Quality Engineered Structures Basis of Design Image 1

Cleanroom Basis of Design
cGMP Layout, Pre-construction Design Review, Validation, Commissioning, Onsite Inspection

Quality Engineered Structures Basis of Design Image 2 Appropriately designed and engineered cleanrooms start with collaboration between our design team and the clients in house process engineers. All design and engineering is based on equipment process, process flow and process heat load requirements. Standards and specifications governing the process must be exactly known. The goal of the basis of design is to arrive at a full set of specifications for all process functions to determine the preliminary cleanroom design documentation.

The following items should be compiled in an accurate manner and validated by the cleanroom design team and in house process engineering staff prior the design phase of the project. Completing and adhering to a basis of design(BOD)is the only known way to mitigate severe issues during the validation and commissioning phase.

Basis of Design:

  • Classification Requirement and Regulatory Authority for process, procedures, and jurisdictional venues for which the process and facility will need to be validated.
  • Complete Process Descriptions with process flow diagrams.
  • cGMP Floor Plan with process equipment layout identified to attached process equipment specification descriptions.
  • Process Equipment Specification List with complete descriptions of utility requirements, dimensions, and  weight.
  • Process Support Service Utilities List with complete descriptions of voltage, amperages, volumes, and exhaust cfm required.
  • Flow Diagrams of people, product, and materials required by functions.
  • HVAC Zoning Floor Plan with complete descriptions of room classification, pressure differentials, and microbial limits.
  • Realistic Budget Specifications on equipment and cleanroom construction.
  • Realistic Project Schedule with time allowances for equipment and construction material lead time, construction time, and validation requirements.
  • Engineers Information sheet should include all contact information for all engineers or operators involved in the Basis of Design formulation.
  • Local Code Compliance to all mechanical, electrical, plumbing, structural(MEPS), fire and environmental codes.

A successful cleanroom operation will only happen if all information input is factual of the requirements. Completing an accurate basis of design while in the preconstruction phase will mitigate errors or omissions during the actual construction phase. Manufacturers material safety data sheets(MSDS) and equipment specification sheets should be specific to the model or material being utilized.

Validating and commissioning cleanroom environments involves ensuring that the cleanroom systems are designed, installed, calibrated, and perform to the owners project requirements. Commissioning and validation should start in the design phase and continue through the installation of process and equipment components installed during the actual construction phase. A final commissioning phase should be completed during the start up and testing phase of the cleanroom construction. Regulatory agencies will request this documentation during on site inspections. A strong basis of design will mitigate errors and omissions that can lead to the expensive process of correcting or replacing components that were engineered to an incorrect process specification.

Inspections by municipal inspectors required by the construction permit are not performed to meet any regulatory agencies requirement for cleanroom commissioning.  They should be complemented by onsite or threshold inspections by the mechanical, electrical, structural, and environmental engineers having designed the systems to assure that the installation subcontractors are performing to the construction drawings, documentation, and specifications. Design engineers should be present for all testing, balancing, and air particle certification test performed during the final commissioning phase. Inspection reports should be logged and organized into a project commissioning binder by date and engineering discipline.

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