Biocoat Life Sciences ISO 7 Modular Cleanroom

Biocoat needed an ISO 7 cleanroom for a new manufacturing process and equipment. The supplied project record says Reynolds coordinated design through demolition, renovation, and installation, including the modular cleanroom and adjoining office, HVAC, electrical, sprinklers, and custom flooring.

ISO 7 is an airborne-particle cleanliness class defined by ISO 14644-1. It describes particle concentrations at specified sizes under an agreed occupancy state. It does not, by itself, define a product's regulatory status, operating procedures, validation program, or every environmental control.

No. ISO 7 addresses airborne-particle cleanliness. FDA compliance depends on the regulations that apply to the product and operation, the manufacturer's quality system and processes, verification or validation where required, and supporting documentation. For medical devices, FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference.

Document the process and equipment, required classification and occupancy state, people and material flow, temperature, humidity and pressure requirements, utilities, cleaning approach, applicable quality-system requirements, and who owns testing and acceptance. Those inputs give the project team a defined basis for room and supporting-system design.

Classification compares airborne-particle concentrations with the selected ISO class. Qualification or acceptance uses agreed tests to determine whether specified room and system requirements are met. Ongoing monitoring is the continuing plan for observing performance; ISO 14644-2 addresses monitoring related to airborne-particle cleanliness.

Responsibilities should be assigned in the project requirements. The owner, quality team, design and construction team, and testing provider may have different roles. Reynolds' Biocoat record supports a coordinated construction scope; it is not evidence that Reynolds alone performed regulatory certification or product-process validation.