
• BS EN cleanroom construction standards
• Normative COSHH

The facility is designed to accommodate critical aseptic processing equipment, including isolators, cleanroom furniture and process support systems.

Supporting areas such as preparation zones, QA spaces, storage and sterilisation facilities can be integrated within the host building to ensure efficient workflow and compliance.

Every facility is delivered with full commissioning and validation, including:

• HEPA filter integrity testing
• Airflow visualisation and air change verification
• Particle counting and environmental monitoring
• Temperature and humidity testing
• Cleanroom recovery testing
• Comprehensive documentation is provided, including DQ, IQ and OQ protocols, ensuring full audit readiness from day one

Trovare una soluzione adatta alla tua organizzazione nel settore delle scienze della vita inizia qui.