Cleanrooms are critical in healthcare manufacturing to ensure the safety and efficacy of medical products. Designing a cleanroom requires careful consideration of various factors to ensure that the facility meets the required standards for cleanliness and safety.
This article will discuss seven key considerations and best practices for designing cleanrooms for healthcare manufacturing.
1. Regulatory Requirements for Manufacturing Practice
One of the most important regulatory standards is Good Manufacturing Practice (GMP). It outlines the minimum requirements for manufacturing processes and facilities to ensure that products are consistently produced and controlled to meet the required quality standards. GMP covers various topics, including personnel, equipment, facilities, documentation, and quality control.
When designing cleanrooms, it’s crucial to distinguish between GMP and current Good Manufacturing Practices (cGMP). To better understand the GMP vs. cGMP differences, online resources like American Cleanroom Systems can be helpful.
American Cleanroom Systems explain that GMP comprises a set of guidelines that ensure the safety and quality of products. On the other hand, cGMP takes things further by emphasizing the importance of continuous improvement in manufacturing processes. Their online resources explain this in simple terms.
In other words, cGMP takes a more proactive approach by requiring manufacturers to have a quality management system. It is continually reviewed and updated to improve efficiency and reduce the risk of product defects.
GMP has also been guided and recognized by WHO. The initial WHO draft text on GMP was sanctioned in 1968 and deemed an essential element of the WHO Certification System the following year.
This was when the World Health Assembly put forward the first version of the scheme for evaluating the quality of pharmaceutical products traded globally. Since then, over 100 countries have incorporated the WHO GMP standards into their national drug laws.
To comply with regulatory requirements, manufacturers must design cleanrooms that meet the standards outlined in GMP and cGMP.
2. Cleanroom Classifications
The cleanroom classification system describes the level of cleanliness and the maximum allowable concentration of particles in the air within the cleanroom. The classification is determined by measuring the number and size of particles in a specified air volume.
An arrangement of cleanrooms by their level of cleanliness has been established by the International Organization for Standardization (ISO), which ranges from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean). The highest acceptable concentration of particles per cubic meter of air decides the classification.
Cleanrooms designed for healthcare manufacturing typically fall into the ISO 5 to ISO 8 range. ISO 5 and ISO 6 cleanrooms are required to produce sterile products, while ISO 7 and ISO 8 cleanrooms are suitable for producing non-sterile products.
Moreover, the reference standard and its measurements determine the permitted particle counts for an ISO 8 cleanroom. ISO 8 cleanrooms are sometimes called Class 100,000 cleanrooms following US Federal Standard 209E, states Cleanroom Technology. Also, it’s worth noting that the HEPA filtration system has to be 99.97% effective and a minimum of 20 air changes per hour.
3. Design and Layout
A well-designed cleanroom will provide a controlled environment that minimizes contamination risk and promotes medical products’ safety and quality.
As a start, you need to determine the appropriate size and layout of the cleanroom. One must consider the manufactured products, the number of personnel working in the clean room, and the required workflow. The layout should provide a logical flow of personnel and materials, minimizing the risk of contamination.
Another critical design consideration is the selection and placement of air filters. The air filtration system is the primary method of maintaining cleanliness within the cleanroom. Therefore, the placement and number of filters must be carefully chosen to ensure air quality meets the required standards.
4. Contamination Control
Contamination control is a critical aspect of cleanroom design. The goal is to minimize the introduction and spread of contaminants within the cleanroom environment to ensure that medical products are safe for use by patients.
A key aspect of contamination control is personnel training. Personnel must be trained on proper cleanroom behavior, including gowning procedures, hand hygiene, and movement within the cleanroom. Personnel must also be aware of the potential sources of contamination, such as the shedding of skin cells or hair, and take steps to minimize their impact.
5. Airflow and Filtration
The air within the cleanroom must be continually filtered to minimize the concentration of airborne particles that could contaminate the products being manufactured.
One of the most critical components of a cleanroom’s airflow and filtration system is the High-Efficiency Particulate Air (HEPA) filter. HEPA filters are specifically created to eliminate a minimum of 99.97% of particles that are 0.3 microns or bigger. It is vital to frequently examine, upkeep, and substitute the filters to guarantee they work effectively.
The airflow within the cleanroom must be carefully controlled to maintain a clean and sterile environment. The airflow should be designed to move from clean to dirty areas to prevent the spread of contaminants. It can be achieved by creating positive pressure within the cleanroom, which forces the air out of the room and prevents outside contaminants from entering.
6. Validation and Testing
Validation and testing are crucial aspects of designing a cleanroom. First, the cleanroom design must be validated to ensure that it meets the necessary standards for cleanliness and safety. Then, once the cleanroom is operational, it must be regularly tested to ensure that it continues to meet these standards.
Validation typically involves a series of tests to confirm that the cleanroom meets the necessary specifications. It includes testing for particulate levels, air pressure, and air exchange rates. The validation process also includes testing the cleanroom’s HVAC system and the effectiveness of its filtration system.
7. Training and Documentation
Proper training ensures that personnel understand the cleanroom’s requirements and can effectively carry out their responsibilities to maintain a clean and sterile environment. In addition, documentation provides evidence of the cleanroom’s operations and compliance with regulatory requirements.
Personnel working in the cleanroom should receive comprehensive training on the cleanroom’s design, operating procedures, and safety protocols. Furthermore, the instruction should encompass gowning and clothing procedures, antiseptic methods, and regulating contamination. Repeated review training ought to be offered to strengthen these practices.
Healthcare Manufacturers May Design the Best Cleanrooms by Following Best Practices
According to Research and Markets report, in 2022, the market for cleanroom technology was estimated to be worth USD 4.78 billion, and by 2028, it is anticipated to be worth USD 6.92 billion. Moreover, it is projected to expand at a CAGR of 6.38% from 2024 to 2028.
Consumer attention to personal health increases as individual income rises, which drives up demand for drugs, hospitals, and medical equipment.
It has led to an escalation in demand for cleanrooms, and therefore, developing a cleanroom for healthcare production necessitates meticulous deliberation of multiple factors. By following best practices and guidelines, healthcare manufacturers can create a cleanroom that meets the necessary standards for cleanliness and safety.