Cleanrooms have a vital role in maintaining the controlled environments necessary for manufacturing sterile medical devices. They offer a sterile and specialised environment. Medical device manufacturers will have to establish effective clean rooms to maintain a sterile and clean environment. Moreover, designing clean rooms requires a certain level of expertise, as regulatory guidelines and international standards are in place. In this blog, we have discussed the role of cleanrooms in manufacturing sterile medical devices.
What is a clean room in the medical device industry?
Clean room is a sterile and controlled environment specially designed to minimize entry of aerosol particles and pollutants. It regulates pollutant level, humidity, and personnel access to prevent the entry of dust and germs. A clean room unit is mandatorily required in a medical device manufacturing facility. The rooms are specifically designed to maintain low environmental pollutant levels. Notably, these rooms provide a controlled and sterile environment for manufacturing and packaging of medical devices. Various components of a clean room are involved in maintaining the sterile and clean environment.
We have specifically focussed on the role of cleanrooms in manufacturing sterile medical devices. Product contamination is a huge risk while manufacturing sterile medical devices. It could compromise patient safety or lead to regulatory non-compliance. Hence, cleanrooms have to be used while manufacturing sterile medical devices.
Key components of a clean room
- Heating, Ventilation, and Air Conditioning (HVAC) system: HVAC system regulates moisture, humidity, and temperature variations to maintain a stable environment within the clean room.
- HEPA filtration unit: HEPA filters effectively remove 99.97% of the airborne particles up to a size of 0.3 microns.
- Airtight enclosure: A cleanroom must be an airtight enclosure. Proper sealing prevents contaminated air from entering the clean room area. External pollutants are to be kept out to maintain a sterile environment.
- Airflow pattern measurement system: 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 vital.
- Pressurization measurement system: Clean rooms are usually required to maintain positive pressure, which prevents contamination of the air by the surrounding environment. Thus, a room pressurization measurement system is required to ensure the specific room pressurization is being maintained. Hence, a pressurization measurement system has a crucial role in ensuring the cleanliness and sterility of the medical device clean room.
- Control area: The control area is a dedicated area outside the cleanroom where personnel prepare for entry into the clean room.
- Air purifiers: At the entry of these clean rooms, air curtains and air purifiers are placed. They blast filtered air over personnel entering the room to ensure they are free of external particles.
- Airlocks: The integrity and sterility of the clean room is maintained using airlocks. Air locks are specialized units that act as transitional zones. They act as a buffer between different cleanliness zones. Airlocks prevent contaminants from infiltrating and contaminating the cleanroom.
What is the role of cleanrooms in manufacturing sterile medical devices?
Sterile medical devices will have to be manufactured in strictly regulated environments. Contamination of these devices will be detrimental for patients. This will lead to product recalls and regulatory actions. We have discussed the role of cleanrooms in mitigating these risks while manufacturing sterile medical devices.
- Microbial and particulate contamination control: Cleanrooms are equipped with HEPA or ULPA filtration systems. These systems continuously filter the air, thereby maintaining low levels of airborne particles and microorganisms. These filtration systems ensure sterile medical devices remain uncontaminated during manufacturing, packaging, and sterilization processes. Control of microbial and particulate contamination is a major role of cleanrooms.
- Compliance with global regulatory requirements: Most regulatory authorities require manufacturers involved in manufacturing sterile medical devices to use cleanroom environments. Environmental monitoring and cleanroom control are required to safeguard product sterility.
- Patient safety: The role of cleanrooms impacts the product as well as the patient. Cleanrooms prevent the risk of infection caused by contaminated devices. Hence, they help avoid complications that could arise from contaminated implants, catheters, surgical tools, or diagnostic kits.
Classification of cleanrooms for manufacturing sterile medical devices
The cleanroom classification system is based on international standards, such as ISO 14644-1:2015 or EU GMP Annex 1. Cleanrooms are classified based on the maximum allowable concentration of airborne particles. ISO Class 1 to ISO Class 9 cleanrooms are usually used for manufacturing sterile medical devices. The exact class required will depend on the specific manufacturing process of the medical device. We have discussed the role of different cleanroom classes in manufacturing sterile medical devices.
- Sterilization preparation: ISO Class 6–7 cleanrooms are used for preparation of sterilization of medical devices.
- Aseptic filling or critical operations: ISO Class 5 cleanroom is required for aseptic filling or critical operations in manufacturing medical devices.
- Moulding: ISO Class 9 cleanroom is required for moulding of components of medical devices.
- Component assembly: ISO Class 7–8 cleanrooms are used for component assembly.
- Packaging: ISO Class 7 cleanroom is required for packaging medical devices in final sterile barrier.
How to operate a clean room?
Strict protocols are in place for operating a clean room. The components of a clean room should be maintained per these protocols. These guidelines are necessary to control contamination, maintain cleanliness, and ensure product integrity. Controlled access and gowning procedures have to be followed for entry into the clean room. Personnel should be trained with clean room operation protocols to minimize contamination risks. Moreover, air quality has to be maintained using HEPA filtration. Positive pressure has to be maintained to prevent particle ingress. Furthermore, environmental parameters, such as humidity, temperature, and particle counts, have to be continuously monitored. Additionally, equipment and materials entering the clean room have to be disinfected or sterilized as per standard guidelines. Moreover, equipment should be properly calibrated and maintained as well as all processes should be properly documented.
The clean room operation should be per ISO 14644 guidelines and should comply with all applicable regulatory requirements. Finally, the room has to be regularly cleaned using approved disinfectants.
What is the role of cleanroom validation and monitoring?
Continuous validation and environmental monitoring are required to maintain the cleanroom’s effectiveness. Validation will ensure the environment consistently performs within prescribed limits, thereby ensuring consistent sterile environment for medical device production. We have highlighted some parameters that should be tested and validated.
- Microbial contamination level
- Air particulate count
- Temperature and humidity
- Airflow patterns
- Pressure differentials
Notably, ISO 14644 guidelines mention tests that have to be carried out to validate the effectiveness of the cleanrooms.
How can we help you establish a clean room?
Cleanrooms are highly specialised segments of a medical device manufacturing facility. We have also discussed the indispensable role of cleanrooms in manufacturing sterile medical devices. Hence, medical device companies should hire experts to ensure cleanroom layouts, airflow patterns, and filtration systems align with both regulatory and operational requirements.
We at Pharmadocx Consultants design clean room as per international standards and norms. As an experienced clean room design consultant, we have helped multiple facilities design their clean rooms. Our team of experts will accurately design your clean room as per latest regulatory requirements. Our comprehensive cleanroom service includes:
- Cleanroom layout, zoning layout, and classification planning
- Cleanroom planning
- HVAC system planning and establishment
- Cleanroom validation and document preparation
- Regulatory gap assessment
- Providing strategies for regulatory compliance
- Environmental monitoring strategy development
Email at [email protected] or call/Whatsapp on 9996859227 and our team of experts will be more than happy to design your cleanroom.
