Cleanrooms are very important for the pharmaceutical and specialty industries because they are where compliant products are made. To make sure that the products made in these rooms meet industry standards, the production conditions must be closely monitored.
Pollutants, dust, and anything else that could be dangerous must be watched for and maintained to a legally acceptable minimum. Every aspect of the space’s design and use must be carefully considered to properly reinforce control and responsibility for this controlled setting to function.
Why Coving Is Needed in Cleanrooms
In cleanrooms, coving makes sure that the angles are smooth and have no sharp edges. This facilitates cleaning and prevents material accumulation. Coving keeps cleanrooms efficient and simple to clean in sterile areas such as food processing, pharmaceutical manufacturing, clinical labs, and other similar settings.
Current good manufacturing practices, aka cGMP compliance in cleanrooms, say that coving is needed. Facilities must install it in order to follow the rules and keep their work areas clean. More than just general or generic standards and practices are involved in the requirements for clean rooms. In reality, they are a regulated set of guidelines for good manufacturing practices.
The Code of Federal Regulations governs these manufactured goods and medications. The cGMP for Finished Pharmaceuticals contains information on clean rooms from 21 CFR 600 to CFR 680. These provide crucial specifications for biological products.
The FDA has rules pertaining to compliance. More general CFR 210 and CFR 211 regulations are superseded by regulations that are specific to drug products. The reasons for these rules have everything to do with reducing the chance that contaminants will build up and making it easier to clean the space regularly. How well these efforts work depends on how the rooms are built, their shape, and the materials that are used inside them.
Why Are 90-degree Angles Undesirable?
Coving keeps dust, dirt, bacteria, and other debris from collecting in corners because it doesn’t have any 90-degree angles. When coving is put upright, it stops water or other chemicals from getting into the walls.
It is also easier to clean coving thoroughly because the materials are made to stand up to regular cleaning and because the shape makes it easier to clean thoroughly than a right-angled corner.
Getting rid of corners also makes it easier for air to flow through these rooms. This helps control airflow, temperature, humidity, and pressure.
Depending on the rules of the building, coving is usually made of plaster, metal, aluminum, or plastic. It can be treated or covered to make it better. These materials are made to be cleaned over and over again, and they often have silicone edges to help seal out air. Each type of material and finish has its own advantages.
Aluminum coving is a good choice if you want something that is resistant to damage or corrosion, and it is easy to add more finishes to make it even stronger. PVC coving can be made stronger with materials like metal or glass, and its surface can stand up to being cleaned hard and often.
Polystyrene coving is the lightest option, and it will cost you the least. Unfortunately, it’s also the most likely to get broken, so it’s not a good cleanroom solution without extra support.
Most of the time, wood finishes are used for their looks and not their functionality. Even after being sealed, wood coving can’t stand up to the wear and tear of a cleanroom.
Before other options came along, people usually used plaster coving. Plaster works well for things like fixing up old buildings, but it is heavy and easy to break.
Hardened polyurethane is cheap, doesn’t weigh much, and is easy to install because it can be bent around windows and other decorative features. It’s not thought to be a very durable material, which is a huge drawback.
As was already said, there are different finishes that can be added to materials to make them better able to handle certain conditions. Using an electrostatic charge, powder coating sticks powder to a surface, hardening it and making it more resistant to wear and tear.
An alternative is to anodize the surface with aluminum, which can make it resistant to corrosion and make it stick better without changing the surface’s strength.
Errors With the Coving
If coving isn’t installed properly, it can be easy for the integrity of its installation to be broken, which limits its ability to protect. The coving is made to be resistant to chemicals, so it can handle both daily cleanroom tasks and regular cleaning.
Protocols say to clean every day, but with coving in place, that cleaning is more effective and takes less time. When coving is put upright, there are no seams, which makes it harder for biological, chemical, or other agents to get in. If the coving is not secure, it can get dirty and build-up.
Tips to Consider Before Coving
Most coving is also made resistant to temperature changes, so it can handle some changes in temperature without losing its structural integrity.
When putting up coving in a cleanroom, there are a few important things to keep in mind. The surfaces in a cleanroom must be clean and plain so that they can be cleaned easily and don’t let any dust or dirt build up. Any seals used to hold the coving materials together should be made of FDA-approved silicon that isn’t likely to grow mold or other contaminants.
All of the materials in a cleanroom must also be able to handle the use of industrial-grade cleaners on a regular basis.
The coving needs to have channels built into it so that utility cables and even panels can go through them. If anything else needs to be checked, the coving should be made so that it is easy to move. Air ducts and diffusers should be made in a way that keeps them clean and keeps the air moving.
When installing coving, you also have to think about the surfaces it will go on. All surfaces, including floors, need to be impermeable so that contaminants can’t hide in them. The floor must be able to handle constant friction and possible abrasions, and it must also be safe to walk on.
It must also be able to hold a heavy load that stays still for a long time or moves around a lot without having to be changed. As an extension of the floor, these need to be taken into account by the coving.
Walls need to be easy to clean and not take in dust or chemicals. In a lab, there are many fixtures that need to be sealed together so that they are easy to clean and don’t get too dirty. Again, the coving needs to be an extension of the wall’s features.
Doors also need to be made so that they don’t let air in or out when they are closed, which could lead to cross-contamination. Any coving must be in-line with the doors, and the two must work together to reinforce best practices in the cleanroom.
All cleanroom surfaces must also have lighting that is suitable for them. Many lights are made to be turned on and off outside of the cleanroom so that the room’s integrity can be kept and the airflow can be disturbed as little as possible. Again, coving must be used to work with the lighting to keep the cleanroom’s adherence to cGMP guidelines intact.