Cleanrooms for Medical Devices

Cleanrooms for Medical Devices

Ziebaq designs, engineers, and delivers advanced cleanroom environments specifically tailored for the manufacturing and assembly of medical devices. Our modular cleanroom systems support ISO 8, ISO 7, and ISO 5 classifications, creating controlled, compliant, and high-performance spaces for every stage of medical device production

Features of Ziebaq Cleanrooms for Medical Devices

Every process—from component preparation and assembly to testing and packaging—requires stringent contamination control. Ziebaq’s modular cleanroom solutions offer exceptional safety, regulatory compliance, and long-term reliability for medical device manufacturers.

Our cleanrooms integrate advanced HVAC technology, high-efficiency filtration, and sterilisation-friendly materials to ensure consistent environmental stability. Smooth, flush finishes make cleaning effortless, supporting operational productivity and audit readiness.

For electromedical devices, Ziebaq incorporates specialised surface finishes, antistatic worktops, and removable wall systems that simplify equipment transfer and accommodate large-format machinery.

Key Advantages

• High mechanical resistance for long-term operational stability and robust structural performance.
• Chemical-resistant surfaces that withstand aggressive cleaning and sterilisation agents.
• Superior airtightness to maintain controlled environments during critical operations.
• Zero particle retention and no microbial proliferation—crucial after sterilisation and during aseptic handling.
• Certified materials compliant with international standards for cleanroom walls, ceilings, and electrical installations.
• cGMP-aligned consulting, ensuring every facility meets global regulatory expectations.

ISO 14644 Cleanroom Environments for Medical Devices

ISO 14644 is the internationally accepted framework governing the classification, design, operation, and continuous monitoring of cleanrooms. For medical device manufacturers, compliance is essential for ensuring product safety, meeting global regulations, and maintaining consistent contamination control.

Understanding ISO 14644

ISO 14644-1 classifies cleanrooms from ISO Class 1 (most stringent) to ISO Class 9 (least stringent), based on allowable airborne particle concentrations. This measurable, data-driven system defines cleanliness levels required for highly sensitive medical device production.

Compliance with ISO 14644 enables manufacturers to demonstrate objective control over environmental conditions, supporting audits, regulatory reviews, and long-term quality assurance programmes.

Path to Certification

Achieving ISO 14644 compliance requires rigorous validation of:

• Airflow velocity and uniformity
• Filtration performance (HEPA / ULPA integrity testing)
• Pressure differentials
• Temperature and humidity stability
• Airborne particle levels via calibrated particle counters

Particle counting is a core component of cleanroom classification. Precision counters measure concentrations as low as 0.1 μm, with results analysed using standardised sampling procedures.

Validation and re-qualification follow the methodologies defined in ISO 14644-3, while ongoing monitoring and periodic re-classification follow ISO 14644-2.

Design, Operation & Lifecycle Compliance

ISO 14644-4 and ISO 14644-5 outline critical guidelines for:

• Cleanroom architectural design
• Material selection
• Air handling and pressurisation
• Personnel protocols and gowning
• Equipment movement and cleaning procedures

The broader ISO 14644 series covers the entire cleanroom lifecycle—from conceptual design through construction, operation, monitoring, and eventual decommissioning—ensuring facilities remain compliant, safe, and production-ready at all times.

Turnkey Solutions for Cleanrooms and Production Facilities

Ziebaq delivers comprehensive turnkey solutions for cleanrooms, controlled environments, and production facilities—positioning itself as a single, reliable point of contact for the entire lifecycle of your project. From engineering and manufacturing to installation, integration, and qualification, Ziebaq ensures a seamless experience and optimised facility performance.

Our end-to-end approach simplifies project execution, reduces installation timelines, and ensures every cleanroom and production system meets the highest standards of safety, compliance, and operational efficiency.

Seismic-Certified Cleanrooms

Ziebaq cleanrooms are engineered for uncompromising safety, even under extreme seismic conditions. Ziebaq offers advanced seismic-resilient cleanroom systems designed and tested to international standards, ensuring structural integrity, personnel protection, and uninterrupted operations.

These systems are built to withstand major seismic events without damage to equipment, infrastructure, or the controlled environment—eliminating restoration costs and preserving production continuity when it matters most.

Modular Building Meets Modular Cleanroom Systems

Ziebaq’s modular construction technologies combine speed, scalability, and sustainability to support modern medical, pharmaceutical, and high-precision manufacturing facilities. Our modular solutions offer flexible configurations that accelerate project timelines while maintaining strict regulatory and engineering standards.

Ziebaq provides a complete suite of modular cleanroom building options, including:

• Prefabricated Modular Structures for fast deployment
• Container-Based Modular Solutions for compact or remote installations
• Custom Modular Units designed using advanced hybrid systems for high-performance production environments

Each solution integrates seamlessly with Ziebaq cleanrooms, HVAC technologies, and partitioning systems—creating a cohesive, efficient, and future-ready facility.

Ziebaq Mangini is transforming the cleanroom experience with a design philosophy that prioritises operator well-being, comfort, and efficiency. In industries where precision and contamination control are critical, the human element often gets overlooked. Our human-centered cleanroom solutions bridge this gap by creating environments where people can perform at their best while maintaining the highest standards of cleanliness and safety.

Traditional cleanrooms are typically cold, rigid, and mentally exhausting, leading to operator fatigue, stress, and decreased motivation over time. Recognising these challenges, Ziebaq Mangini has reimagined the cleanroom environment through ergonomic layouts, superior materials, optimised airflow systems, and comfort-enhancing design elements.

By incorporating thoughtful features that reduce physical strain and create a more welcoming atmosphere, we enable companies to foster a motivated workforce, enhance productivity, and strengthen operational reliability. This human-centered approach not only benefits employees but also directly improves process consistency, safety outcomes, and overall performance.