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ISO Class 7 Cleanrooms: Requirements

ISO class 7

ISO Class 7 Cleanrooms: Requirements

What is a Cleanroom?

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 along the lines of the allowed concentration of particles per cubic foot or meter of air. As well as air changes, facilities like gowning rooms and sticky mats on entry and exit points can be required in order to maintain manufacturing standards and to reduce the chances of possible contamination. We’ve compiled a more comprehensive list in the next section.

Minimum requirements for ISO Class 7 cleanrooms

For Cleanrooms to adhere to the ISO Class 7 cleanroom classification, there are a number of stringent measures that manufacturers like Europlaz have to abide by to manufacture medical devices, these include;

30 to 70 air changes per hour.
352,000 PPC (particles per cubic meter) at 0.5μm, 83,200 PPC at 1μm and 2,930 PPC at 5μm
Required testing (ISO 14644-2) every six months.
A separate room for gowning.

Class I or Class II medical devices, equipment or pharmaceutical products all require a cleanroom of this nature. The measures help to maintain cleanliness and, therefore, the quality of the products produced.

ISO Class 7 cleanroom industries

ISO Class 7 rooms provide air cleanliness of a maximum of 352,000 particles per cubic meter at 0.5μm and 60 to 90 air changes per hour. While Europlaz has 7 of these cleanrooms for medical device manufacturing, many other industries also utilise the ISO class 7 certification for a range of processes. These include:

Medical device manufacturing
Electronics manufacturing
Pharmaceutical compounding
Aerospace product development

What methods require class 7 cleanrooms?

Cleanroom classifications can differ depending on the industry or product concerned. Examples of some processes that require this classification and that we at Europlaz offer are:

Manual, semi-automatic and fully automatic medical device assembly
Ultrasonic welding
Hot-plate welding
Hot-wire welding
Blister packaging
Pouch sealing

As a registered FDA equipment manufacturing establishment, Europlaz’s Class 7 Cleanroom production and assembly certification is as follows: ISO 13485:2016 and BS EN ISO 9001-2008. This qualifies us to produce class I and class II medical devices, in part or in whole. With seven clean rooms covering 9,500 sq ft, it enables us to support complete medical device assembly, with a range of services ranging from injection moulding to packaging solutions.

If you are interested in taking your design or idea to the next level or are looking to outsource any of the services provided here at Europlaz, please don’t hesitate to contact us.

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