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Aseptisk renrumssvit (dubbelmodul) cGMP

Översikt

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.

Viktiga funktioner

  • 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
  • Relativ luftfuktighet begränsad till 60% RH för att förhindra kondensbildning på ytor
  • Positive pressure cascade aligned with cGMP requirements
  • Dedicated air handling systems with HEPA H14 filtration

Built for compliance

Dessa renrumssviter är utformade för att uppfylla kraven för:

  • Uppfyller EU GMP-kraven inklusive uppdateringar av bilaga 1
  • ISO 14644 renrumsstandarder
  • MHRA and FDA aseptic manufacturing guidance
  • BS EN cleanroom construction standards
  • COSHH-föreskrifter

Integrerad utrustning och arbetsflöde

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.

Validation-ready by design

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

Att hitta en lösning som fungerar för din life science-organisation börjar här

Komma i kontakt

Vanguard Livsvetenskap
Unit 1144 Regent Court, The Square, Gloucester Business Park, Gloucester, GL3 4AD

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