Clean rooms are crucial for manufacturing industries where product quality is easily affected by factors, such as airborne particles. Thus, clean rooms are pivotal in a medical device manufacturing industry. Medical device quality affects the patient outcome. Hence, manufacturers will have to establish effective clean rooms to maintain a sterile and clean environment. In this blog, we will highlight what is a clean room for medical device manufacturing industry and its components. Additionally, we will focus on how to monitor the effectiveness of the clean room.

What is a clean room for medical device manufacturing industry?

Clean room for medical device manufacturing industry is a specially designed sterile setting to minimize entry of aerosol particles and pollutants. It regulates pollutant level, humidity, and personnel access to prevent the entry of dust and germs. Medical device manufacturers need to have a clean room unit within their manufacturing facility. Notably, these rooms provide a controlled and sterile environment for manufacturing and packaging of medical devices. The rooms are specifically designed to maintain low environmental pollutant, such as dust, airborne microbes, aerosol particles, and chemical vapours, levels.

Clean rooms have a vital role in medical device manufacturing industry. Moreover, the rooms have to abide by strict regulations, such as ISO 14644 guidelines. These guidelines mention the amount of particulate matter permissible in this controlled environment. Thus, clean room designing requires a certain level of expertise.

Points to keep in mind while designing a medical device clean room

• Determine the level of cleanliness required for your factory: The clean room cleanliness level will depend on the products being manufactured or assembled in your factory. For example, an ISO 7 clean room is usually sufficient for most medical device manufacturing facilities. However, an ISO 8 clean room may be required for manufacturing lower-risk products.
• Select the appropriate location: It is important to wisely select the location of the clean room for medical device. It should be located away from sources of contamination, such as windows and external doors. Additionally, there should be sufficient space to accommodate the equipment and personnel required for the device clean room.
• Control area: A control area outside of the clean room where personnel can prepare for entry into the room is required. Moreover, this area should be equipped with lockers for storing personal items and have hand-washing and sanitizing stations.
• Air filtration system: An air filtration system appropriate for the cleanliness level will be required. The clean room for medical device manufacturing should have a controlled air supply that is constantly filtered to remove contaminants.
• Protocols maintaining the sterility of the medical device clean room: Protocols for maintaining the sterility and cleanliness of the clean room have to be formulated. Personnel and equipment entering and exiting the clean room have to follow certain decontamination procedures.

We have to keep in mind these points while planning the design for clean room for medical device manufacturing factory.

Components required for constructing and validating a clean room for medical device manufacturing factory

The major components required for constructing a clean room for medical device manufacturing factory are HVAC systems, cleanroom filtration unit, airflow pattern measurement system, and pressurization measurement system. These rooms have to effectively maintain a clean and sterile environment. Thus, they have to be regularly tested for their effectiveness to maintain the permitted particle count limit.

Heating, Ventilation, and Air Conditioning (HVAC) system

The HVAC system regulates moisture, humidity, and temperature variations to maintain a stable environment within the clean room. Thus, it has a vital role in ensuring compliance with cleanroom specifications. The HVAC system controls the circulation of air within the cleanroom.

Cleanroom filtration unit

A filtration unit will be required to filter out particle pollutants. Cleanroom filtration units commonly used are ultra-low particulate air (ULPA) and high-efficiency particulate air (HEPA) filters. ULPA filters can effectively eliminate at least 99.999% of dust, pollen, and other airborne particles as small as 100 nanometres. However, HEPA filters effectively remove 99.97% of the airborne particles up to a size of 0.3 microns. Furthermore, whether the particle count is within the cleanroom’s specified limit has to be regularly checked.

Airflow pattern measurement system

Parameters, such as velocity, directional flow, volumetric flow, and reflux, have to be measured to validate the airflow pattern. The direction of the airflow has to be per the clean room specifications and the medical device being manufactured. Airflow pattern is an important factor to consider while designing the clean room. Thus, an effective airflow pattern measurement system is required.

Pressurization measurement system

Room pressurization measurement system is required to ensure the specific room pressurization is being maintained. Clean rooms are usually required to maintain positive pressure, which prevents contamination of the air by the surrounding environment. Any leaks in the cleanroom can lead to undesirable particles entering the cleanroom, thereby reduce its cleanliness and sterility. Thus, the desired clean room air pressure has to be constantly maintained. Hence, a pressurization measurement system has a crucial role in ensuring the cleanliness and sterility of the clean room.

Why do medical device manufacturing factories need a clean room?

Clean room for medical device manufacturing factory provide a clean, regulated, and sterile environment. These environmental conditions are vital for assembling and manufacturing high quality medical devices. The clean room prevents the entry of both airborne particles and microbes into the regulated area. Airborne particles are harmful for hard drives and microchips used to manufacture medical devices. On the other hand, microorganisms will contaminate the medical devices, thereby making the devices a threat for patient safety. Thus, medical device clean rooms have a pivotal role in medical device manufacturing industry.

How to monitor the effectiveness of the medical device cleanroom?

The medical device clean room has to be regularly monitored to ensure its effectiveness. The cleanroom should be operating as required. Furthermore, regular monitoring will help identify any potential contamination issues.

1. Particle count: A particle counter can be used to measure the number and size of particles in the air to ensure they are within the limit.
2. Monitoring surfaces: The level of contamination on the surfaces within the cleanroom is measured. Swabs can be used to collect samples from the surfaces. Then, they are analysed for the presence of contaminants.
3. Monitoring the personnel working in the clean room: The level of contamination on the clothing and skin of personnel working is monitored.
4. Environmental monitoring: The temperature, humidity, and pressure within the cleanroom are measured using sensors or monitoring devices.
5. Air monitoring: The concentration of contaminants in the air is analysed using air samplers.

Best practices before entering the clean room

1. Gowning protocol should be thoroughly followed prior to entering the room.
2. The personnel should maintain a good personal hygiene.
3. All personal items should be placed in the lockers outside the room prior to entering the clean room.
4. A cleanroom for medical device manufacturing facility should have a hallway connecting to the room.
5. A trash can should be placed at the entrance to dispose of any unnecessary items outside the room.
6. Air showers and pass-boxes should be used to bring new materials into the cleanroom.
7. Designated entrances and exits should be used to enter and exit, respectively.

How can Pharmadocx Consultants help you design medical device clean room?

We at Pharmadocx Consultants design clean room for medical device manufacturing facilities as per international standards and norms. As an experienced clean room design consultant, we have helped multiple facilities design their clean rooms. Furthermore, for regulatory compliance, the clean rooms have to be designed per industry guidelines. Our team of experts will accurately design your clean room as per latest regulatory requirements. To avail our clean room design consultation service, drop an email at [email protected] or call/Whatsapp on 9996859227.