The precision path is the route that leads to success. The same principle applies to cleanroom construction. To construct a cleanroom environment that meets your needs, it’s important to follow a few essential rules. Achieving this goal requires collaboration between facility owners, engineers, and others who are involved in the process.
Following the regulations will help you avoid any legal and economic consequences. The global cleanroom technology market size stood at $3.6 billion in 2022. It is expected to grow at 5.58% from 2023 to 2030. This means the competition will increase further as the industry grows.
Abiding by the regulations will help you get ahead of the competitors who don’t follow them. Hence, we have crafted this comprehensive article that lists some essential rules for building a cleanroom environment.
The Foundation: Understanding Cleanroom Classification
The first step is to understand how it’s classified. The classification is based on two factors: the amount of contamination allowed and how many particles per cubic foot exist in that environment.
The classification system is also broken down into three subcategories: particle size, particle type, and number of particles per cubic foot. It ranges from Class 100 (the cleanest) to Class 10,000 (the least clean). Class 10,000 is identified as equivalent to ISO 8.
Rule #1: Designing for Contamination Control
Designing a cleanroom environment is a continuous process, not an event. It’s important to understand that it’s not just about designing the room itself. It’s also about how you plan to use the environment and what might need to change over time.
The design process should be iterative. You’ll need to constantly adjust as you learn more about what works best for your particular application. That means being flexible enough in your thinking so that when things change, or new information comes up, you can make adjustments.
It’s also critical that this process be based on data. Know what contamination levels are acceptable at each stage of production. This will ensure that any decisions made during construction take into account factors such as product yield versus the risk of cross-contamination between batches.
Based on what you will use the cleanroom for, you might also have to follow some other regulations. For instance, American Cleanroom Systems states that if you are preparing compound sterile preparations (CSPs), you must comply with USP chapter 797. However, this is required only if the CSPs meet the criteria mentioned in USP 797.
The requirements mentioned in this chapter are largely general. But they refer to the ISO-14644 standards. The primary requirement to comply with USP 797 is that pharmacies should conduct sterile drug compounding in an ISO 5 cleanroom. Additionally, it should be enclosed within an ISO 7 standards environment.
Rule #2: Materials and Finishes Selection
You’ve got a lot to consider when it comes to materials and finishes. The importance of cleanliness is paramount, but you also need to ensure that the surface of your materials is free from any contaminants. Let’s take a look at some tips for making sure that happens:
- Use only approved products in your cleanroom environment. This means no hairspray or hand lotion, which can leave residue on surfaces and contribute to contamination issues over time.
- Ensure all surfaces are smooth, flat, and free from cracks or chips. Any rough edges present may harbor bacteria or other microbes that can contaminate sensitive equipment being operated inside the cleanroom environment.
- Consider using non-porous materials such as stainless steel rather than glass when possible because they’re easier to keep clean.
- When selecting furniture pieces such as desks and chairs, make sure they have no stains or scratches. Otherwise, these areas may harbor germs like mold spores, which could then spread through an entire facility if left unchecked.
- The walls and ceiling finishes must be easy to clean and smooth. Moreover, all crevices, corners, and joints that can collect dirt should be minimized and filled, if possible. Moreover, all the equipment must have low electrostatic properties to avoid particles sticking to the equipment.
Flexible and transparent 60 µm thick polyvinyl chloride foil containing silver-based agent with 2% silver ions is often used in patient rooms. It is used across healthcare systems, as it can reduce the burden of pathogens by more than 50%.
Rule #3: HVAC Systems and Environmental Controls
The HVAC system and environmental controls are essential to maintaining a cleanroom environment. The HVAC system must be designed to meet the needs of the cleanroom. It should also be able to remove contaminants from the air before it is exhausted out into your facility.
The first step in designing an effective HVAC system is determining what type of construction you will use for your walls, floors, and ceilings. If you are planning on using a single-level structure with standard wall and ceiling panels, standard air filters should work fine.
However, if you plan on having multiple levels, more sophisticated filtration methods may need to be employed. These may include electrostatic precipitators (ESPs), which filter out particles by charging them with electricity.
The laminar airflow ceiling is in the range of 0.15–0.25 m·s−1 in clean rooms. The best flow rate setting increases the efficiency of particle reduction or infiltration in the operating table area by up to 54%. This can also reduce operating costs. Particles of 0.5 μm are typically monitored according to ISO EN 7.
Rule #4: Personnel Protocol and Cleanroom Behavior
When you are working in a cleanroom environment, it is important to follow certain rules to maintain a high level of cleanliness. This means that you must avoid contaminating your work area and keep everything as clean as possible at all times. Here are some tips for doing so:
- Avoid touching anything in the cleanroom except what is necessary for your task at hand. If you need something from another area of the lab or from outside, ask someone to bring it over.
- It’s also important that people avoid touching their faces while they’re inside the sterile zone. They should also avoid disturbing any surfaces there. This includes wiping them down with disinfectant wipes regularly throughout each shift.
Conclusion
Cleanrooms are a critical part of the manufacturing process, but they can also be challenging to build and maintain. By following these four simple rules, you’ll be able to create a cleanroom environment that complies with industry standards and is efficient.