Did you know that the US pharmaceutical industry recorded $550 billion in annual revenue in 2021? It’s a lucrative industry to be in, for sure. A cleanroom is a critical part of any pharmaceutical manufacturing operation. It protects your most sensitive equipment, materials, and employees from contamination.
For example, a single speck of dust could ruin an entire batch of medicine. However, designing a cleanroom isn’t just about making sure nothing gets in. It’s also about making sure that everything leaves the facility without leaving anything behind.
Knowing how each process affects your cleanroom design and vice versa so you can maximize efficiency while minimizing the risk of product damage or employee exposure.
Know Your Class
Cleanrooms are classified by their cleanliness or the number of particles per cubic meter (1 m3 = 35.3 ft3). There are three classes: Class 100, 1000, and 10000. The lower the number, the cleaner and more sterile the environment is considered, and therefore, the more expensive it becomes to maintain.
Class 100 cleanrooms are generally used for automated manufacturing operations that require a very high level of cleanliness but not necessarily sterility. These rooms have less than 100 particles per cubic meter and can tolerate contamination from outside sources like dust storms outside windows or doors being opened regularly during operation hours.
Class 1000 cleanrooms have fewer than one particle per cubic meter. These areas require air filters/purifiers with high-efficiency particulate arresting (HEPA) filters. It’s to remove 99%+ airborne contaminants before they leave through exhaust systems. Keep things tidy inside without letting anything harmful into your workspace while working safely throughout production shifts.
Finally comes Class 10000, which has less than 0.5 particles per cubic meter. It means there aren’t any uninvited guests wandering around inside your workspace at all times because everything has been removed beforehand. It is done through air filtration systems installed behind walls.
That means no matter where someone goes inside their designated work space, they won’t see anything but pure white light.
Avoid Light Fixtures and Electrical Outlets
Light fixtures and electrical outlets are not compatible with the sterile environment a cleanroom must maintain. Light fixtures are sources of heat, which may damage sensitive equipment or cause contamination. Electrical outlets can also be a problem because they carry electricity, which can interfere with equipment not properly grounded and could pose a fire hazard.
Avoid these items by sealing off areas where they are located. You can use drywall partitions to divide large spaces into smaller areas for your cleanroom design to prevent light from entering through the walls and windows.
To protect your employees from injury and contamination from existing wiring, use protective barriers around all exposed electrical sources like power strips or wall outlets if possible. It will ensure that no one accidentally cuts themselves on loose wires while working inside the cleanroom space.
Airflow Is Critical
Airflow is critical in cleanrooms. The amount of airflow is measured in cubic feet per minute (CFM), the volume of air that passes through a unit area within one minute. Some manufacturers use the term cubic meters per second instead of CFM, but what matters most is having enough air circulating inside your cleanroom to ensure a safe environment for manufacturing operations.
When it comes to acceptable levels of airflow, according to WHO guidelines, 10-15 pascals of differential pressure is maintained between manufacturing and surrounding areas.
It means that if you want to keep your doors closed or restrict access by personnel wearing personal protective equipment (PPE), your facility’s door should be able to withstand pressures greater than outside pressures at all times.
A Cleanroom Is Only as Good as the Materials Leaving It
A cleanroom is only as good as the materials that leave it. To ensure your quality standards are met, you must have a thorough cleaning process. In addition to maintaining an effective cleaning regimen, you must also track how often materials are cleaned and what items are being cleaned.
Cleanrooms are designed to be easy to clean so that operators can spend more time doing their jobs instead of performing menial tasks like mopping or scrubbing. Many cleanrooms contain floors with low-maintenance coatings and surfaces made from durable materials such as stainless steel or plastic that resist dirt buildup over time.
It results in less frequent cleaning needs than other facilities, such as offices or warehouses, where occupants may walk around on bare concrete or carpeted surfaces without wearing shoes/boots (depending on the situation).
However, even if these floors were made from hardwood planks, it wouldn’t matter much because this type of facility will always require regular maintenance, just like any other building type. Because these types tend not to get used nearly as often, there’s less chance for biofilm buildup between uses. However, this doesn’t mean they never need cleaning at all.
Choose Your Doors Carefully
When designing a cleanroom, you’ll want to consider the type of doors in your space. Several options are available on the market, but certain materials are best for preventing contamination.
Cleanroom door materials commonly include Lexan polycarbonate (PC) sheeting and soft PVC (polyvinyl chloride) panels with an integrated sealed track system. Both provide excellent protection against dirt, dust, water vapor, and other elements while remaining easy to clean.
A Highly Efficient Cleanroom Design Equals a Highly Efficient Manufacturing Operation
Cleanrooms are essential for the production of pharmaceutical products. These facilities must be sterile and free from contaminants to ensure that the final product is safe and effective. In addition, these spaces must be maintained at a specific level of cleanliness at all times so that they can continue to produce high-quality goods without interruption or unnecessary delays.
The design process begins with assessing what type of facility you need based on space requirements, equipment specifications, personnel needs (if applicable), etc. This will help determine how many rooms or zones need to be included in your design plan moving forward.
Now that you’re armed with the knowledge of how to design a cleanroom for pharmaceutical manufacturing, it’s time to get started on your project. Remember that this is not a one-size-fits-all endeavor, and you will need to consider your company’s specific needs to decide what type of space will work best.