Cleanrooms are an integral part of the medical device assembly process. In situations where hygiene is critical, and ISO class 7 cleanroom ensures that contaminants and particles are managed and monitored to ensure medical devices meet strict requirements. But what is an ISO class 7 cleanroom, what does the class number mean, and why is it essential to work with a medical device manufacturer that offers cleanroom facilities?
We will explore the importance of ISO cleanrooms in medical manufacturing and highlight how Europlaz’s comprehensive design, development, and fulfilment services provide an all-in-one solution for your next medical device project.
Cleanroom classifications – How Europlaz ensures high standards and quality
The ISO class directly relates to air quality with a scale of one through nine (one being the most stringent) determining what level of cleanroom protection is required for a specific product. These classes are incredibly strict with each determining the cleanliness of the air as well as the air particles present and grading room accordingly. This is based on measurements of microns per cubic meter of air and factors into the various ISO cleaning standards ratings.
As a medical device manufacturer with ISO class 7 cleanrooms, we offer spaces specifically designed for processing Class I and Class II medical devices. These requirements include safety measures such as separate changing rooms, regular air testing, and highly efficient HEPA filters which work around the clock with 99.997% efficiency at 0.3 microns.
This accuracy ensures a controlled environment where products can be produced to exacting ISO cleaning standards to ensue the same conditions for every device. To learn more about the types of cleanrooms we offer and how they relate to ISO 14644 please consult our piece on everything you need to know about cleanroom classifications.
What are the benefits of an ISO Class 7 Cleanroom?
ISO class 7 cleanrooms offer a level of control that regular manufacturing doesn’t. As explained above, the use of specialised air filters, safety practices, and regular testing means we offer spaces for medical device manufacture that are clean, controlled, ands safe. You can learn more about the requirements of ISO class 7 cleanrooms here.
A certified ISO class 7 cleanroom also means that we are able to produce class I and class II medical devices. This opens up our capabilities to include a wide range of devices that fit under umbrella definitions for medical devices with low risk, and medical devices with low to medium risk which runs the gamut from single-use tests to inhalers, and other specialised medical devices.
What products can be produced in an ISO Class 7 Cleanroom?
ISO Class 7 cleanrooms allow us to produce products such as Class I and Class II medical devices (as mentioned above) but additionally open the door to a range of processing methods commonly used in medicine. These include blister packaging and pouch sealing for medication, devices, and other medical equipment, manual and automatic medical device assembly, and welding.
These services cover a variety of products and medical devices and show how important production with the assistance of ISO class 7 cleanrooms is to the medical manufacturing community.
ISO Class 7 Cleanrooms at scale
Our site covers 60,000 sq ft with our advanced ISO class 7 cleanrooms (certified to ISO 14644 for airborne particulate) covering 9,500 sq ft. Europlaz is also home to a large number of injection moulding machines ranging from 10 to 300 tonnes, as well as packaging, welding, printing, and bonding. These processes are managed by our expert team who regularly manage and review projects to ensure they meet your needs.
All of this equipment, the large site, and our dedicated team mean we are capable of managing orders of all volumes. Whether you want to create a new product and bring it to the market, or just want to increase production so patients can get the care they need faster, we have the perfect setup to grow production at scale.
Europlaz – a trusted medical device manufacturing partner
As a stalwart in the industry, Europlaz has been a central figure in optimising all stages of the medical device manufacturing process for decades. Our team has worked with a wide range of clients from multinational corporations to SMEs and has experience with both general usage and highly specialised medical equipment.
Our ISO class 7 cleanrooms are an important part of the overall process and one we pride ourselves on providing to customers. As part of our design, development and manufacturing process, our cleanrooms ensure the highest ISO cleaning standards are maintained and give you complete control over every step of production.
If you’re interested in finding out more about our services or want to know more about how we adapt solutions to your needs please contact us now. Our commitment to quality has allowed us to expand our operation and gain experience in a wide range of MedTech device design, development, and manufacturing.