Safe & Sterile: Reasons to Use a Cleanroom
Medical and electronic materials and packaging must be made in a cleanroom. Contamination can mean the materials are rendered useless. This is especially true of medical materials, where contamination might mean illness and infection.
Cleanroom products are produced in a sterile facility that meets the strict requirements of both the FDA (Food and Drugs Administration, US) and the EEC (European Health Authority).Raw medical materials created in these rooms are also made under strict quality control.
What Makes a Cleanroom?
A cleanroom has almost every aspect of its environment regulated. This includes air pressure, temperature, and humidity, which are the most aggressive culprits when it comes to contamination. When these elements are controlled and things are kept sterile, quality is assured.
Cleanroom products are produced in an atmosphere with much higher air pressure than the outside environment.
Materials within the sterile environment, from the walls to the equipment, are chosen based on their level of sterility. This means that they do not emit particles, nor do they cling to them.
Cleanroom thermoforming allows the temperature to remain at the optimal level to avoid contaminants.
Workers wear protective clothing that prevents stray skin and hair cells as well as respiratory particles from entering the environment. They don the clothing in a sealed room between the outdoor environment and the cleanroom.
These extensive measures work to protect the cleanroom from contamination and assure the functionality and safety of all the products within that environment.
How Do You Know the Cleanroom is…Well, Clean?
Cleanrooms are measured by particles per cubic meter. The filters measure the particles in the air to ensure the environment is clean.
Cleanroom classifications dictate that 0.5µm particles per cubic meter or less is acceptable for ISO 7 standard, the most common in the United States. These classifications run from ISO 1 to ISO 9. ISO 1 is the cleanest, while ISO 9 is only slightly cleaner than an average room.
What are Cleanroom Products?
Several items are produced and assembled in cleanrooms. Usually, these are medical-grade items and electronics.
Assembly in a sterile environment ensures each piece of the item or packaging isfree from contaminants while being introduced to each other. Meanwhile, cleanroom injection molding is essential in producing sterile plastics used in medicine, food, and electronics.
Cleanroom Thermoforming through CleanPack
CleanPack offers cleanroom thermoforming applications. Packaging and cleanroom assembly solutions offered in-house allow us to cater to our customers’ specifications.
For 45 years, CleanPack has offered cleanroom services that meet the strict ISO standards. This ensures that you know your products are free from contamination and your quality is reliable.
With conditions that meet the cleanroom classification ISO 6 requirements and the latest thermoforming machines, we are ready to take on any projects, no matter the quantity.