Learn more about Clean Rooms
We are excited to announce that our new ISO 8 Certified - Class 100,000 clean room is now complete and in operation.
We created this webpage to help you to gain a better understanding of the use of clean rooms.
- What is a clean room?
- What are Federal Standard 209E for Clean Rooms?
- Why did ISM build a clean room?
- What happens if ISM loses electricity?
- What would contaminate a clean room?
- What rules do employees have to follow to avoid contamination?
- How do I contact IS Med Specialties?
In the most basic sense, a clean room is an enclosed area employing control over the particulate matter in the air with temperature, humidity and pressure control as required. To meet the requirements of a 'clean room' as defined by generally accepted standards, all clean rooms must not exceed a particulate count as specified in the air cleanliness class. The IS Med Specialties (ISM) clean room is regulated to the Class 100,000 standard; meaning that the particle count inside does not exceed 100,000 particles per cubic foot. To provide a little background, the U.S. Federal Government established standards that were applied throughout the world (such as Class 100,000). More recently, global clean room classifications and standards have been adopted by the International Standards Organization (ISO). The Class 100,000 clean room is equivalent to an ISO 8 clean room standard.
A clean room is built in a contained space and controls environmental parameters such as humidity, pressure and temperature. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are as small as 0.3 micron in size. HEPA filters are essential in providing contamination control.
Extensive training is required for persons who work in clean room environments. They enter and exit the clean room through airlocks or gowning rooms. Special clothing must be worn in the clean room to trap contaminants that are generated by the body.
A clean room design encompasses the entire air distribution system, including downstream air returns. They are designed to achieve and maintain airflow in such a way, that the entire body of air inside the clean room moves in uniform velocity along parallel flow lines, (laminar flow).
Clean rooms are classified by how clean the air is. In Federal Standard 209E, the number of particles equal to and greater than 0.5mm is measured in one cubic foot of air, and this count is used to classify the clean room. (See chart below).
- maximum particles/ft³
- ≥0.1 µm
- ≥0.2 µm
- ≥0.3 µm
- ≥0.5 µm
- ≥5 µm
- ISO 3
- ISO 4
- ISO 5
- ISO 6
- ISO 7
- ISO 8
ISM built a clean room as a service to our medical customers who are seeking to purchase disposable medical filtration products manufactured by ITW-Filtertek in smaller packaged quantities than that provided by the manufacturer. Our new clean room allows us to repackage these premium medical products in smaller quantities for our customers without the introduction of additional particulate matter or bio-burden.
IS Med Specialties has taken every preventative precaution with the clean room including an alarm system that will notify an on-call employee if the electricity is lost to the clean room. If this event were to occur, the clean room will be thoroughly cleaned and tested for contamination. We will take no risks of contamination.
Any particle as small as one micron can contaminate a clean room. To put this into perspective, the thickness of a human hair is 100 microns. A primary source of contamination is exposed skin or hair. We provide employee¡¯s gowns, booties, masks and gloves as a precaution. The clean room also uses ventilation to prevent these contaminates from getting into the product packaging. After all, a motionless human, sitting or standing will generate 100,000 particles >0.3 micron in diameter per minute. Please see the chart below for examples of particles that are generated from people activity.
- PEOPLE ACTIVITY
- PARTICLES/MINUTE (0.3 microns and larger)
- Motionless (Standing or Seated)
- Walking about 2 mph
- Walking about 3.5 mph
Employees are provided with gloves, gowns, masks and booties. Employees are not to wear perfumes, make up, lotions or aerosols inside of the clean room. No personal items are to be carried into the clean room. No one who is physically ill may enter the clean room. In addition, there are personal actions that are prohibited in the clean room including scratching head, combing hair, removing garments prior to gowning area, fast motions, improper changing of gloves, etc. Management of housekeeping is an essential part of the overall cleanliness of any clean room. There are required procedures for each class of clean room. For example, a Class 100 clean room requires the wiping down of walls and trim to be preformed on a weekly basis. A Class 1000 clean room may have more rigorous housekeeping regulations such as, using a DI cleaner (De-ionized water) and an approved wet mop to clean up to 2 times per shift.
For additional information, or to get a quote on our quality disposable medical products, please call: 303.781.8486 or toll free at 800.781.8487, visit us online at ismedspec.com