Lab design and process

Lab design and process

Designing a molecular diagnostic lab involves carefully planning and consideration of various technical, regulatory, and operational factors to ensure functionality, efficiency, and compliance with quality standards.

At ClueGenix, we are speacialized in providing the following services -

  1. Space Requirements: Determine the space needed based on the types and volume of tests to be performed, equipment specifications, workflow considerations, and safety requirements (e.g., biosafety levels).

  2. Workflow Optimization: Design workflows that minimize cross-contamination risks and optimize the efficiency of sample processing, testing, and result reporting.

  3. Equipment Selection: Based on throughput needs, test complexity, and budget constraints, choose appropriate equipment such as PCR machines, sequencing platforms, and automated sample handling systems.

  4. Laboratory Safety: Ensure compliance with biosafety regulations (e.g., containment levels for handling infectious agents) and design features that promote safe working practices and minimize exposure risks.

  5. Environmental Controls: Implement systems for temperature and humidity control, ventilation, and air quality to maintain the stability and integrity of reagents and samples.

  6. Utility Requirements: Plan for electrical power, water supply, waste disposal systems, and emergency backup systems to support uninterrupted laboratory operations.

  7. Ergonomics: Design workspaces, benches, and equipment layouts to optimize ergonomic conditions for laboratory staff, considering factors such as comfort, safety, and efficiency.

  8. Regulatory Compliance: Ensure adherence to local and international regulatory standards (e.g., ISO 15189, CLIA in the US, NABL in India) governing laboratory design, operations, and safety.

Stepwise Services Offered by ClueGenix  for developing a new lab/department -

  1. Initial Consultation and Assessment: Evaluate client needs, project scope, regulatory requirements, and budget constraints.

  2. Conceptual Design: Develop preliminary designs and layouts based on functional requirements, workflow analysis, and regulatory compliance.

  3. Detailed Design: Create detailed architectural drawings, specifications for equipment and systems, and technical documentation required for construction and regulatory approvals.

  4. Project Management: Oversee project implementation, including construction coordination, equipment installation, and commissioning to ensure adherence to design specifications and timelines.

  5. Validation and Accreditation Support: Assist with validation protocols, quality assurance procedures, and preparation for accreditation inspections to ensure compliance with regulatory requirements.

  6. Post-Occupancy Support: Provide ongoing support for troubleshooting, equipment maintenance planning, and optimization of lab operations after commissioning.