top of page
StanInfra-logo

Medical Device
Cleanroom Solutions

Medical device Cleanroom Design, Construction & Controlled Environment Solutions

Deep technical expertise in ISO 14644 cleanroom classification and GMP regulatory standards. Stan Infra delivers high-precision HVAC and MEP systems integrated with advanced filtration and pressure balancing architecture for specialized medical device manufacturing environments.

MEP_edited.jpg

Industry Challenges

Manufacturing medical devices requires absolute control over atmospheric variables. We address the critical hurdles that threaten product integrity and regulatory approval.

Contamination Risks

Particles, microbes, and chemical vapors can lead to batch failures and compromised device safety. Our designs include redundant filtration and strict pressure zoning.

Regulatory Complexity

Navigating ISO 14644, ISO 13485, and GMP requirements is a major hurdle. We build documented compliance into every stage from architecture to commissioning.

Environmental Stability

Sensitive medical components require precise temperature and humidity ranges. Our high-performance HVAC systems ensure +/- 1°C stability 24/7/365.

Our Engineering Approach

Design & Planning
  • Cleanroom layout & material flow
  • HVAC system capacity modeling
  • Pressure cascade mapping
  • Compliance risk assessment
Implementation
  • Turnkey MEP installation
  • High-performance ductwork
  • Air handling units (AHU)
  • Modular cleanroom partitions
Lifecycle Services
  • Commissioning & IQ/OQ
  • ISO particle count validation
  • Regulatory walkthrough support
  • Annual maintenance contracts

Typical Systems Delivered

  • Class 100 to Class 100,000 Cleanrooms
  • HEPA/ULPA Filtration Systems
  • Laminar Airflow Units
  • Pass-Through Boxes & Air Showers
  • Environmental Control Systems (ECS)
  • Static Control (ESD) Flooring
  • Compressed Air & Process Gases
  • Energy-Efficient AHU Systems

Regulatory & Technical Requirements

01

ISO 14644-1 Cleanroom Classifications (Class 5 to 8)

02

Compliance with ISO 13485 Quality Management Systems

03

Strict Adherence to EU GMP and US FDA Guidelines

04

Full IQ/OQ/PQ Qualification and System Validation

01 / 06
This is the area to introduce viewers to the context of this image. Briefly explain what it represents, why it matters, and how it aligns with the theme of your gallery.

Build Your Medical Manufacturing Cleanroom

  • Turnkey ISO & GMP Compliance
  • High-Precision HVAC & MEP Systems
  • Advanced Pressure Balancing Architecture
  • ISO 13485 Standards Integration
  • Continuous Performance Monitoring
  • Rapid-Response Maintenance & Support
bottom of page