Medical Device Cleanroom Design and Construction Solutions – Medical Device Network

Skilled Guardtech engineers perform cleanroom installation, with the support of certified, fully trained subcontractors for specialist services.

The company are experts at testing controlled environments with clean air devices to guarantee continuing International Organisation of Standardisation (ISO)14644-1: 2015 certification or current Good Manufacturing Practice (cGMP) compliance.

All Guardtech installation team members comply with stringent site health and safety regulations, providing risk assessments and method statements (RAMS) for every project, shared ahead of all work conducted for customer review. Installation managers are also in place for each installation while site managers attend each project falling under construction design and management (CDM) coordination.

Custom medical device cleanroom design

Whether customers are beginning from a blank canvas, have an idea that needs refining, or have fully prepared sketches, Guardtech can work in unison with companies to figure out the best balance for the budget, offering a medical device cleanroom design that meets the requirements of each process while improving facilities and delivering a safe, healthy working environment for all users.

The company develops its cleanrooms following building control, Medicines and Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) requirements, Construction (Design and Management) (CDM) regulations, health and safety, ISO 14644, and all appropriate industry guiding principles and standards.

Medical device cleanroom validation processes

Guardtech offers a full cleanroom validation process to ensure controlled environments perform to specifications. Offering in-house or independent testing, the company can assist with the entire validation lifecycle, including operational qualification (OQ), design qualification (DQ) and installation qualification (IQ).

Testing includes filter integrity leak testing, room differential pressure testing and air velocity and volumetric flow rate measurement, as well as pressure and flow gauge calibration, lighting and noise level checks, temperature monitoring, airflow balancing and visualisation and airborne particle counting.

Turnkey cleanroom project equipment

Guardtech provides a vast array of medical device cleanroom equipment delivered and installed together with turnkey cleanroom projects.

The company can advise clients on the best solution, ranging from devices for personnel to product protection or transfer hatches to enhance material flow.

The portfolio includes nitrogen generators, laminar flow units, fume cupboards, download booths, desiccators, air showers and much more.

To contact the company regarding its products and services, please use the form below.