Manufacturers of medical devices rely on cleanrooms to ensure their products are secure enough to be sold. Medical equipment is designed for use in healthcare environments where maintaining cleanliness and avoiding cross-contamination are top priorities. Together, these tools enable healthcare professionals to identify and treat patients, enhancing their quality of life. Read on to learn more.

What is a cleanroom?

A clean room is a space with minimal environmental pollutants, such as dust, airborne germs, aerosol particles, and chemical vapours, generally employed in manufacturing or scientific research. More precisely, a clean room has a controlled level of contamination determined by the number of particles per cubic meter at a given particle size.

How do cleanrooms support medical devices?

Medical device manufacturers must overcome various obstacles when planning and running a cleanroom. The patient’s safety must be considered while designing cleanrooms to control airborne particles and bacteria. Designing an ideal cleanroom is essential to creating a safe product since environmental controls are essential to implementing a device. As with any other cleanroom design, you must consider factors like temperature, humidity, air movement, and other environmental factors that could put the product in danger of contamination, impair the cleanroom’s general environment, or both.

What cleanroom classifications are used for medical devices?

Because of the complexity of cleanrooms, each design should be handled individually. We have observed that facilities tend towards a cleaner classification than is now required to future-proof their construction for the changing process needs as device complexity increases and particles become more problematic.

Steps to follow.

It is necessary to take the following actions to set up a clean room for the medical device industry:

  1. Establish the level of cleanliness: The precise specifications of the goods being made or assembled will determine the cleanliness needed in a clean room. For the majority of medical device manufacturing, a Class 10,000 clean room (also known as an ISO 7 clean room) suffices, although a Class 100,000 clean room (also known as an ISO 8 clean room) may be necessary for lower-risk goods.
  2. Pick a suitable location: Place the clean room away from potential sources of contamination, such as windows, doors, and HVAC units. The location should have enough area and power to accommodate the clean room’s equipment and workers.
  3. Install an air filtration system: Clean rooms require filtered, controlled air supplies to keep pathogens out. Install an air filtering system that meets the standards of cleanliness.
  4. Build a control area: Create a controlled space outside the clean room where staff members can don protective gear and get ready to enter the clean room. Lockers for securing personal goods should be present here, along with hand-washing and sanitizing facilities.
  5. Design processes for personnel and equipment: Design processes for personnel and equipment entering and leaving the clean room. These protocols should include decontamination and gowning procedures. To keep the clean room clean and sterile, establish cleaning and maintenance processes.

What are ISO 14644 cleanroom environments for medical services?

The production of these kinds of medical gadgets is best done in cleanrooms. Cleanrooms are enclosed, environmentally controlled facilities with tightly regulated temperature, humidity, pressure, and contamination levels. A clean room’s regulated atmosphere helps to guarantee that products maintain controlled contamination levels throughout the production process, lowering the danger to patients.

How clean is a clean?

The amount and size of airborne particles per cubic meter of air, or the cleanliness level of the air inside the controlled environment, is used to categorize clean rooms. Class 1 is the cleanest cleanroom environment, and Class 9 represents room air, according to the ISO 14644-1 categorization standard. When the classification number drops, the standards governing cleanrooms become more stringent. ISO Classes 7-8 make up the majority of cleanrooms, with ISO 5 serving as a transitional level where stringent filtration, contamination, and environmental control standards are enforced.

What is a cleanroom “at rest” vs. “in operation”?

When a cleanroom is not in use or when all of its systems are functioning but no people or equipment are present, it is said to be “at rest.” Usually, this serves as the benchmark against which the cleanliness of the space is measured. The phrases “at rest” and “in operation” describe various cleanroom conditions.

While a cleanroom is in use and has people and equipment inside, it is said to be “in operation.” Particles and other pollutants produced by processes, equipment, or people moving around will increase during this stage. To determine how to clean something while it is “in operation,” standards and norms created for that application or industry are often used.

How to design and validate the cleanliness of a cleanroom?

