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Medical Modular cleanroom Classifications Explained

If you are working in the medical industry, then you will need to use modular clean rooms. Most industry leaders and production managers will argue that a cleanroom is essential for the smooth functioning of medical institutions. Medical institutions need to have specific devices that are precise and accurate. A cleanroom is essential because it can provide the necessary space for looking after these devices. So, if you are thinking of setting up a new medical lab or a medical device manufacturing unit, then you need to invest in a modular cleanroom. In this article, you will learn more about the importance of these modular cleanrooms in medical facilities.

Why is a cleanroom critical?

A cleanroom can provide much-needed stability and reliability in medical devices. You will get a lot of control over your molded fittings, and hence, your medical devices will also become better. Thus, these devices can be safe for use during patient care or surgical procedures and operations. 

A lot of medical labs consider if they should outsource the manufacturing of their devices and if they ought to outsource it to a company that uses clean rooms to manufacture the components. Some labs have their own in-house clean rooms where they prepare the devices themselves. However, both lab owners and doctors understand how medical devices can have a positive attribute if they are manufactured from clean rooms, which makes the products more reliable. 

Classification of cleanrooms

In general, cleanrooms can be regulated or classified by the International Organisation for Standardisation (ISO) inside the USA. In Canada, it is done by the ISO 14644-1. Such a regulation procedure categorizes clean rooms from level 1 to level 9 where level 1 has the highest standards of cleanliness while level 9 has the least. 

Most of the clean rooms fall under ISO classes 5 and 7. The class of the cleanroom depends largely on the cleanliness inside the space of the lab and if it is in compliance with the regulated quantity and sizes of particulate matter inside the working environment. Clean rooms acquire air purity through the use of High-Efficiency Particulate Air (HEPA) filters. Generally, clean rooms will serve in ensuring that small particles do not affect or interfere in the manufacturing process through strict control over the humidity, temperature, or pressure in the working environment.

Scrutiny over medical devices

Generally, medical devices and their spare parts go through an intense inspection process where government bodies check their sterility levels. Clean rooms can offer a lot of reassurance to medical device users and manufacturers that their fittings can comply with all essential safety requirements. 

Utility of Cleanrooms

When you manufacture, assemble and inspect medical devices within clean rooms, then you can easily achieve the required sterility and safety standards. Clean rooms themselves have their own standards to follow, and hence, all production work in such environments is also in compliance. 

Benefits of cleanrooms

A cleanroom environment can provide a lot of reliability to the manufacturer. Manufacturers can be certain that regular contaminants like dust and particulate matter do not harm the production process. The component manufacturers will be able to instill trust in their customers, like hospitals and doctors, who would be willing to use their devices. Overall, the entire standard of the medical industry will depend upon the efficacy of the cleanroom.

What are the steps to take before starting production in the cleanroom?

It is important to have cleanroom furniture properly to ensure the efficiency of the working environment. Always be ready with spare parts in case any machine breaks down or malfunctions. Also, test the cleanroom thoroughly before beginning the production process.

You can easily purchase cleanroom equipment and medical equipment from lab equipment suppliers. You can choose to purchase from both online and offline suppliers. However, online suppliers will provide you with better deals and more variety of products because of having a larger inventory. You must remember to check up on the credentials of your supplier before you place an order. 


Having a clean room will help you get more control over your medical facility’s operations and functionality. Medical devices would be safer to use, and their parts would be reliable for doctors. A cleanroom will add immense benefits like efficiency, competency, and accountability to the medical industry. Hopefully, the information mentioned in this article will have highlighted the essential nature of modular clean rooms.