USP 800 Cleanroom Design – Negative Pressure Changes and Requirements
What equipment and engineering controls do USP 800 cleanrooms require? What types of storage and monitoring systems will I need?
What equipment and engineering controls do USP 800 cleanrooms require? What types of storage and monitoring systems will I need?
A gowning room has many variables. There is no mathematical formula when determining the features, surfaces, and HVAC requirements best suited for your application. Space requirements, volume of operators, aseptic workflows, material choice, and even aesthetics all factor into design considerations. Most facilities benefit from contacting a controlled environment specialist who can identify critical product sensitivities, storage requirements, and operational standards.
For communication satellites that remain within earth’s orbit, an ISO Class 6-8 cleanroom allows sufficient particle and contaminant control. Cleanroom engineers design each space so that particles from production surfaces are whisked away from critical components. A combination of softwall production areas and hardwall cleanroom facilities provide isolation of critical tasks.
Pre-engineered fabrication consolidates scheduling with minimal disruption and fewer variables. Difficult or expensive upgrades avoid overbearing noise, construction artifacts, and minimize if not eliminate the burden on facility staff for project management.
New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.
Definitive Cleanroom Construction FAQ: How much does a cleanroom cost? How does the level of ISO classification impact build and operating costs? How much supporting space will I need for a cleanroom addition or ISO class upgrade? What’s the advantage of a turnkey cleanroom system?
Modular construction delivers countless enterprise cleanrooms faster, with tighter performance specifications than traditional builds. Modular cleanrooms reduce architectural and engineering planning by standardizing prefabricated walls, ceilings, and features.
Turn-key systems provide a production ready environment with a fractional build time of traditional construction. Our cleanroom specialists help you identify which components best suit for your application with respect to federal and organizational guidelines.
Softwall cleanrooms isolate clean processes, or insulate dirty ones. Medical device manufacturing, pharmaceuticals, high particulate processes, paint, automotive, packaging, or injection molding: each application is dynamic with unlimited variables.