What Is the ISO 14644-1 Cleanroom Standard?

ISO 14644-1:2015 Cleanliness Standard

The ISO 14644-1 cleanroom standard is measure  of the air quality within a cleanroom or laboratory.

The International Organisation for Standardisation (ISO) has developed a cleanliness standard used as a primary source of comparable data to determine air quality within a cleanroom(s) or lab(s) – this is equivalent to the Federal & GMP Standards.

The standard can determine the overall cleanliness of the monitored system/room.

The ISO standard ranges from Class 9 to Class 1 with Class 1 being the cleanest working down to Class 9 being the least clean. The cleaner the desired classification, the lower the maximum allowable concentrations of particulate within the area.

The end-user will establish a target classification to achieve, this offers their consumer the confidence that the products have been manufactured/produced in a comparable level of clean environment.

The ISO standard allows an organisation to set targets and establish goals to achieve/maintain system cleanliness. It is also ideal to use as a key performance indicator (KPI) tracking, charting and posting.

How the ISO Cleanliness Code is Determined

At the end of each cleanroom project, an independent validation company visit site to confirm the agreed ISO cleanliness classification has been achieved within the room before the room is used. They will also provide certification documentation for the end user.

The validation includes a room air particle count amongst other commissioning checks. This establishes the number of particulate at certain micron levels within each area which can be compared to the relevant agreed classification.

Following the validation, the room is ready for use.

Competitive Advantage

In competitive markets, products can be manufactured abroad at a lower cost, maintaining a high measurable level of quality standard is of high importance to gain market share.

On completion of our projects we can provide our quotation to carry out an annual validation to ensure your facility is maintaining the agreed ISO standard.

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