Cleanrooms for Medical Devices

Cleanrooms for Medical Devices by Ziebaq provide ISO-classified, contamination-controlled environments specifically designed for medical device manufacturing and assembly. With advanced HEPA filtration, regulated airflow, particle control, and strict environmental monitoring, they ensure product sterility, quality, and compliance with global regulatory standards throughout production and packaging processes.

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Medical Devices & Diagnostics Cleanrooms

Medical device cleanrooms are not optionals as they act as a defence against microbes and particles which could turn life-saving implants into liabilities. For devices that are inserted into the body like catheters, pacemakers, etc, even a smallest particle can be life threatening. This is why diagnostics cleanrooms ensure PCR tests or blood analysers give accurate results. 

Design Features That Gives Flawless Performance

Zeibaq offers high tech and quality nutraceuticals cleanrooms. These cleanrooms have integrated walls that defend against chemical assaults, smooth FRP, aluminium panels, heat-welded vinyl floods. All these features help cut down cleaning downtime to half and decrease labour costs significantly. 

Real-World Application Of Medical Device Cleanrooms

From stent crimping to syringe filling, medical device cleanrooms are designed for it all. Medical implants require ISO 5 rigor because even a tiny particle can cause rejection. Cleanrooms are also used in PCR labs or kit packaging because even minor humidity levels can impact the final product. Other wearable medical devices such as glucose monitors are also assembled in these cleanrooms as it ensures maximum sterility. 

Zeibaq Cleanrooms: Your Scalable Path To Dominance

Medical device cleanrooms manufactured by Zeibaq adhere to FDA's Good Manufacturing practices (GMP) and ISO 13485. With seamless epoxy floors, cleanrooms designed by us offer 100% protection against particles that can impact the quality of medical devices. 

Factors To Keep In Mind When Planning & Using A Controlled Environment

  • Proper clothes and dressing anteroom

  • Controlled use of and entry into controlled areas
  • Eating, drinking, smoking or chewing gum banned inside cleanroom
  • Prevent use of lead pencils
  • Regulate storage of glassware & containers
  • Room's air quality must be maintained
  • Ensure cleanliness of raw materials, components & tools
  • Choose right furniture and get rid of non-essential equipments

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.

 

Frequently Asked Questions ?

A lab may look similar to a cleanroom but there is a difference between both. Cleanrooms are areas that are equipped with ceiling-mounted filtration systems that help remove pollutants from air.

Yes, GMP requires a controlled environment. Usually, there is some kind of medical or medical device manufacturing specification for allowable temperature and humidity that can impact manufacturing of nutraceuticals.

Depending on the criticality of the product, whether it is implantable or sterile, the medical device cleanroom classification can range from ISO-5 to ISO-8.

Medical devices cleanrooms should adhere to FDA’s Good Manufacturing Practice (GMP).

A medical device cleanroom is a space where medical devices - both implantable or for external use are manufactured. At times, it also acts as a cleanroom for supplies at some medical device companies.

All nutraceutical cleanrooms must obey FDA’s Good Manufacturing practices. It should also adhere to ISO 14644-1 standard for air cleanliness as well.

In most cases, nutraceutical applications need ISO 7 or ISO 8 cleanroom classifications. However, particular needs are based on the process and product sensitivity.

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