Medical Device Cleanroom

Airology are experts in Medical Device Cleanrooms.

We produce bespoke quality cleanrooms for medical device manufacturers, making the best use of space to ensure sterile, controlled environments for procedures and preparation.

Cleanrooms for medical device assembly ensure devices such as surgical implements, artificial implants, syringes, etc. can be assembled to GMP standards. Any sterile implement or device used for medical purposes must be produced in a sterile environment to ensure the safety of patients and users.

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Why Medical Devices Manufacturers Need a Cleanroom

A cleanroom is a controlled environment, regularly changing and filtering the air within the room to reduce the particulate matter in the atmosphere. This means removing and preventing the presence of dust, dirt, and microorganisms.

In medical device manufacturing, a cleanroom is required to prevent the contamination of the device with bacteria or viruses, and subsequent infection of patients. For devices used internally, all parts should be processed and packaged in a cleanroom environment.

Surgical Pack Cleanrooms

Cleanrooms are indispensable in the production of surgical packs due to the critical need for sterility and infection control in medical settings. Surgical packs consist of various sterile items, including surgical instruments, drapes, and gowns, that are used in operating rooms.

Cleanrooms provide a controlled environment with meticulously maintained air quality, temperature, and humidity levels, effectively minimising the presence of contaminants such as dust, microbes, and particulate matter. This stringent control ensures that the surgical packs are assembled and packaged under conditions that meet or exceed the highest standards of cleanliness and sterility, thus reducing the risk of surgical site infections and other complications during medical procedures.

In the healthcare industry, where patient safety is paramount, cleanrooms play an essential role in maintaining the quality and reliability of surgical packs, ultimately contributing to better patient outcomes.

Medical Device Cleanroom Assembly – Cleanroom Classification

The classification of cleanrooms determines the number of airborne particles permitted per cubic metre of space. There are three main classifications that we work with: ISO, GMP and FED.

All of these classify cleanrooms based on the maximum allowable concentrations (particles/cubic metre) for particles of certain sizes for each class.

ISO standards, derived from ISO 14644-1, are numbered 1 to 9, with 1 being the cleanest and 9 being similar to any other, non-ventilated room.

What are the Requirements for a Cleanroom in Medical Device Industry?

Generally, medical device manufacturing takes place in a cleanroom classified between ISO 5 (GMP A/B) to ISO 8 (GMP C/D). In practical terms, this means between 25 and 240 air changes per hour to remove particulate matter and microorganisms.

Depending on the sensitivity of the materials used, a cleanroom may also need to control other atmospheric conditions, including light levels, temperature, air pressure and humidity.

The requirements of your specific cleanroom project will depend on the intended use and design. Our cleanrooms are validated by an independent inspector on completion, so you can be confident that the installation meets ISO requirements.

Why work with Airology Systems for your medical device cleanroom?

With over 25 years of experience in the cleanroom industry, we have extensive knowledge of cleanroom technology and classifications. With this knowledge and experience, we support you with the design and management of your whole cleanroom project, from initial concept to completion.

Once the design is finalised, we provide and liaise with specialists to install high-tech, high-quality solutions, creating a secure, controlled environment in your space. We are available for guidance throughout the project, by phone or email, and happy to offer advice where needed. On completion of the build, we arrange an independent validation assessment, giving you confidence that our solutions meet the specifications required.

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Medical Case Studies

Exstent Ltd, ISO 5, ISO 6 & ISO 7 cleanroom, Tewkesbury

Blink Medical / Corsa Medical, ISO 7 Cleanrooms, Solihull

What our customers say…

“Throughout the project Airology provided us with guidance and their expertise to ensure that the installation met our specific requirements and was completed on time. We are delighted with our state of the art Clean Room and the professional approach and support given to us by the Airology team was invaluable.”

Andrew Stringer Managing Director, Entaco Ltd

“During the initial design and build we worked closely with Airology to create a facility that will provide one of the most comprehensive GMP stability storage and testing services in Europe. Working with Airology as the principal contractor enabled us to deliver a significant building project, on-scope, on-time and on-budget.”

Mark HammondManaging Director, Intertek Melbourn Scientific

“We have used Airology extensively to install air conditioning in Grosvenor House so wanted them to handle the M & E but we also wanted a single locally based supplier for the refurbishment contract. Airology were able to provide a comprehensive service including the raised floor, ceilings, decoration and carpeting as well as the M & E and the project came in on budget, on time and the quality was excellent.”

Mark RobertsManaging Director, Loxton Developments Ltd

“Airology provided us with a bespoke, managed development which has allowed us to double our production output. The service and communication which we received at all stages of the project was excellent and any impact on our production was kept to an absolute minimum. Malosa Medical would definitely recommend Airology.”

Will Stewart Operations Manager, Malosa Medical

“Airology completed our installation with a high degree of professionalism and knowledge. P3 would have no hesitation in recommending the company for similar projects.”

Simon TalbotManaging Director, P3 Medical Ltd

“We would like to thank you for the way the works were carried out to a high standard with the minimum of disruption. From concept to completion your staff were very helpful and professional throughout. We would be pleased to recommend you in the future without hesitation.”

Dr SilvaPerfect Image Consultants

“The quality of the work has been to a high standard and the people who have worked on the project have been exceptional. There were some challenges to be dealt with, but as we thought the Airology team was first class at solving the problems and kept the project to time and to budget.”

Nigel SouthernRidgeway Biologicals

“I have worked with Airology for several years and always found them to be reliable and responsive in regard to the servicing and maintenance of our HVAC equipment.”

Colin Welsh Orbit Group

Other Case Studies…

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Paragraf, Somersham - ISO 6 & ISO 8 Cleanrooms

They required a GMP Grade B, C and D cleanroom facility with temperature control, filtration, pressure monitoring and ventilation.