ISO 14644-1 Cleanroom Standard

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…

"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

"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 Hammond

Managing Director, Intertek Melbourn Scientific

"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 Talbot

Managing Director, P3 Medical Ltd

"Great company to work with. Our cleanroom was designed and constructed by Airology and they still service and validate for us. Would definitely recommend"

Helena Flowers

Andel Plastics Ltd

"We engaged Airology for modifications in our Clean Room at our pharmaceutical company. The communication with their technical team was exceptionally effective. The service provided was of the highest quality, making them an excellent choice for conducting business."

Suzani Menegon

SyriMed Ltd

"Airology have recently designed and built our cleanroom. They were a pleasure to work with and provided a very professional service. I would have not hesitation in recommending the team."

David Shand

MatOrtho Ltd

"Airology have always been professional and helpful when we have needed advice at Insight Medical Products with our Cleanroom. Thoroughly recommend."

Stacey Spruels

Insight Medical Products Ltd

"Professional company, very friendly and experienced team. They designed for our pharmaceutical site the best flexible and efficient HVAC considering practicality, potential to expand and costing. I would recommend working with this company. They are very transparent and keen to solve any difficulties during the project."

Zakaria Saad

Medellux Ltd