CGMP Cleanrooms

CGMP cleanroom compliance designates six components: quality, production, laboratory, materials, facility equipment, and package labeling. Aseptic cleanroom workflows must accommodate for each criterion with clean air, monitoring systems, sterilization process validation, and ergonomic workflow.

Pre-existing structures, state board oversight, and compliant equipment outfitting require experienced cleanroom engineers. Component sourcing, budget, facility size, auxiliary space, future proofing - these all affect how experts tackle operational temperature, humidity, HVAC, and particle control.

Any rogue contamination requires exhaustive process overviews, protocol reviews, and operator interviews. Without acute preliminary engineering, variables are maddening and production suffers. Our customers know that improperly designed control systems result in unnecessary contamination, mix-ups, and even recalls.

A CleanPro® system emphasizes data generated under operation-ready conditions. Design and installation are acutely engineered so that your system validates within established ISO Class limits and FDA guidelines. Because we pre-engineer each cleanroom for specific compliance and application, we can guarantee that our CGMP cleanrooms meet your state, federal, and organization benchmarks. Our customers rest easy because they know we've tested process parameters and function throughout an operation sequence and also during fault and failure conditions.

Cleanroom Classifications for Common GMP Applications

The CleanPro® Advantage

Cleanroom construction, much like building a new facility, requires a myriad of workers, parts, materials, and design considerations. Sourcing components and supervising construction for a new facility is not something you'd ever take on by yourself. Why would building a cleanroom be any different?

Cleanroom control systems and electrical designs are critical, but so are considerations for structural, architectural, and application compliance. Turnkey cleanroom solutions with modular components empower easy adaptation of adjacent structures, cascaded classification of interior rooms, expandable compliance, and relocation. By coordinating an expansive network of contractors, vendors, and compliance experts, CleanPro® turnkey cleanroom service consolidates cleanroom planning, design, engineering, construction, assembly, and certification into a single point of contact.

ISO 9001:2015 Certified

ISO 9001:2015 is an internationally recognized standard for Quality Management Systems (QMS). It is designed to provide companies with a set of principles that ensure a systematic approach to achieving customer satisfaction.

CleanPro® a division of Production Automation corporation, has implemented procedures to ensure a consistent standard of service for our customers, and customer feedback monitoring to uphold expectations between our vendors, warehouses, and the end-user. We continually conduct internal reviews to ensure that we are always improving.

Get Cleanroom Design Help at No Cost

Understanding the right CGMP cleanroom solution requires asking the right questions. Submit your contact information below to get in touch with a cleanroom expert.