Blog: Pharmaceutical Manufacturing Facilities - 10k Class Cleanrooms
The pharmaceutical industry has flourished because of 10k Class Cleanrooms. Although cleanrooms are widely used in many other fields, their merits are more prominent in the medical fields.
Over the years, the means of creating medicine have been improved thanks to our technological advancements. However, the general populace is unaware of what kind of facilities are used in producing pharmaceutical agents. The 10k Class Cleanrooms are usually a very viable option for carrying out such operations. Because of tight safety procedures and precautionary measurements, the 10k Class Cleanrooms are widely used by manufacturers all over the world. Cleanrooms are taken care of by people of various professions to ensure peak efficiency.
Contamination Control
Producing and researching pharmaceuticals require a clean and sanitized environment. This is why extra measurements have to be taken to emulate such an ideal atmosphere. Cleanrooms usually have to deal with an assortment of contaminated agents. Particulates, chemical fumes and oils, and foreign organisms always risk contamination.
Oil, metal dust particles, fumes, etc., are common byproducts of chemical reactions which need to be dealt with. The 10k Class Cleanrooms also have to deal with any unwanted organism from the outside, such as bacteria, fungi, insects, or even rodents. Ultraviolet radiation can also compromise operations carried out inside. Environmental control generally means thorough inspection of the entrance and exit of the premises. 10k Class Cleanrooms are also equipped with HVAC and microbial observation systems.
Personal Hygiene
the greatest threat of contamination is the personnel themselves. Over 75% of the overall contamination rate originates from the people who use the 10k Class Cleanrooms. This is why personal responsibilities should never be neglected once someone decides to work in a cleanroom.
Humans shed tiny dead skin cells continuously and bring along many microorganisms with them. Skin, hair, makeup, etc., are common in every human being. It is always advised to wear sanitized personal protective equipment before entering a 10k Class Cleanrooms. Contamination can risk the entire internal operations and research procedures. Assessing the room's microflora is often needed to establish the effectiveness of the room.
Air Flow Distribution
To maintain a particulate-free airflow inside the 10k Class Cleanrooms, HEPA (High-Efficiency Particulate Air) or ULPA (Ultra Low Particulate Air) filters are used. This ensures the laminar flow of air. That means the airflow is directed in a horizontal direction. The filtered air is streamed to the filters on the walls. Unidirectional air principles are usually employed on almost 80% of the ceiling.
The most common material used in constructing the filters and hoods is stainless steel, although many other non-shedding metals can be used as well. 10k Class Cleanrooms also utilize turbulent airflow. Non-unidirectional airflow uses nonspecific airflow filters, along with the laminar method.
Environment Monitoring
As the entire process of the 10k Class Cleanrooms is integrated with complicated procedures, keeping an eye on them is absolutely necessary. There are different aspects of this that need to be kept under control. The monitoring system is essential to keep the operations running. Particulates in the air need to be monitored every 6 months or so.
The air changing rate calculations, differentials of air pressure, HEPA filter testing are all part of the process. Some need to be done on a daily basis while others can be frequented every 6 months. Things like temperature, humidity, and microflora should be monitored daily as these are the most sensitive entities of any operation.
Conclusion
Cleanrooms are essential in manufacturing pharmaceutical products. They are built to provide and sustain an ideal and amicable environment where the users can operate efficiently.
