In today’s world, the pharmaceutical industry is taking tremendous strides and becoming a major player in the global economy. Market studies reveal that the pharmaceutical industry was valued at US $405.52 billion in 2020. This is further estimated to increase at a CAGR of 11.34% from 2021 to 2028.
A lot of this has to do with increased research and development, as well as better production facilities that can produce high-quality products at an affordable price. Still, there are certain aspects of the business which must be taken into account when planning for new clean rooms for your pharmaceutical business.
Classification of Cleanrooms
First things first, it is important to understand that there are different types of cleanrooms. The classification of cleanrooms is based on the purity level guaranteed by each class.
There are six classifications: Class 100,000, Class 10,000, Class 1000, Class 100, Class 10, and Class 1. The higher the number in each classification, the lower the level of allowable contamination and the cleaner the cleanroom will be.
The most common classification is Class 100,000. This means that the air in the room has less than 100,000 particles per cubic foot of air. This level of purity is achieved by using HEPA filters and effective ventilation systems.
Other classifications include class 1,000 with 1000 particles per cubic foot of air. Class 100 with just 100 particles for every cubic foot of air volume. And class 10 has a maximum number of ten particles per cubic foot of air.
The performance of a cleanroom depends on its class. Therefore, manufacturing industries need to identify the level of cleanliness they require before deciding on a class for their cleanrooms.
Air Flow Direction
The airflow of your cleanroom should be clean to dirty. The cleaner the environment, the more likely it is that anything in the room will remain clean.
Do not allow dirty air to enter a clean area. While this may seem obvious, it can be difficult to maintain when large equipment and machinery are involved. Let’s say you are manufacturing pharmaceuticals in an assembly-line manner with large machines that require frequent maintenance or replacement parts.
That means there will inevitably be areas where dirt and dust become concentrated on your work surfaces or even within machine components themselves. When this happens, make sure those areas are kept separate from your clean area so they don’t contaminate it.
Temperature, Pressure, and Humidity
The temperature and humidity of your cleanroom are two important factors that need to be kept in check. The ideal temperatures for a clean room range between 68 and 77 degrees Fahrenheit, so it’s important to make sure that the room is well-ventilated and doesn’t become too hot or cold.
Humidity should also be monitored as well. As you may already know, humidity can play an important role in mold growth. In most cases, manufacturers prefer for their facilities’ relative humidity levels to remain between 40% and 60%.
A higher concentration of moisture can lead to bacteria growth, while lower levels could cause condensation on surfaces like walls or tables. Both of these are not desirable outcomes.
Filters
Filters are used for removing the fine particles that are present in the air. However, it is important to know that filters should be changed regularly and cleaned regularly as well.
If not, these particulate contaminants will get accumulated on them and will cause harm as they increase in size over time. Filters should also be disposed of properly so that they do not get released into the environment or back into your cleanroom, which will contaminate it again.
Surface Finish
A surface finish is the smoothness of a material’s outer layer. A surface finish can be measured in terms of its roughness or its ability to reflect light in a predictable way. A material with a high degree of reflection and smoothness will have a high specular gloss, whereas one with less reflection and a rougher texture will have a lower specular gloss.
The purpose of having a smoother surface is that it reduces friction between two surfaces when they come into contact with each other. This helps with movement and overall functionality.
For example, if you were trying to slide something across your kitchen countertop without any friction on the table itself, it would be much harder than if you were able to use something like wax paper which provides more drag than bare wood.
Air Changes per Hour Rate
An important factor to consider when choosing a cleanroom is the Air Changes per Hour Rate. This is the number of times that the air in your cleanroom is replaced every hour. The Food and Drug Administration recommends a minimum rate of 20 air changes per hour for every cleanroom. The dimensions of the room and how much time it takes to clean will also determine what ACH you need.
A low ACH means there will be less contamination brought into your facility. However, it also means that there won’t be as much fresh air being circulated around your employees or patients either. If you work in a small room with very little airflow, then an increased ACH could cause problems with dust buildup on surfaces and even create debris where there shouldn’t be any.
Conclusion
Pharmaceutical cleanrooms are critical for the development and production of sterile drugs, biologics, and vaccines. They’re used to prevent contamination during the manufacturing process, which is important because any contamination can lead to potentially dangerous side effects.
It’s important to note that not all cleanrooms will be suitable for each pharmaceutical industry. This is because the pharmaceutical industry is diverse. There are many different chemical processes and manufacturing steps to consider when choosing your cleanroom.
It’s important that you choose a cleanroom that has been designed specifically for your needs. This will ensure that the air quality is optimal for your specific process and reduce any risk of contamination during production.
