Facilities Design or Validation

Lachman Consultants is skilled in assisting organizations as they encounter facilities design, construction, or adaptation—or as they encounter facilities-related compliance problems.

Through a powerful blend of compliance, regulatory, scientific, and technical expertise, Lachman is highly effective in:

  • Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
  • Developing environmental and processing-room requirements
  • Recommending effective flow of materials, equipment, and personnel
  • Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
  • Addressing the facilities requirements of laboratory operations
  • Performing factory acceptance testing of equipment (FAT)
  • Conducting audits during construction and installation phases
  • Qualifying facilities for sterile, low-bioburden, and non-sterile products
  • Qualifying facilities for intermediates, APIs, and finished drug products
  • Qualifying facilities for medical device components and finished products