ISO Cleanroom Standards
Nordell's Cleanroom Standards
We combine 700 years collective knowledge & experience bring tangible savings to your new projects & help refine and develop existing products.
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Learn More »Nordell is one of the UK’s leading independent Plastics Manufacturing and Design refinement companies. It’s over 50 years since its first company registration in 1968 as Component Moulders at King Edward Close Worthing.
Learn More »Nordell (Xiamen) was formally registered in 2018 as a working partnership between Sunled China and Nordell UK. We drive innovation by combining years of manufacturing and engineering knowledge.
Learn More »We employ over 80 people from the local community and are active members of the local Sussex Chamber. We believe in supporting our local community and are pleased to support a number of community initiatives.
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Learn More »At Nordell our Company Mission statement and Core values define the way we work
Learn More »We are an award winning company - and do our bit to sponsor and promote others.
Learn More »The Nordell Customer Charter is a promise to our customers, setting the expectations of how we will do business
Learn More »We really care about the service we offer our customers. “We do what we say, and we do it well”.
Learn More »We offer a full range of complimentary manufacturing services in addition to our principal lastic injection moulding business.
Learn More »Value added services for complete or part-assembled products
Learn More »Helping you to reduce supply chain complexity and risk.
Learn More »Offering a complete Cleanroom solution from Injection moulding through to assembly & final packing.
Learn More »Helping you to reduce supply chain complexity and risk.
Learn More »Our clients, customers and partners operate across a wide variety of sectors and global markets. We have a growing reputation for being able to apply our skills and knowledge across sectors and industry types and love the challenges this diversity brings.
Learn More »The electronics sector demands specialist plastics critical for high or low conductivity. Nordell is able to help you select the right product for your requirements.
Learn More »Keeping waste to a minimum with tight process management and training.
Learn More »Partnering with leading companies in the Environmental sector.
Learn More »Our ISO Class 7 Cleanrooms are certified to ISO 14644 standards.
That means they are capable of providing air cleanliness of a maximum of 352,000 particles per cubic meter at 0.5μm and 60 to 90 air changes per hour.
Our Cleanrooms comply with ISO 14644 standards on air cleanliness, which were established to address the need for uniform Cleanroom classification and testing.
A Cleanroom is usually required in the production of medical, consumable, and other hygiene-sensitive products. They are designed so that contaminants and particle flow can be managed and monitored closely to maintain requirements. ISO classifications run from one to nine, with nine being the least strict when measuring the allowed concentration of particles per cubic meter of air.
As well as air changes, changing / gowning rooms are required must be situated at entry and exit points to reduce the chances of contamination.
For Cleanrooms to adhere to the ISO Class 7 cleanroom classification, there are a number of stringent measures that manufacturers must abide by to manufacture parts including:
Class I or Class II medical devices and pharmaceutical products all require a Class 7 Cleanroom to maintain cleanliness and the quality of the products produced.
For every cleanroom, testing and validation is an essential process.
A cleanroom testing and validation service ensures that the cleanroom is professionally installed and designed for its intended classification and that the regulations and other defined standards for all components are met. Nordell’s cleanroom is validated in line with the required testing schedule by Total Clean Air (TCA) of Portsmouth, Hampshire, which built it.
The cleanroom testing and validation consist of several phases from the design to the final certification. Airflow and velocity tests, a HEPA/ULPA filter integrity leak test, air movement visualisation, airborne particle count tests, room pressure tests, relative humidity and temperature testing are some of the tests conducted in these phases.
Phone: +44 1903 235 765
Monday - Thursday: 08:00 - 17:30 & Friday 8.00 - 12.00
Monday - Thursday: 08:00 - 17:30 & Friday 8.00 - 12.00
Email: enquiries@nordell.co.uk
Monday - Thursday: 08:00 - 17:30 & Friday 8.00 - 12.00