Cleanroom Design and Construction: Our Process

User requirements (quoted/specified solutions and products) are drafted into a ‘Basis of Design’ (BOD) document. A completed Client specification, URS, or Client approval of the BOD is REQUIRED prior to progression into full scale design and engineering works which occurs in Phases 2 & 3. The BOD serves to finalize and define client requirements into a detailed set of instructions to be utilized for the design, engineering and later construction of a solution or facility that satisfies client requirements.

Following customer approval of the BOD, Germfree will prepare Schematic Design drawings and layouts illustrating conceptual layouts and workflow as agreed within the BOD. This includes spatial relationships, equipment layout, room cards and personnel/material flow. Also, in-depth research into jurisdictional regulations and requirements is completed during the SD phase. Deliverables from the SD phase include layouts and drawings of a site plan (if applicable), floor plans, elevations and spatial relationships. Upon SD approval and Design Freeze, some long lead items and materials may be released to procurement.

The DD phase produces both 2D & 3D drawings and renderings. P&ID’s, load calculations, diagrams, plans and detailed schematics are engineered. The DD package is submitted to the client for approval prior to the commencement of full-scale production and release of all items to procurement.

The fabrication design phase which focuses on design for fabrication. This phase is one of the most critical phases of a project. Engineers interpret the detailed design into drawings that drive the actual build and install of the facility itself.

The manufacturing team at Germfree Laboratories is composed of a diverse group of professionals that use their expert experience to build our complex facilities. Our team ensures that the facilities meet all necessary structural, electrical, and mechanical requirements.

We use innovative technologies and methods to monitor your project at every step. We also offer customizable quality control solutions that can be tailored to meet the specific needs of each client, ensuring that their products meet the highest standards of quality and compliance.

We document and record the rigging and shipping process of each mod, including verification of dunnage placement and fitment of the load onto each truck. Our completed modules can weigh 40,000 pounds when fully equipped.

Prior to delivery of your project, Germfree will work with you to determine what site work needs to be completed before installation can occur.

Our team will create a suite of documents that can be used by the client to provide objective evidence to a regulatory body (CDC, FDA, etc) that the facility or equipment was built and operates as designed and meets the client User Requirements Specification (URS). These documents include a commissioning plan, FAT/SAT protocols, and a summary report.

Covering the globe, Our 24/7 service team travels the globe maintaining facilities and equipment that have been in operation for many years. From Asia to the Middle East to right here in the USA, Germfree’s Service team is dedicated to making sure that your Germfree products continue to provide you with the best performance possible by performing preventative maintenance and full service support.