Forum Plastics is pleased to announce that we have received the ISO Class 7 Certification for cleanroom assembly. With this certification, our industry-leading assembly services are performed in an ISO Class 7 Cleanroom.
What an ISO Class 7 Certified Cleanroom Means
Cleanrooms are designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. Cleanrooms typically have a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. For example, the ambient outdoor air in a typical urban area contains 35 million particles for each cubic meter in the size range of 0.5 μm or larger.
Forum Plastics’ cleanroom is an ISO Class 7 Certified Cleanroom (or Class 10,000), meaning it will have less than 352,000 particles for each cubic meter in the size range of 0.5 μm.
Cleanrooms and Medical Devices
Medical devices are built for use in healthcare settings where hygiene and contamination prevention are paramount. If air pollutants get into the mechanisms of small medical devices, it can prevent them from functioning properly. One way to ensure cleanliness is to manufacture these products in a controlled and sterile environment. This is why cleanrooms are a key element of the production process.
High-efficiency particulate air (HEPA) filters are often the tool of choice in medical device cleanrooms because they remove 99.97% of particles from the air — efficient to at least 0.3 microns (0.0003 mm) in size. The other way manufacturers can prevent contamination in cleanrooms is by ensuring that staff wear gowns, hairnets, gloves, and sometimes overshoes to reduce the chance of introducing contaminates that may be attached to their clothing and bodies.
Our Commitment to Cleanliness and Safety
At Forum Plastics, our employees are trained to understand and respect the high level of personal hygiene and attention to detail required to operate in a cleanroom environment. Ultimately, this keeps our manufacturing environment free from contaminants. Our commitment extends to the processes and procedures for operating and working in a cleanroom, including:
- Following a gowning process
- Eliminating cardboard
- Using a pass-through chamber to transfer components in and out of the cleanroom
- Using a tacky matt so that the bottoms of shoes and shoe covers are debris-free
Forum also maintains the correct supplies and equipment required for sustaining the cleanroom integrity. We make sure equipment is used and disposed of properly, as well as keeping a cleanroom maintenance schedule. These processes, along with regular risk assessments, drive continuous improvement to help us respond to contamination threats caused by new technologies.
Forum Plastics is a world-class plastic injection molding and manufacturing solutions provider. Contact Doug Hungerford, Director of Engineering, to learn more about our assembly solutions and ISO Class 7 Certification.