Ghonaym Biotech and Engineering of Houston LLC
Regulatory compliance for cleanrooms involves adhering to ISO 14644 air cleanliness standards and national regulations such as FDA cGMP (21 CFR Parts 210/211) and EU GMP Annex 1. Key elements include environmental monitoring, controlled airflow with HEPA filtration, gowning protocols, SOPs, training, and complete documentation to ensure product quality and safety.
Sitewide PMs and control tuning drove reduced downtime and stable environmental performance.
Office renovation with electrical and life-safety upgrades; phased execution to minimize disruption.
Delivering precision-engineered HVAC systems aligned with ASHRAE standards and GMP best practices for pharmaceutical, industrial, and commercial environments.