Pharmaceutical Clean Rooms
Article provided by: Pacific Environmental Technologies, Inc.
Cleanrooms are some of the most recognizable facilities in environments like healthcare. The use of cleanrooms is an essential part of containing airborne particles and maintaining the cleanliness of gears and surfaces. A cleanroom is different from an ordinary room because it helps control the environment by limiting particles generated by people, processes, and equipment.
Types of pharmaceutical clean rooms
A conventional cleanroom will usually have enough air supply, air pressure, and HEPA filtration to compound unnecessary particles. Cleanrooms are dividable into two major categories:
- Soft wall rooms
- Hard wall rooms
Both types have filtered air from the outside and HEPA filtrations to control the expended air.
Soft all clean rooms
This type of USP 797 cleanrooms for sterile compounding pharmacies is usually portable and easily expandable. The walls have pressurized polymers instead of hard material like steel. Its curtains have the support of an aluminum frame and the ceiling grid.
The soft walls allow entry and exit of users through an entrance that can easily open and close. Manufacturers design the soft wall with additional sterile compounding cleanroom supplies like castors and adjustable ceilings.
Hard wall clean rooms
These rooms have cleanroom products for compounding pharmacies like solid panels with various materials and the support of a hard frame with the ceiling grid and the roof. Each element offers a different level of strength and ensures delicate features like electronic applications do not combust or release gas.
Class 100 cleanrooms
These cleanrooms allow up to 100 airborne particles for each cubic foot. They adhere to the ISO 5 standard clean rooms and permit few particles to permit applications that include semiconductor fabrications and nanofabrication. Entering these rooms requires one to wear special shoes or a full body suit to minimize the release of unwanted particles.
Class 1000 cleanrooms
These rooms allow 1000 particles for each cubic foot, which is the equivalence of ISO 6. While this level is not as stringent as ISO 5, it helps in limiting particles from lint, dust, hair, skin, lubricants, paint, and air conditioning machines. This case means that they require the same amount of care, meaning technicians should only enter with a full-on bodysuit.
Class 1000 cleanrooms
These pharmaceutical clean rooms allow the entrance of 10,000 particles for each cubic foot and classify as ISO 7. Operators can only use these rooms when they meet the set FDA standards for pharmaceutical drug and chemical operations.
Some of our cleanrooms fall in the ISO 7 category because we use materials like stainless steel, white acrylic, and aluminum for the walls. The good news is that technicians do not need a full-coverage bodysuit, as long as they cover their hair and other exposed body parts like the hands and feet.
Important factor for an ISO 7 pharmaceutical cleanroom
Compounding pharmacies cleanrooms should have plenty of airflow and controlled humidity and temperature. This case means that a higher amount of cleanliness should have more airflow. We use proper airflow designs to recirculate as much air as necessary and flush out excess moisture, drug materials, and gases from the processes. We also include a plan that limits the movement of supplies and personnel and well-orchestrated radius corners for the best cleanroom practices and cleaning routines. Request a quote before starting a sterile compounding pharmacy of your preference.Pharmaceutical Clean Rooms
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