  • Cleanroom filtration: A cleanroom’s air filtration system is crucial. The filters are made to filter out airborne particles as small as sub-microns.
  • Airflow patterns: Every cleanroom is intended to keep a specific level of cleanliness and ISO classification, and designing and maintaining a correct airflow pattern is a key part of adhering to those requirements. The ISO 14644-4 annex section is devoted entirely to discussing the required airflow patterns for preserving low contaminant and particle counts.
  • Pressurization: A variety of industries and applications use pressurized cleanrooms. The way air naturally travels in an area is determined by the varying pressures present.
  • HVAC system: Heating, ventilation and air conditioning (HVAC) systems are made to satisfy environmental standards for occupant comfort and a process.

Which Recommended Practices Should You Follow Before Entering a Cleanroom?

  • Keep personal effects outside of the restricted area
  • Keep food, cigarettes, and gum out of the cleanroom
  • Avoid donning cosmetics, fragrances, etc., inside the cleanroom
  • Within the safe space, don’t rush or move more swiftly than necessary
  • If you’re sick, do not enter the cleanroom

Can an auditor challenge the Cleanroom Specifications?

Suppose an auditor discovers any anomalies or problems while conducting their audit. In that case, they can challenge the Cleanroom Specifications because they don’t adhere to industry or regulatory requirements.

Who can help you design your cleanroom?

A team of project designers, engineers, construction managers, project managers, and some management team will normally develop all the components of a cleanroom project. CEOs, directors of engineering or operations, and middle-level facility managers might all fall under this category.

What Is The Estimated Cost Of Building A Cleanroom?

The modular cleanroom cost can vary depending on the type of cleanroom, from less than $100 to more than $1,000 per square foot, even though there are projects that cost more or less than these ranges in 90% of cases.

How to monitor a cleanroom effectively?

  • Air monitoring: To detect the concentration of airborne particles and microorganisms, you can use particle counters or microbiological samplers, among other techniques
  • Particle counting: Particle counting determines the number of airborne particles in a given air volume. The cleanroom’s air cleanliness class is normally determined using these measurements.
  • Surface monitoring: Contamination-free surfaces are required in cleanrooms. Surface monitoring is wiping or swabbing cleanroom surfaces, then testing the samples for particle or microbiological contamination.
  • Personnel monitoring: Personnel monitoring entails looking for contamination on the skin, hair, and clothing of those using the cleanroom
  • Environmental monitoring: External variables, including temperature, humidity, and air pressure, can have an impact on cleanroom conditions.


As they offer a controlled environment devoid of pollutants that could jeopardize the safety and effectiveness of medical devices, cleanrooms are a crucial part of the medical device business. The atmosphere in a clean room for medical devices is strictly controlled, and the air is filtered to reduce the presence of particles, bacteria, and other pollutants.

Typically, medical device production takes place in a cleanroom with an ISO rating of 5 (Class 100) to 8 (Class 100,000).

Less than two particles larger than 0.3 microns and no particles larger than 1.0 microns per cubic meter are required by the ISO 1 specification for cleanrooms. Less than 11 particles larger than 0.3 microns and no particles larger than 1.0 microns per cubic meter are needed for the ISO 2 cleanroom specification.

The requirements for a medical device manufacturer's quality management system are laid forth in ISO 13485. (QMS).

The "cleanest" cleanroom is ISO 1, utilized in sectors like electronics and biological sciences that need to process nanoparticles or ultra-fine particulates.

There are now two main categories of cleanrooms, distinguished by how they ventilate. These cleanrooms have unidirectional flow and turbulent ventilation.

The second-lowest cleanroom classification, ISO 8, is used. A room or enclosed environment designated as an ISO 14644-1 cleanroom must maintain low particle counts.

Use a neutral detergent and water to do scheduled cleaning on objects or surfaces that aren't typically at risk of becoming soiled.

A medical device quality management system (QMS) is an organized set of protocols and practises that address all facets of design, production, supplier management, risk management, complaint handling, clinical data, storage, and distribution, product labeling, and more.

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