cGMP Facility Design
AssureImmune has decades of experience in designing and managing Current Good Manufacturing Practices (cGMP)-compliant clean room facilities. Our team assists you in cGMP manufacturing facility design, development and registration.
AssureImmune cGMP facility design services include:
- Manufacturing, Segregation, Ancillary Space Design & Validation Facilitation
- Critical Equipment Design Validation Planning
- Personnel Flow Design
- Process Flow Design
- Waste Systems & Storage Needs Consulting
- Validation & Regulatory Compliance Oversight
- HVAC Verification
- Clean room validation
- Environmental Monitoring Plan & Data Review Development
Reference:
1. Khan A, Longsomboon B., Hare J.M. (2022) Design of a Multiuse Academic GMP Facility at University of Miami. In: Gee A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_17. First Online: 11 November 2021.