Pharma humidity control is the process of retaining standardized humidity values in a specific area, which is critical for the quality, integrity, and safety of a product.
Pharma humidity control refers to the techniques for maintaining the humidity of a certain area or department within acceptable limits. It conditions the incoming air in a way that decreases or increases the moisture content in the area or environment, and the humidity becomes within acceptable limits.
Pharma humidity control is critical because humidity affects product characteristics, personnel working, and equipment performance. They directly impact the product characteristics of every form at all stages.
Humidity levels in the pharmaceutical industry are kept within limits through external equipment. This equipment dedicatedly performs humidity control and is incorporated in the desired area or department through suitable means. For example, this equipment can be part of the HVAC system to perform humidity functions as a part of routine airflow.
How pharma humidity control affects the production process
Let’s discuss the impact of unregulated humidity levels in a pharmaceutical organization.
Pharma Drug manufacturing
Humidity levels affect the drug manufacturing process by altering the chemical bond between different materials in the drug substance.
The chemical reaction between different materials of an approved drug depends upon particular humidity levels of the manufacturing area. If the required humidity levels are not provided during manufacturing, the raw material’s chemical properties will be affected, and the output will deviate from the approved acceptable limits.
Uncontrolled humidity also results in static electricity, which causes the electrostatic discharge. Because un-controlled humidity lowers the surface resistance, especially of the metallic surfaces, and increases its conductivity. In the case of uncontrolled humidity, the air becomes part of the electrostatic build-up every time there is an airflow. This condition becomes dangerous for the equipment and operators – equipment can face the danger of an electric short circuit, and the operator can receive an electric shock.
This condition can be prevented by lowering the humidity, which lowers the air’s moisture content and the air becomes insulated. The insulated air does not provide favorable conditions for static electricity and minimizes the danger of short circuits and electric shock.
Uncontrolled humidity also increases dust particles in the air, thereby increasing the risk of contamination. Additionally, the moisture content in the air is the major reason for contamination, microbial growth and accumulation of foreign bodies, and it affects the serving area.
Controlling humidity levels result in dry hair, which has a reduced ability to carry dust in them and subsequently reduces the risk of contamination.
For packing operations, humidity levels can result in the degradation of the final finished product waiting to be packed. For solid oral products, it degrades the bond between different chemical compounds and, as a consequence, loses its strength.
Excessive humidity levels also affect the packaging material and can degrade the sealing capacity of packing material, and results in failed leak tests and integrity testing. Excessive humidity levels can contaminate the packaging material, eventually destroying the Pharma product.
A warehouse in a pharmaceutical organization is used to store Pharma products temporarily. They are either stored before the production process such as raw material – or after the production process, in final finished form. The humidity of a warehouse is controlled to protect the integrity and efficiency of these products.
Uncontrolled humidity levels in the warehouse can affect the packaging material and decrease its strength if stored for longer, making it difficult to pack the pharma product. Additionally, uncontrolled humidity levels can change the packaging material’s properties and contaminate the packaged product.
Uncontrolled humidity levels also affect the normal person in the area and can compromise their work. It can increase the body temperature and can become difficult for them to work.
This condition can become critical for areas that require gowning for personal protection, such as clean rooms and sterile production areas.
How to perform Pharma humidity control
There are many ways to control the humidity in pharmaceutical industries, such as heat and cool air. These two methods are not an effective method. Instead, the pharmaceutical industry uses a desiccant dehumidifier to control the humidity levels.
The desiccant dehumidifier uses desiccant material, which naturally tends to absorb moisture. The air is made to pass through the desiccant material contained within a mechanical structure. When air passes through the desiccant material, it lowers the moisture content in the air and makes it dehumidified. The resulting air from this process becomes dry, and its temperature is increased. This heated air’s temperature is lowered within acceptable limits by passing it through the heat exchanger or cooling coils.
Desiccant dehumidifier successfully reduces absolute and relative humidity. This also protects the air from microbial growth, resulting in less maintenance due to less wet conditions.