Cleanrooms for Medical Device Manufacture
Just as the medical device industry is governed by its own set of standards, cleanrooms must conform to ISO 14644-1:2015. The standard contains a range of classes with clearly defined particle concentration limits that determine the cleanliness of an environment. A cleanroom for medical device production must be designed to achieve the appropriate class of air cleanliness and the nature of the process often dictates the classification required.
EU GMP-compliant medical cleanrooms will also be classified according to the test methods in ISO 14644 but may have different limits and may require additional testing.
Medical cleanroom classifications
Let’s take a look at some of the applications for ISO 14644-1 and EU GMP Cleanrooms in the Medical Devices fields and the crossover between the two standards.
Medical Devices are regulated by the Medical Devices Regulations (MDR) 2002. All medical devices are given a classification depending on the level of risk associated with the device. The strictest control is for products with the highest risk.
- Class I – generally regarded as low risk
- Class IIa – generally regarded as medium risk
- Class IIb – generally regarded as medium risk
- Class III – generally regarded as high risk
Most medical cleanrooms intended for the manufacture of Medical Devices must comply with ISO Class 5 to Class 8 standards so can be manufactured in an ISO cleanroom. However all active implantable medical devices and their accessories fall under the highest risk category (Class III).
A Class III Medical Device includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device. These devices should be manufactured in a GMP cleanroom.
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