{"id":719,"date":"2020-08-13T08:30:00","date_gmt":"2020-08-13T08:30:00","guid":{"rendered":"https:\/\/www.medisurge.com\/?p=719"},"modified":"2020-09-03T12:11:27","modified_gmt":"2020-09-03T12:11:27","slug":"iso-class-7-cleanroom-faq","status":"publish","type":"post","link":"https:\/\/www.medisurge.com\/medical-device-manufacturing\/iso-class-7-cleanroom-faq\/","title":{"rendered":"ISO CLASS 7 CLEANROOM FAQ"},"content":{"rendered":"\n
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ISO Class 7 Cleanroom FAQ<\/h1>\n\n\n\n
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Here at MediSurge, we utilize an ISO Class 7 Cleanroom<\/a> <\/strong>to create high-quality, reliable medical devices. However, we\u2019ve found that we get a lot of questions about our Cleanroom. That\u2019s why we\u2019re taking the time to address some of the things we get asked the most!<\/p>\n<\/div><\/div><\/div>\n\n\n\n

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Here at MediSurge, we utilize an ISO Class 7 Cleanroom<\/a> to create high-quality, reliable medical devices. However, we\u2019ve found that we get a lot of questions about our Cleanroom. That\u2019s why we\u2019re taking the time to address some of the things we get asked the most!<\/p>\n\n\n\n

What Does Class 7 Mean?<\/strong><\/h3>\n\n\n\n

First and foremost, the ISO rating system starts with Class 9 (the lowest class) and leads all the way up to Class 1. These classes are determined based on how often the air circulates in the space, the particulate count in the air, and more.<\/p>\n\n\n\n

In order to manufacture medical devices for surgery, companies are required to utilize an ISO Class 8 Cleanroom<\/a>. Our team decided to go one step further and build our own ISO Class 7 Cleanroom, to make sure we were going beyond just meeting the requirement. It just shows our level of dedication to creating medical devices that change lives.<\/p>\n\n\n\n

Where is Your Cleanroom?<\/strong><\/h3>\n\n\n\n

This is a great question. A lot of medical device companies need to work with other organizations to gain access to one communal ISO Cleanroom. Instead, our team decided we wanted to have full control over how the Cleanroom functions.<\/p>\n\n\n\n

In order to do that, we built a 1,000-square-foot Cleanroom right in the middle of our central office. That way, we always know what\u2019s going in and out of the room, and we can be sure it\u2019s up to our standards. We keep a close eye<\/a> on key Cleanroom metrics, so even if there\u2019s a minimal fluctuation, our team knows about it before it becomes a problem.<\/p>\n\n\n\n

How Do You Enter the Cleanroom?<\/strong><\/h3>\n\n\n\n

When it comes to something so highly monitored, you can probably assume people can\u2019t just stroll on in. You have to know the secret password, of course. That would be fun, but in reality, in order to gain access to our Class 7 Cleanroom, our team must sanitize, put on proper equipment, and pass through an airlock.<\/p>\n\n\n\n

By doing this, we make sure the ISO Class 7 Cleanroom stays just that\u2014clean. Then we manufacture, assemble, and package all of our devices in this space, so we know they\u2019re ready for surgery when your team needs them.<\/p>\n\n\n\n

Do you have questions about our process or how we manufacture high-quality medical devices? Reach out to our team.<\/a> We\u2019d love to tell you more.<\/p>\n\n\n\n

Request a Quote<\/h3>\n\n\n\n\n
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