Expert Services

Facility Designing

Comprehensive & Compliant Facility Design Solutions

At AQC, we specialize in providing state-of-the-art facility design services tailored for medical device manufacturers. Our expert team ensures that your facility meets national and international regulatory standards, optimizing efficiency, compliance, and operational excellence.

Our Facility Design Expertise

Medical Device Manufacturing Facilities (Sterile & Non-Sterile)

We design and develop manufacturing facilities that meet regulatory standards for both sterile and non-sterile medical devices, ensuring compliance with:

  • FDA & ISO 13485 Requirements
  • EU MDR & GMP Guidelines
  • Risk-Based Approach to Facility Layout & Workflow

Cleanroom Design & Compliance

We create high-performance cleanroom environments that adhere to industry-specific cleanliness and contamination control requirements:

  • ISO 14644 Cleanroom Classification Compliance
  • HEPA/ULPA Filtration & Airflow Control
  • Environmental Monitoring System Design

HVAC System Design & Optimization

Ensuring a controlled environment with precision-engineered HVAC systems:

  • Temperature, Humidity & Pressure Control
  • Airflow & Filtration Strategy for Cleanrooms
  • Energy-Efficient & Compliant System Design

Water System Design

We design water purification and distribution systems that comply with industry standards:

  • Purified Water (PW), Water for Injection (WFI), & Reverse Osmosis (RO) Systems
  • Compliance with USP, EP, & WHO Guidelines
  • Microbial & Chemical Contamination Control

Compressed Air Systems

AQC provides reliable and compliant compressed air system designs for medical device manufacturing:

  • ISO 8573 Air Quality Standards Compliance
  • Oil-Free & Dry Air Systems for Critical Applications
  • Monitoring & Filtration Strategies

Laboratory Equipment & Instrument Design

We assist in planning and integrating laboratory setups for medical device R&D and quality control:

  • Biosafety & Cleanroom-Compatible Lab Designs
  • Ergonomic & Workflow-Optimized Layouts
  • Equipment Placement for Maximum Efficiency

Production Equipment Layout & Integration

AQC ensures optimal space utilization and seamless workflow for production facilities:

  • Equipment Selection & Validation Support
  • Lean Manufacturing & GMP-Compliant Layouts
  • Process Flow Optimization & Scalability Considerations
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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